Page last updated: 2024-12-05

neostigmine

Description Research Excerpts Clinical Trials Roles Classes Pathways Study Profile Bioassays Related Drugs Related Conditions Protein Interactions Research Growth Market Indicators

Description

Neostigmine: A cholinesterase inhibitor used in the treatment of myasthenia gravis and to reverse the effects of muscle relaxants such as gallamine and tubocurarine. Neostigmine, unlike PHYSOSTIGMINE, does not cross the blood-brain barrier. [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

neostigmine : A quaternary ammonium ion comprising an anilinium ion core having three methyl substituents on the aniline nitrogen, and a 3-[(dimethylcarbamoyl)oxy] substituent at position 3. It is a parasympathomimetic which acts as a reversible acetylcholinesterase inhibitor. [Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Cross-References

ID SourceID
PubMed CID4456
CHEMBL ID278020
CHEBI ID7514
SCHEMBL ID34419
MeSH IDM0014615

Synonyms (113)

Synonym
juvastigmin
CHEBI:7514 ,
(m-hydroxyphenyl)trimethylammonium dimethylcarbamate (ester)
neostigminum
neostigmin
neostigmine [ban]
hsdb 3921
intrastigmina
prostigmine
ccris 3079
prozerin
vagostigmine
benzenaminium, 3-(((dimethylamino)carbonyl)oxy)-n,n,n-trimethyl-
ammonium, (m-hydroxyphenyl)trimethyl-, dimethylcarbamate (ester)
brn 3615946
AB00053807-25
BRD-K18922609-004-04-1
DIVK1C_000165
DIVK1C_000198
KBIO1_000198
KBIO1_000165
3-{[(dimethylamino)carbonyl]oxy}-n,n,n-trimethylanilinium
SPECTRUM_001061
prostigmin
NCGC00015730-02
NCGC00015730-01
cas-114-80-7
lopac-n-2001
BPBIO1_000634
IDI1_000198
IDI1_000165
SPECTRUM5_001234
BSPBIO_000576
PRESTWICK2_000468
PRESTWICK3_000468
AB00053807
neostigmine
C07258
59-99-4
3-trimethylammoniumphenyl n,n-dimethylcarbamate
eustigmin
eustigmine
m-trimethylammoniumphenyldimethylcarbamate
DB01400
(m-hydroxyphenyl)trimethylammonium dimethylcarbamate
prostigmin (tn)
LOPAC0_000816
NCGC00163240-01
KBIO2_001541
KBIO2_004109
KBIOSS_001541
KBIO2_006677
KBIOGR_000623
PRESTWICK1_000468
SPECTRUM4_000072
SPECTRUM2_001278
NINDS_000198
SPBIO_001276
NINDS_000165
PRESTWICK0_000468
SPBIO_002515
NCGC00015730-04
NCGC00021658-03
NCGC00015730-03
HMS2089A22
NCGC00015730-08
[3-(dimethylcarbamoyloxy)phenyl]-trimethyl-azanium bromide
[3-(dimethylcarbamoyloxy)phenyl]-trimethyl-azanium; sulfonatooxymethane
alwkgypquaplqc-uhfffaoysa-
inchi=1/c12h19n2o2/c1-13(2)12(15)16-11-8-6-7-10(9-11)14(3,4)5/h6-9h,1-5h3/q+1
neostigmine (ban)
D08261
STL058953
3-[(dimethylcarbamoyl)oxy]-n,n,n-trimethylanilinium
BMSE000762
[3-(dimethylcarbamoyloxy)phenyl]-trimethylazanium
bdbm50022775
chembl278020 ,
3982twq96g ,
unii-3982twq96g
CCG-204900
AKOS005711366
neostigmine (cation)
neostigmine ion
neostigmine cation
NCGC00015730-05
NCGC00015730-07
NCGC00015730-09
NCGC00015730-06
neostigmine [vandf]
neostigmine [mart.]
neostigmine [mi]
neostigmine [hsdb]
SCHEMBL34419
AB00053807-26
AB00053807_29
AB00053807_28
AB00053807_27
DTXSID1023360 ,
gtpl8993
MLS-0002855
SBI-0050793.P004
benzenaminium, 3-[[(dimethylamino)carbonyl]oxy]-n,n,n-trimethyl-
ALWKGYPQUAPLQC-UHFFFAOYSA-N
Q410546
3-((dimethylcarbamoyl)oxy)-n,n,n-trimethylbenzenaminium
[3-(dimethylcarbamoyloxy)phenyl]-trimethyl-azanium
BRD-K18922609-004-14-0
NCGC00015730-24
neostigmina
neostigmine (mart.)
3-((dimethylcarbamoyl)oxy)-n,n,n-trimethylanilinium
dtxcid703360

Research Excerpts

Overview

Neostigmine test (NT) is a pharmacological test, demonstrating a clinical improvement in patients affected by myasthenia gravis (MG) NeostIGmine is an acetylcholinesterase inhibitor that increases frequency of smooth muscle contraction by increasing acetyl choline at autonomic nervous system synapses. Neostigmin appears to be an effective and safe treatment option for ACPO patients with renal failure.

ExcerptReferenceRelevance
"Neostigmine is a cholinesterase inhibitor used to antagonize the residual effects of muscle relaxants and also produces an analgesic effect."( Antinociceptive Effects and Interaction Mechanisms of Intrathecal Pentazocine and Neostigmine in Two Different Pain Models in Rats.
Bai, X; Guo, J; Huang, H; Ouyang, H; Wu, S; Zhang, K, 2022
)
1.67
"Neostigmine is a non-specific broad-spectrum and inexpensive reversal agent for neuromuscular blocking agents (NMBAs)."( A comparison between cisatracurium and rocuronium-induced neuromuscular block on laryngeal electromyography recovery after neostigmine reversal in a porcine model.
Chai, YJ; Chang, PY; Chiang, FY; Dionigi, G; Huang, TY; Lu, IC; Tan, H; Tseng, HY; Wang, JJ; Wu, CW; Wu, SH, 2022
)
1.65
"Neostigmine is a widely used antagonist, but its optimal dose for elderly patients is unclear."( Optimal dose of neostigmine antagonizing cisatracurium-induced shallow neuromuscular block in elderly patients: a randomized control study.
Cao, M; Huang, H; Liao, Y; Ou, Y; Tong, J, 2023
)
1.98
"Neostigmine test (NT) is a pharmacological test, demonstrating a clinical improvement in patients affected by myasthenia gravis (MG). "( Clinical and CN-SFEMG evaluation of neostigmine test in myasthenia gravis.
Drago, F; Mostile, G; Nicoletti, A; Reggio, E; Salomone, S; Sciacca, G; Zappia, M, 2018
)
2.2
"Neostigmine is an acetylcholinesterase inhibitor that increases frequency of smooth muscle contraction by increasing acetylcholine at autonomic nervous system synapses."( Safety and Efficacy of Intermittent Bolus and Continuous Infusion Neostigmine for Acute Colonic Pseudo-Obstruction.
Barthol, CA; Foster, DB; Gutierrez, GC; Hall, R; Smedley, LW, 2020
)
1.52
"Neostigmine is an acetylcholinesterase inhibitor that ameliorates the effects of APAP-induced acute liver failure in the mouse and therefore may provide new treatment options for affected patients."( Pharmacologic cholinesterase inhibition improves survival in acetaminophen-induced acute liver failure in the mouse.
Eisenbach, C; Hoyler, B; Mogler, C; Sandig, C; Steinebrunner, N; Stremmel, W; Vittas, S, 2014
)
1.85
"Neostigmine appears to be an effective and safe treatment option for ACPO patients with renal failure."( Effective and Safe Use of Neostigmine in Treatment of Acute Kidney Injury Associated with Colonic Pseudo-obstruction after Cardiac Surgery.
Min, YW; Pyo, JH; Rhee, PL, 2016
)
1.46
"Neostigmine is a parasympathomimetic agent that has been recently investigated for use as an adjunct analgesic agent in the perioperative and peripartum period. "( Use of neostigmine in the management of acute postoperative pain and labour pain: a review.
Gan, TJ; Habib, AS, 2006
)
2.23
"Neostigmine is a treatment option for colonic pseudoobstruction. "( Use of neostigmine to relieve a suspected colonic pseudoobstruction in pregnancy.
Rausch, ME; Rosen, T; Troiano, NH, 2007
)
2.24
"Neostigmine is a novel spinal analgesic that could be a useful adjunct, but no data exist to assess the effects of neostigmine on small-dose bupivacaine spinal anesthesia."( Dose-response effects of spinal neostigmine added to bupivacaine spinal anesthesia in volunteers.
Burkhead, DL; Hodgson, PS; Liu, SS; Moore, JM; Trautman, WJ, 1999
)
1.31
"Neostigmine is a simple, safe, and effective therapy for treatment of colonic pseudo-obstruction."( Treatment of acute colonic pseudo-obstruction with neostigmine.
Freund, U; Mayo, A; Neufeld, D; Paran, H; Shwartz, I; Silverberg, D, 2000
)
2

Effects

Neostigmine methylsulfate has a quaternary ammonium group, which prevents its penetration through the blood-brain barrier. Its primary influence is believed to be due to its action on the peripheral nervous system.

Neostigmine has good efficacy in the decompression of pseudo-obstruction but is hindered by its wide side effect profile. It has been proposed as an effective treatment for ACPO as an alternative to colonoscopic decompression.

ExcerptReferenceRelevance
"Neostigmine has a similar, although longer, effect."( Effect of edrophonium and neostigmine on the pharmacokinetics and neuromuscular effects of mivacurium.
Brown, R; Fisher, DM; Fogarty, D; Kirkegaard-Nielsen, H; Sharma, ML; Szenohradszky, J, 2000
)
1.33
"Neostigmine methylsulfate has a quaternary ammonium group, which prevents its penetration through the blood-brain barrier; hence its primary influence is believed to be due to its action on the peripheral nervous system."( A female with central anticholinergic syndrome responsive to neostigmine.
Francia, A; Parisi, P, 2000
)
1.27
"Neostigmine has been shown in pediatric case series to be efficacious in some children for refractory post-operative ileus."( Case report series of a novel application of neostigmine to successfully relieve refractory ileus status post-pediatric orthotopic liver transplantation.
Balakrishnan, B; Hong, JC; Petersen, PC; Vitola, B, 2019
)
1.49
"Neostigmine has good efficacy in the decompression of pseudo-obstruction but is hindered by its wide side effect profile."( Neostigmine and glycopyrronium: a potential safe alternative for patients with pseudo-obstruction without access to conventional methods of decompression.
Adiamah, A; Ho, A; Johnson, S; Orbell, J, 2017
)
2.62
"Neostigmine has been co-administered epidurally and intrathecally with local anesthetics and other adjuncts in the obstetric setting."( A systematic review of the effects of adding neostigmine to local anesthetics for neuraxial administration in obstetric anesthesia and analgesia.
Brazzi, L; Cossu, AP; Cossu, M; De Giudici, LM; Finco, G; Mura, P; Piras, D; Saba, M; Scanu, M, 2015
)
1.4
"Neostigmine has also been successfully used for the management of recalcitrant constipation."( Management of constipation in the elderly: emerging therapeutic strategies.
Kapoor, S, 2008
)
1.07
"Neostigmine has been used in some cases of refractory constipation in critically ill adults."( Neostigmine in the treatment of refractory constipation in critically ill children.
Botrán, M; García, A; González, R; López-Herce, J; Solana, MJ; Urbano, J, 2011
)
2.53
"Neostigmine has been found to cause peripheral analgesia. "( Can neostigmine reduce propofol injection pain?
Chang, DP; Mok, MS; Pang, WW; Wang, CS; Yeh, M, 2002
)
2.32
"Neostigmine has been added to local anesthetics for central and peripheral nerve blocks resulting in prolonged, increased anesthesia and improved analgesia. "( Intravenous regional anesthesia using prilocaine and neostigmine.
Karamanlýoglu, B; Kaya, G; Memis, D; Pamukçu, Z; Turan, A, 2002
)
2.01
"Neostigmine has been added to local anesthetics for central and peripheral nerve blocks. "( Intravenous regional anesthesia using prilocaine and neostigmine.
Karamanlýoglu, B; Kaya, G; Memis, D; Pamukçu, Z; Turan, A, 2002
)
2.01
"Neostigmine has been proposed as an effective treatment for ACPO as an alternative to colonoscopic decompression."( Assessment of predictors of response to neostigmine for acute colonic pseudo-obstruction.
Baron, TH; Harewood, GC; Loftus, CG, 2002
)
1.3
"Neostigmine has been added to local anesthetics for different nerve blocks. "( Caudal ropivacaine and neostigmine in pediatric surgery.
Başaran, UN; Karamanlioğlu, B; Memiş, D; Süt, N; Turan, A, 2003
)
2.07
"Neostigmine has shown analgesic benefit when used as an adjunct to epidural or intrathecal anesthesia and analgesia, but evidence of benefit in the peripheral nervous system is controversial. "( No anesthetic or analgesic benefit of neostigmine 1 mg added to intravenous regional anesthesia with lidocaine 0.5% for hand surgery.
Brill, S; Chan, VW; Iagounova, A; McCartney, CJ; Rawson, R; Sanandaji, K,
)
1.85
"Neostigmine has the shortest elimination half-life, and edrophonium, pyridostigmine and ambenonium follow in that."( Comparative pharmacokinetics of four cholinesterase inhibitors in rats.
Iga, T; Sawada, Y; Yamamoto, K, 1995
)
1.01
"Neostigmine has a similar, although longer, effect."( Effect of edrophonium and neostigmine on the pharmacokinetics and neuromuscular effects of mivacurium.
Brown, R; Fisher, DM; Fogarty, D; Kirkegaard-Nielsen, H; Sharma, ML; Szenohradszky, J, 2000
)
1.33
"Neostigmine methylsulfate has a quaternary ammonium group, which prevents its penetration through the blood-brain barrier; hence its primary influence is believed to be due to its action on the peripheral nervous system."( A female with central anticholinergic syndrome responsive to neostigmine.
Francia, A; Parisi, P, 2000
)
1.27
"Neostigmine has been found to decrease lymphatic absorption in rats, presumably by causing constriction of the lymphatic stomata."( Effect of intraperitoneal neostigmine on peritoneal transport characteristics in CAPD.
Fortenbery, EJ; Hasbargen, BJ; Hasbargen, JA, 1992
)
1.31

Actions

Neostigmine and tramadol increase the probability for post-operative nausea or vomiting (PONV) It can produce analgesia by acting on the spinal cord.

ExcerptReferenceRelevance
"Neostigmine is known to increase gastrointestinal motility and has been used to treat gastrointestinal dysmotility after surgery."( Efficacy and safety of neostigmine on treating gastrointestinal dysmotility in severe acute pancreatitis patients: study protocol for a randomized controlled trial.
Du, T; Sheng, Y; Sun, H; Zhu, H, 2023
)
1.94
"Neostigmine can produce analgesia by acting on the spinal cord. "( Optimal single-dose epidural neostigmine for postoperative analgesia after partial hepatectomy.
Ge, SJ; Wang, B; Xue, ZG; Zhong, QS,
)
1.87
"Neostigmine and tramadol increase the probability for post-operative nausea or vomiting (PONV)."( Bayesian enhanced meta-analysis of post-operative analgesic efficacy of additives for caudal analgesia in children.
Engelman, E; Marsala, C, 2012
)
1.1
"IT neostigmine was found to suppress both leukocyte migration and MPO degranulation in a dose dependent manner."( Intrathecal neostigmine reduces the zymosan-induced inflammatory response in a mouse air pouch model via adrenomedullary activity: involvement of spinal muscarinic type 2 receptors.
Beitz, AJ; Han, HJ; Kang, SY; Kim, CY; Kim, HW; Kim, KW; Kwon, YB; Lee, JH; Roh, DH; Yang, IS; Yoon, SY, 2005
)
1.22
"Neostigmine produced an increase in TOF ratio in 52 patients and a decrease in 8."( Reversal of residual neuromuscular block with neostigmine at one to four hours after a single intubating dose of vecuronium.
Caldwell, JE, 1995
)
1.27
"Neostigmine may increase postoperative nausea and vomiting. "( Reversal of neuromuscular blockade with neostigmine has no effect on the incidence or severity of postoperative nausea and vomiting.
Halonen, P; Hovorka, J; Korttila, K; Nelskylä, K; Paatero, H; Sarvela, J; Soikkeli, A; Yli-Hankala, A, 1997
)
2.01
"neostigmine did cause significant side-effects and did not alter transport characteristics in CAPD patients."( Effect of intraperitoneal neostigmine on peritoneal transport characteristics in CAPD.
Fortenbery, EJ; Hasbargen, BJ; Hasbargen, JA, 1992
)
1.31
"5. Neostigmine did not cause obvious changes of the kinetics of IACh."( Effects of neostigmine and physostigmine on the acetylcholine receptor-ionophore complex in frog isolated sympathetic neurones.
Akaike, N; Sadoshima, J; Tokutomi, N, 1988
)
1.18
"Neostigmine may produce this effect by causing contractions of the gut musculature or by vasoconstriction of the blood vessels to the suture line, resulting in local ischaemia."( Effect of neostigmine on integrity of ileorectal anastomoses.
Bell, CM; Lewis, CB, 1968
)
1.37

Treatment

Pre-treatment with neostigmine blocked the effect of amylin when it was centrally injected. Pretreatment with nestigmine administered intravenously prevented the inhibitory effect of intracarotid atropine on the hypoglycemic response.

ExcerptReferenceRelevance
"Neostigmine treatment led to significant reduction of serum liver enzymes (LDH (47,147 ± 12,726 IU/l vs."( Pharmacologic cholinesterase inhibition improves survival in acetaminophen-induced acute liver failure in the mouse.
Eisenbach, C; Hoyler, B; Mogler, C; Sandig, C; Steinebrunner, N; Stremmel, W; Vittas, S, 2014
)
1.12
"Neostigmine treatment was required for 1 patient in the intensive care unit setting, and 3 patients were managed conservatively without complications."( The Potentially Fatal Ogilvie's Syndrome in Lateral Transpsoas Access Surgery: A Multi-Institutional Experience with 2930 Patients.
Beckman, JM; Januszewski, J; Kanter, AS; Keem, SK; Oskuian, RJ; Smith, W; Taylor, W; Uribe, JS, 2017
)
1.18
"Neostigmine is a treatment option for colonic pseudoobstruction. "( Use of neostigmine to relieve a suspected colonic pseudoobstruction in pregnancy.
Rausch, ME; Rosen, T; Troiano, NH, 2007
)
2.24
"Neostigmine treatment in rats that had fully recovered from NB based on the train-of-four ratio caused dose-dependent decreases in genioglossus electromyogram (to 70.3 +/- 7.6, 49.2 +/- 3.2, and 39.7 +/- 2.3% of control, respectively), decreases in diaphragm electromyogram (to 103.1 +/- 6.5, 83.1 +/- 4.7, and 68.7 +/- 7.3% of control), and decreases in minute ventilation to a nadir value of 79.6 +/- 6% of preneostigmine baseline. "( Unwarranted administration of acetylcholinesterase inhibitors can impair genioglossus and diaphragm muscle function.
Chamberlin, NL; Eikermann, M; Fassbender, P; Gautam, S; Jordan, AS; Kubo, S; Malhotra, A; Takahashi, M; White, DP, 2007
)
1.78
"Neostigmine-treated animals were also more sensitive than control to the hypothermic effect induced by oxotremorine."( Muscarinic receptor alterations following neostigmine treatment.
Costa, LG; Murphy, SD; Schwab, BW, 1982
)
1.25
"Neostigmine pretreatment 20 minutes before dosing potentiated clonidine's dose response (ED50 was reduced to 6.8 +/- 2.3 micrograms), but had no effect on dexmedetomidine (ED50 27 +/- 6.1 micrograms)."( Subarachnoid neostigmine potentiation of alpha 2-adrenergic agonist analgesia. Dexmedetomidine versus Clonidine.
Bouaziz, H; Eisenach, JC; Hewitt, C,
)
1.22
"Neostigmine treatment had no effect on either sow or pig venous blood gases."( Effect of oxygen and neostigmine on stillbirth and pig viability.
Hacker, RR; Zaleski, HM, 1993
)
1.33
"Neostigmine-treated animals examined between 6 to 72 hours after discontinuation of neostigmine therapy showed impaired response to the facilitating influence of guanidine."( Neostigmine methylsulfate. Does it have a chronic effect as well as a transient one?
Forbes, MS; Johns, TR; Ward, MD, 1975
)
2.42
"In neostigmine-pretreated animals, however, doses between 12.5 and 90 mg/kg could entirely abolish the anticholinesterase-induced twitch augmentation."( Corticosteroids and neuromuscular transmission: electrophysiological investigation of the effects of prednisolone on normal and anticholinesterase-treated neuromuscular junction.
Birnberger, KL; Dengler, R; Rüdel, R; Warelas, J, 1979
)
0.77
"Pretreatment with neostigmine completely prevented the clonidine-induced attenuation of the hypercapnic cerebral vasodilation attenuated by intrathecal clonidine (16% +/- 7%, 15% +/- 6%, 12% +/- 6%, and 16% +/- 8%, respectively)."( Intrathecal neostigmine prevents intrathecal clonidine from attenuating hypercapnic cerebral vasodilation in rabbits.
Dohi, S; Iida, H; Iida, M; Kumazawa, M; Sumi, K; Takenaka, M; Tanahashi, S, 2005
)
1.03
"Treatment with neostigmine and calcium pantothenate did not accelerate the recovery of the migrating myoelectrical complex, but promoted the recovery of the general intensity of action potential generation in the stomach and small intestine."( Role of activation of cholinergic influences in recovery of electrical activity of the stomach and small intestine during the early postoperative period in rats.
Popova, TS; Solov'yova, GI; Tropskaya, NS, 2007
)
0.68
"Pre-treatment with neostigmine blocked the effect of amylin when it was centrally injected, while the effect of amylin given peripherally was partially reduced."( Amylin given by central or peripheral routes decreases gastric emptying and intestinal transit in the rat.
Amico-Roxas, M; Caruso, A; Clementi, G; Cutuli, VM; de Bernardis, E; Prato, A, 1996
)
0.61
"Pretreatment with neostigmine administered intravenously prevented the inhibitory effect of intracarotid atropine on the hypoglycemic response that followed intracarotid insulin injection."( Neuropharmacological characterization of insulin-sensitive CNS glucoregulator.
Szabo, AJ; Szabo, O, 1975
)
0.58
"Treatment with neostigmine and atropine initially provided control."( Myasthenia gravis in a Fox Terrier litter.
Jenkins, WL; McDonald, CB; van Dyk, E, 1976
)
0.6
"Pretreatment with neostigmine or collagenase partially antagonized the initial effects without affecting the steady state effects of DMAE, indicating that the initial effects of DMAE may be, at least in part, due to inhibition of the enzyme acetylcholinesterase."( Endplate channel actions of a hemicholinium-3 analog, DMAE.
Alkadhi, KA, 1986
)
0.59
"Pretreatment with neostigmine and physostigmine did not enhance IACh at any concentrations, suggesting that AChE activity had already disappeared during the enzymatic treatment of the preparation."( Effects of neostigmine and physostigmine on the acetylcholine receptor-ionophore complex in frog isolated sympathetic neurones.
Akaike, N; Sadoshima, J; Tokutomi, N, 1988
)
0.99

Toxicity

Neostigmine has good efficacy in the decompression of pseudo-obstruction but is hindered by its wide side effect profile. The incidence and severity of these adverse events from intrathecal nestigmine appears to be affected by dose, method of administration, and baricity of solution.

ExcerptReferenceRelevance
" Mouse toxicity studies (LD50) indicate that 2 is approximately as toxic as HC-3 (1), whereas 3, 4, and 5 are 14."( Synthesis and structure-toxicity relationships of three new stable analogues of acetyl-seco-hemicholinium-3.
Charles, HC; Chihal, DM; Domer, FR; Haarstad, VB; Rege, AB, 1976
)
0.26
"A simplified, safe and flexible technique of anesthesia, based on a limited number of relatively cheap drugs, and allowing ventilation with air, was applied to 60 patients undergoing operations of at least 60 minutes' duration."( A simple, cheap, effective and safe procedure for general anesthesia.
Lelkens, JP, 1976
)
0.26
" HC-3 increased the LD50 values for both physostigmine and neostigmine but did not alter the effect on brain ACh levels produced by these agents."( Antagonism of acute physostigmine and neostigmine toxicity in mice by hemicholinium-3.
Freeman, JJ; Kosh, JW; Lin, J, 1987
)
0.79
" This suggested a predominantly central site for the toxic interaction."( Synergism of the toxicity of physostigmine and neostigmine by lithium or by a reserpine-like agent (Ro4-1284).
Davis, WM; Hatoum, NS, 1980
)
0.52
"The incidence and severity of these adverse events from intrathecal neostigmine appears to be affected by dose, method of administration, and baricity of solution."( Phase I safety assessment of intrathecal neostigmine methylsulfate in humans.
Eisenach, JC; Hood, DD; Tuttle, R, 1995
)
0.79
"We report the analgesic and adverse effects of intrathecally administered hyperbaric neostigmine, alone or combined with morphine, in two patients suffering from severe lower limb ischaemic pain (group 1), five patients undergoing Caesarean section (group 2) and 19 patients scheduled for orthopaedic surgery (group 3) under spinal anaesthesia."( Analgesic and adverse effects of a low dose of intrathecally administered hyperbaric neostigmine alone or combined with morphine in patients submitted to spinal anaesthesia: pilot studies.
Garcia, LV; Klamt, JG; Prado, WA, 1999
)
0.75
" No adverse effects or complications were noted."( Neostigmine: safe and effective treatment for acute colonic pseudo-obstruction.
Church, JM; Hyman, NH; Trevisani, GT, 2000
)
1.75
" We have shown that neostigmine is a safe and effective treatment for acute colonic pseudo-obstruction."( Neostigmine: safe and effective treatment for acute colonic pseudo-obstruction.
Church, JM; Hyman, NH; Trevisani, GT, 2000
)
2.07
"The oral LD50 of crude Entada phaseoloides, No."( [Study on acute toxicity and animal gastrointestinal activity of crude and processed products of Entada phaseoloides].
Deng, XK; Mei, ZN; Xiao, E; Xiong, H; Zhao, YH, 2010
)
0.36
" Neostigmine appears to be an effective and safe treatment option for ACPO patients with renal failure."( Effective and Safe Use of Neostigmine in Treatment of Acute Kidney Injury Associated with Colonic Pseudo-obstruction after Cardiac Surgery.
Min, YW; Pyo, JH; Rhee, PL, 2016
)
1.64
" Two reviewers independently selected the trials; extracted data on reversal times, incomplete reversals of NMB, and adverse events (AEs); and assessed the trials' methodological quality and evidence level."( Efficacy and safety of sugammadex compared to neostigmine for reversal of neuromuscular blockade: a meta-analysis of randomized controlled trials.
Carron, M; Ori, C; Tellaroli, P; Zarantonello, F, 2016
)
0.69
" Incidences of any drug-related adverse events were secondary outcomes."( The efficacy and safety of sugammadex for reversing postoperative residual neuromuscular blockade in pediatric patients: A systematic review.
Fan, L; Liu, G; Wang, R; Wang, T; Xue, J; Yan, Y, 2017
)
0.46
" Neostigmine has good efficacy in the decompression of pseudo-obstruction but is hindered by its wide side effect profile."( Neostigmine and glycopyrronium: a potential safe alternative for patients with pseudo-obstruction without access to conventional methods of decompression.
Adiamah, A; Ho, A; Johnson, S; Orbell, J, 2017
)
2.81
"9; and risk of composite adverse and serious adverse events."( The comparative efficacy and safety of sugammadex and neostigmine in reversing neuromuscular blockade in adults. A Cochrane systematic review with meta-analysis and trial sequential analysis.
Afshari, A; Allingstrup, M; Duch, P; Hristovska, AM, 2018
)
0.73
"Neostigmine is traditionally administered intravenously for treatment of acute colonic pseudo-obstruction (ACPO), though use is associated with administration constraints and adverse effects."( Efficacy and Safety of Subcutaneous Neostigmine for Ileus, Acute Colonic Pseudo-obstruction, or Refractory Constipation.
Campbell, ME; Grant, M; Greenland, M; Kram, B; Sommer, C; Wells, C, 2018
)
2.2
"To evaluate whether an alternative route of administration for neostigmine via subcutaneous (SQ) delivery is safe and effective in a broad cohort of medical and surgical patients."( Efficacy and Safety of Subcutaneous Neostigmine for Ileus, Acute Colonic Pseudo-obstruction, or Refractory Constipation.
Campbell, ME; Grant, M; Greenland, M; Kram, B; Sommer, C; Wells, C, 2018
)
1
"65%) experienced an adverse drug event leading to drug discontinuation, with 2 developing bradycardia that resolved with drug discontinuation alone."( Efficacy and Safety of Subcutaneous Neostigmine for Ileus, Acute Colonic Pseudo-obstruction, or Refractory Constipation.
Campbell, ME; Grant, M; Greenland, M; Kram, B; Sommer, C; Wells, C, 2018
)
0.76
" Despite the low incidence of adverse drug events observed, monitoring for bradycardia with telemetry may be considered."( Efficacy and Safety of Subcutaneous Neostigmine for Ileus, Acute Colonic Pseudo-obstruction, or Refractory Constipation.
Campbell, ME; Grant, M; Greenland, M; Kram, B; Sommer, C; Wells, C, 2018
)
0.76
" Subcutaneous neostigmine has the potential to minimize adverse cardiovascular effects while maintaining efficacy."( Subcutaneous neostigmine appears safe and effective for acute colonic pseudo-obstruction (Ogilvie's syndrome).
Frankel, A; Gillespie, C; Hewett, P; Lu, CT; Wattchow, D, 2019
)
1.24
"Subcutaneous neostigmine appears to be safe for the treatment of ACPO."( Subcutaneous neostigmine appears safe and effective for acute colonic pseudo-obstruction (Ogilvie's syndrome).
Frankel, A; Gillespie, C; Hewett, P; Lu, CT; Wattchow, D, 2019
)
1.25
" Data describing its use in the pediatric population are limited, and no large-scale studies are available evaluating the occurrence of adverse event across the full spectrum of ages."( Retrospective Analysis of the Safety and Efficacy of Sugammadex Versus Neostigmine for the Reversal of Neuromuscular Blockade in Children.
Brenn, BR; Donahue, BS; Gartley, A; Gaver, RS, 2019
)
0.75
" From subsequent chart review, we quantified occurrence of adverse events and administration of medications to treat adverse events."( Retrospective Analysis of the Safety and Efficacy of Sugammadex Versus Neostigmine for the Reversal of Neuromuscular Blockade in Children.
Brenn, BR; Donahue, BS; Gartley, A; Gaver, RS, 2019
)
0.75
" No other adverse events measured were found to be different between treatment groups."( Retrospective Analysis of the Safety and Efficacy of Sugammadex Versus Neostigmine for the Reversal of Neuromuscular Blockade in Children.
Brenn, BR; Donahue, BS; Gartley, A; Gaver, RS, 2019
)
0.75
"This study provides data supporting the safe and effective use of sugammadex for reversal of neuromuscular blockade throughout the entire range of ages in the pediatric population."( Retrospective Analysis of the Safety and Efficacy of Sugammadex Versus Neostigmine for the Reversal of Neuromuscular Blockade in Children.
Brenn, BR; Donahue, BS; Gartley, A; Gaver, RS, 2019
)
0.75
" Specifically, this study assessed the impact of sugammadex on cardiac adverse events (AEs) and other prespecified AEs of clinical interest."( A randomized trial evaluating the safety profile of sugammadex in high surgical risk ASA physical class 3 or 4 participants.
Blobner, M; Broussard, DM; Herring, WJ; Lin, L; Lombard, JF; Lutkiewicz, J; Mukai, Y; Wang, A; Watkins, M, 2021
)
0.62
"02; I2=76%] and overall adverse events [RR =0."( Effects and safety of neostigmine for postoperative recovery of gastrointestinal function: a systematic review and meta-analysis.
Li, Y; Liao, Y; Ouyang, W, 2021
)
0.94
" The most common individual side effect was bradycardia (2."( Sugammadex Versus Neostigmine for Reversal of Residual Neuromuscular Blocks After Surgery: A Retrospective Cohort Analysis of Postoperative Side Effects.
Chahar, P; Chhabada, S; Khanna, S; Li, K; Maheshwari, K; Ruetzler, K; Schmidt, MT; Sessler, DI; Turan, A; Yang, D, 2022
)
1.06
" Sugammadex exhibits advantages over indirect reversal agent acetylcholinesterase inhibitor neostigmine with less adverse effects."( Sugammadex reversal of muscle relaxant blockade provided less Post-Anesthesia Care Unit adverse effects than neostigmine/glycopyrrolate.
Chang, HC; Lee, MJ; Lee, SO; Liu, SY; Wong, CS, 2022
)
1.15
" CONCLUSIONS Sugammadex administration is safe and effective for SPK transplantation recipients."( Safety and Efficacy of 4 mg·kg⁻¹ Sugammadex for Simultaneous Pancreas-Kidney Transplantation Recipients: A Prospective Randomized Trial.
He, R; Tang, J; Xu, S; Zhang, L, 2023
)
0.91

Pharmacokinetics

Parathion and its active metabolite, paraoxon, were investigated after intravenous administration of parathion, 3 mg/kg. Except for a longer distribution half-life, the pharmacokinetic variables for edrophonium did not differ significantly from those for neostigmine.

ExcerptReferenceRelevance
" The fast disposition (distribution) half-life of the drug was invariably less than 1 min; the slow disposition (elimination) half-life ranged from 15."( Pharmacokinetics and pharmacological effects of neostigmine in man.
Calvey, TN; Chan, K; Wareing, M; Williams, NE, 1979
)
0.52
" 3 The apparent volume of distribution of pyridostigmine was invariably greater than that of neostigmine, and its fast disposition half-life was approximately three times longer."( Plasma clearance of neostigmine and pyridostigmine in the dog.
Baker, PR; Calvey, TN; Chan, K; Macnee, CM; Taylor, K, 1978
)
0.8
" Only in the last few years, since the introduction of highly sensitive and selective analytical procedures based on gas and liquid chromatography, have proper pharmacokinetic studies of these drugs become possible."( Clinical pharmacokinetics of cholinesterase inhibitors.
Aquilonius, SM; Hartvig, P,
)
0.13
" Except for a longer distribution half-life, the pharmacokinetic variables for edrophonium did not differ significantly from those for neostigmine."( Pharmacokinetics of edrophonium and neostigmine when antagonizing d-tubocurarine neuromuscular blockade in man.
Cronnelly, R; Fahey, MR; Miller, RD; Morris, RB; Stanski, DR, 1981
)
0.74
" Pharmacokinetic analysis showed no significant differences for rocuronium during the 3 anesthetic techniques."( Clinical pharmacology of rocuronium (Org 9426): study of the time course of action, dose requirement, reversibility, and pharmacokinetics.
Hennis, PJ; Leclercq, MG; Smeulers, NJ; van den Broek, L; van Santen, GJ; Wierda, JM,
)
0.13
" A pharmacodynamic model was developed by considering acetylcholinesterase (AChE) inhibition, direct antagonism to the nicotinic receptor, and desensitization of the nicotinic receptor."( Pharmacodynamic analysis of contractile potentiation by cholinesterase inhibitors in rats.
Iga, T; Sawada, Y; Yamamoto, K, 1996
)
0.29
" Pharmacokinetic and pharmacodynamic analyses were performed with NONMEM."( Cerebrospinal fluid pharmacokinetics and pharmacodynamics of intrathecal neostigmine methylsulfate in humans.
Eisenach, JC; Hood, DD; Shafer, SL; Tong, C, 1998
)
0.53
" A three-compartment pharmacokinetic model was justified."( Antagonism of rapacuronium using edrophonium or neostigmine: pharmacodynamics and pharmacokinetics.
Danjoux, G; Hing, JP; Hunter, JM; Mills, KG; Pollard, BJ; Scott, JM; Wright, PM, 1999
)
0.56
" The pharmacokinetic changes of parathion and its active metabolite, paraoxon, were investigated after intravenous administration of parathion, 3 mg/kg, to control Sprague-Dawley rats and the rats pretreated with neostigmine (200 microg/kg, intraperitoneal injection 30 min before parathion administration)."( Effects of neostigmine on the pharmacokinetics of intravenous parathion in rats.
Hurh, E; Kim, SH; Kim, SY; Kim, YC; Kim, YG; Lee, EJ; Lee, MG, 2000
)
0.88
" The method was successfully applied to pharmacokinetic study of neostigmine methylsulfate injection in beagle dogs."( Development and validation of a rapid and high-sensitivity liquid chromatography-tandem mass spectrometry assay for the determination of neostigmine in small-volume beagle dog plasma and its application to a pharmacokinetic study.
Cao, D; Fan, G; Li, J; Li, W; Song, F; Sun, F; Ye, X; Zhao, X, 2014
)
0.84

Compound-Compound Interactions

Morphine alone or in combination with neostigmine provided effective postoperative analgesia in most dogs after orthopedic surgery.

ExcerptReferenceRelevance
"We report the analgesic and adverse effects of intrathecally administered hyperbaric neostigmine, alone or combined with morphine, in two patients suffering from severe lower limb ischaemic pain (group 1), five patients undergoing Caesarean section (group 2) and 19 patients scheduled for orthopaedic surgery (group 3) under spinal anaesthesia."( Analgesic and adverse effects of a low dose of intrathecally administered hyperbaric neostigmine alone or combined with morphine in patients submitted to spinal anaesthesia: pilot studies.
Garcia, LV; Klamt, JG; Prado, WA, 1999
)
0.75
"We previously found that spinal clonidine prolongs labor analgesia when combined with spinal bupivacaine and sufentanil."( Neostigmine combined with bupivacaine, clonidine, and sufentanil for spinal labor analgesia.
D'Angelo, R; Dean, LS; Meister, GC; Nelson, KE, 2001
)
1.75
"This study evaluated the efficacy of an epidural single dose of neostigmine combined with sufentanil to provide selective and balanced analgesia at the beginning of labor."( Epidural neostigmine combined with sufentanil provides balanced and selective analgesia in early labor.
Lavand'homme, PM; Roelants, F, 2004
)
0.98
" Epidural combination with neostigmine 250 micrograms was ineffective, whereas 750 micrograms did not produce higher effect than 500 micrograms."( Epidural neostigmine combined with sufentanil provides balanced and selective analgesia in early labor.
Lavand'homme, PM; Roelants, F, 2004
)
1.04
"To investigate the effects of penehyclidine hydrochloride(PH)/atropine combined with neostigmine for antagonizing residual neuromuscular block on the hemodynamics."( [Effects of penehyclidine hydrochloride or atropine combined with neostigmine for antagonizing residual neuromuscular block on patient's hemodynamics].
Chen, YM; Liang, SW, 2005
)
0.79
"To evaluate analgesic effects of epidurally administered neostigmine alone or in combination with morphine in dogs after ovariohysterectomy."( Postoperative analgesic effects of epidural administration of neostigmine alone or in combination with morphine in ovariohysterectomized dogs.
Hatschbach, E; Luna, SP; Marucio, RL; Minto, BW; Neto, FJ, 2008
)
0.83
"Electroacupuncture combined with acupoint injection has a satisfied therapeutic effect for treatment of EPISBO."( [Clinical observation on electroacupuncture combined with acupoint injection for treatment of early postoperative inflammatory intestinal obstruction].
Ding, KY; Guan, J; Shen, LP, 2010
)
0.36
"To evaluate the effectiveness and safety of epidural lidocaine in combination with either tramadol or neostigmine for perineal analgesia in horses."( Efficacy of epidural lidocaine combined with tramadol or neostigmine on perineal analgesia in the horse.
DeRossi, R; Maciel, FB; Módolo, TJ; Pagliosa, RC, 2013
)
0.85
" We aimed to determine the analgesic and adverse effects of intrathecal neostigmine combined with hyperbaric bupivacaine and fentanyl."( Analgesic effect of intrathecal neostigmine combined with bupivacaine and fentanyl.
Akinwale, MO; Akinyemi, OA; Sotunmbi, PT, 2012
)
0.89
"When administered epidurally, morphine alone or in combination with neostigmine provided effective postoperative analgesia in most dogs after orthopedic surgery, whereas neostigmine alone did not."( Postoperative analgesic effects of epidural administration of neostigmine alone or in combination with morphine in dogs undergoing orthopedic surgery of the pelvic limbs.
Fantoni, DT; Marucio, RL; Monteiro, ER; Moroz, LR, 2014
)
0.88
"To investigate the feasibility of using a revised major purgative decoction in combination with nasointestinal decompression for the treatment of intestinal paralysis."( Treatment of Intestinal Paralysis Using Revised Major Purgative Decoction Combined with Nasointestinal Decompression: Experience with 31 Patients.
Dechun, L; Guoqing, S; Hongtao, D; Ruihong, L; Wei, L, 2015
)
0.42
"Seventy-four patients undergoing TURBT were randomly allocated to receive either glycopyrrolate 10 μg/kg (glycopyrrolate group, n = 37) or atropine 15 μg/kg (atropine group, n = 37) in combination with neostigmine 25 μg/kg at the end of surgery for reversal of neuromuscular blockade."( Effect of glycopyrrolate versus atropine coadministered with neostigmine for reversal of rocuronium on postoperative catheter-related bladder discomfort in patients undergoing transurethral resection of bladder tumor: a prospective randomized study.
Kim, HC; Lim, SM; Park, HP; Seo, H, 2015
)
0.85

Bioavailability

No difference was observed between neostigmine and placebo for time to reach peak plasma acetaminophen concentration and absorption rate constant. The oral bioavailability of these hydrophilic ionised compounds is low.

ExcerptReferenceRelevance
"It is well known that the nasal route may be an effective alternative to the administration of drugs poorly absorbed via oral administration."( Pharmacokinetic study of neostigmine after intranasal and intravenous administration in the guinea pig.
Bandi, GL; Formenti, A; Fossati, A; Vimercati, MG, 1990
)
0.58
" atropine and pirenzepine) and the results were compared with the bioavailability (i."( The mean cumulative fraction absorbed-time profiles of paracetamol as an index of gastric emptying.
Meyer, EC; Moncrieff, J; Sommers, DK; van Wyk, M, 1990
)
0.28
" The oral bioavailability of these hydrophilic ionised compounds is low: that of pyridostigmine is approximately 10% and the value for neostigmine is even lower."( Clinical pharmacokinetics of cholinesterase inhibitors.
Aquilonius, SM; Hartvig, P,
)
0.33
"Antivenom in order to be effective in the treatment of coral snake accidents must be injected very soon after the bite owing to the rapid rate of absorption of the venom neurotoxins."( Neostigmine in the treatment of snake accidents caused by Micrurus frontalis: report of two cases (1).
Vieira, RJ; Vital Brazil, O,
)
1.57
"To study the pharmacokinetics and relative bioavailability of neostigmine bromide conventional tablets and sustained-release tablets in rabbits."( [Pharmacokinetics and relative bioavailability of neostigmine bromide sustained-release tablets].
Liu, BL; Luo, W; Tan, QY; Xiong, HR; Zhang, JQ, 2011
)
0.86
" The relative bioavailability of the neostigmine bromide sustained-release tablets was 115."( [Pharmacokinetics and relative bioavailability of neostigmine bromide sustained-release tablets].
Liu, BL; Luo, W; Tan, QY; Xiong, HR; Zhang, JQ, 2011
)
0.9
"No difference was observed between neostigmine and placebo for time to reach peak plasma acetaminophen concentration and absorption rate constant."( In vivo and in vitro effects of neostigmine on gastrointestinal tract motility of horses.
Harmon, FA; Morales, B; Nieto, JE; Snyder, JR; Stanley, SD; Yamout, SZ, 2013
)
0.95
" We hypothesized that the inhibition of cholinesterase activity might increase acetylcholine bioavailability and consequently cholinoceptor activation, leading to concomitant adenosine release from nerve endings and skeletal muscle fibers."( Paradoxical neostigmine-induced TOFfade: on the role of presynaptic cholinergic and adenosine receptors.
Alves-Do-Prado, W; Ambiel, CR; Antônio, MB; Correia-de-Sá, P; de Paula Ramos, E, 2014
)
0.78
" All compounds displayed favourable ADME findings which predict good oral bioavailability of these derivatives."( Quinoline containing chalcone derivatives as cholinesterase inhibitors and their in silico modeling studies.
Farooq Rizvi, SU; Iqbal, J; Najam-Ul-Haq, M; Shah, HS; Shah, MS, 2018
)
0.48

Dosage Studied

We have studied the dose-response relationships for neostigmine and edrophonium during antagonism of neuromuscular block induced by pipecuronium bromide. The results indicated that: 1) The effect of electroacupuncture analgesia can be enhanced by subcutaneous injection of neostIGmine which related to the dosage used. There was no clinically significant difference in median neostigsmine dosing based on last TOF count prior to reversal administration: 37.

ExcerptRelevanceReference
" It can be administered only subcutaneously or orally, and adequate dosage is necessary for a successful response."( Uropharmacology: v. choline esters and other parasympathomimetic drugs.
Bissada, NK; Finkbeiner, AE; Welch, LT, 1977
)
0.26
" Ronnel did not have an effect on ChE activity, whereas dichlorvos and cythioate, at all dosage levels, had an inhibitory effect."( Motor unit irritability in Beagles Before and after exposure to cholinesterase inhibitors.
Bowen, JM; Hazelwood, JC; Stefan, GE, 1979
)
0.26
" There was no evidence for saturation of the rate or the extent of sequestration of NEO or HPTMA over the dosage range examined."( Sequestration of neostigmine and metabolites by perfused rat liver.
Anderson, JH; Somani, SM,
)
0.47
" The latter dosage of this drug combination thus appears preferable in patients presenting for emergency surgery, if the integrity of the lower oesophageal sphincter is to be maintained during extubation and recovery from general anaesthesia."( Reversal of neuromuscular blockade by glycopyrrolate and neostigmine. A study of the effects on lower oesophageal sphincter tone.
Brock-Utne, JG,
)
0.38
" The latter dosage of this drug combination, therefore, appears preferable in patients presenting for emergency surgery if the integrity of the lower esophageal sphincter is to be maintained during extubation and recovery from general anesthesia."( Lower esophageal sphincter tone during reversal of neuromusclar blockade by atropine and neostigmine.
Brock-Utne, JG; Dimopoulos, GE; Downing, JW; Moshal, MG; Welman, S,
)
0.35
" All these compounds led to abnormalities of the cervical vertebrae; at higher dosage interference with normal morphogenesis involved the whole vertebral column."( Cholinomimetic teratogens: studies with chicken embryos.
Landauer, W, 1975
)
0.25
" Radical excision of the tumor, if possible, and the remaining thymus, high dosage alternate day prednisone, and radiation therapy, if indicated, seem the treatments of choice."( Myasthenia gravis and invasive thymoma: a 20-year experience.
Brown, WJ; Goldman, AJ; Herrmann, C; Keesey, JC; Mulder, DG, 1975
)
0.25
"We have studied the dose-response relationship for neostigmine in 36 adult (ages 18-50 yr) and 36 elderly (ages > 70 yr) subjects during antagonism of neuromuscular block induced by vecuronium."( Dose-response relationships for neostigmine antagonism of vecuronium-induced neuromuscular block in adults and the elderly.
Cooper, R; McCarthy, GJ; Mirakhur, RK; Stanley, JC, 1992
)
0.82
" Cumulative dose-response showed the ED95 to be 33."( Clinical evaluation of doxacurium chloride.
Clarke, RS; Cooper, R; Maddineni, VR; Mirakhur, RK; Stanley, JC, 1992
)
0.28
"The dose-response relationship of Org 9426, its time course of action and the reversibility of the residual block by neostigmine have been investigated in 100 patients undergoing various anaesthetic techniques."( Dose-response relationship and time course of action of Org 9426. A new muscle relaxant of intermediate duration evaluated under various anaesthetic techniques.
Agoston, S; De Wit, AP; Hennis, PJ; Lambalk, LM; Wierda, JM, 1991
)
0.49
" The results indicated that: 1) The effect of electroacupuncture analgesia can be enhanced by subcutaneous injection of neostigmine which related to the dosage used."( [Acetylcholine and the primary input of acupuncture sensation--influence of peripheral acetylcholine on the role of electroacupuncture analgesia].
Guan, X; Liang, X; Liu, X, 1990
)
0.49
" The dosing was either metoclopramide alone or combined with either neostigmine and pirenzepine or with neostigmine and atropine."( The effect of neostigmine on metoclopramide-induced aldosterone secretion after the administration of muscarinic antagonists in man.
Meyer, EC; Sommers, DK; van Wyk, M, 1990
)
0.88
" We examined the dose-response relation of pipecuronium in 27 patients, ages 66-79 years, utilizing the incremental dose method under balanced anesthesia."( A dose-response evaluation of pipecuronium bromide in elderly patients under balanced anesthesia.
Azad, SS; Beach, CA; Goldberg, ME; Larijani, GE; Marr, AT; Seltzer, JL, 1989
)
0.28
"To determine the potencies of edrophonium and neostigmine as antagonists of nondepolarizing neuromuscular blockade produced by atracurium and vecuronium, dose-response curves were constructed for both antagonists when given at 10% spontaneous recovery of first twitch height."( Dose-response relationships for edrophonium and neostigmine as antagonists of atracurium and vecuronium neuromuscular blockade.
Bevan, DR; Donati, F; Smith, CE, 1989
)
0.79
"The dose-response relationship and the doses of atropine required to prevent neostigmine from lowering heart rates below baseline in 50 per cent (ED50) and 95 percent (ED95) of patients after antagonism of pancuronium-induced neuromuscular blockade were determined in 70 patients with neostigmine-atropine mixtures."( Atropine-neostigmine mixture: a dose-response study.
Gomaa, M; Naguib, M, 1989
)
0.92
" Dosage of drugs influencing peristalsis is facilitated."( [Computer-assisted drug therapy of incomplete ileus].
Geissler, N; Heymann, H; Jung, D, 1989
)
0.28
" Our study revealed that both drugs have a strong effect on presynaptic sites and that these stimulating effects of edrophonium and neostigmine were about the same degree if 10 times as high a dosage as that of the former is used."( [The effect of neostigmine and edrophonium on the MEPP frequency].
Amaki, Y; Kaneko, M; Kobayashi, K, 1989
)
0.83
" Dose-response analyses of PAR recorded from muscle electrically and by contractile measurement disclose a loss of this pharmacologic responsiveness in myasthenia."( Motor nerve ending disorder in myasthenia gravis.
Riker, WF; Roe, RD; Standaert, FG, 1988
)
0.27
" With reduced dosage and with careful neuromuscular monitoring, vecuronium can be used safely in the myasthenic patient."( Vecuronium in the myasthenic patient.
Bell, CF; Florence, AM; Hunter, JM; Jones, RS; Utting, JE, 1985
)
0.27
"To measure the ability of neostigmine and edrophonium to reverse moderate and profound atracurium blockade, dose-response relationships were established for these reversal agents given at 1% and 10% twitch height recovery."( Dose-response relationships for edrophonium and neostigmine as antagonists of moderate and profound atracurium blockade.
Bevan, DR; Donati, F; Smith, CE, 1989
)
0.83
" Anticholinesterase medication (nine patients) and corticosteroid dosage (six patients) had been kept constant for a 2-month period."( Effects of repeated doses of intravenous immunoglobulin in myasthenia gravis.
Arsura, EL; Bick, A; Brunner, NG; Grob, D, 1988
)
0.27
" It was concluded that glycopyrrolate enhanced atracurium-induced neuromuscular blockade in the rat diaphragm preparation, and that this effect should be noted when dosing glycopyrrolate in man."( Glycopyrrolate intensifies neuromuscular blockade produced by atracurium in the rat diaphragm preparation.
Altinel, A; Dark, CH; Jones, CJ; Wali, FA, 1987
)
0.27
"To determine the potencies of neostigmine, pyridostigmine, and edrophonium in reversing pancuronium and d-tubocurarine blockade, dose-response curves were established for first twitch height recovery and train-of-four ratio."( Dose-response curves for edrophonium, neostigmine, and pyridostigmine after pancuronium and d-tubocurarine.
Antzaka, C; Bevan, DR; Donati, F; McCarroll, SM; McCready, D, 1987
)
0.83
" Concentrations of anticholinesterases spanned the clinical range and were extended beyond to establish dose-response curves."( Incomplete reversal of pancuronium neuromuscular blockade by neostigmine, pyridostigmine, and edrophonium.
Bartkowski, RR, 1987
)
0.51
" Dose-response relationships were established from the measurement of first twitch height (T1) ten minutes later."( Neostigmine, pyridostigmine and edrophonium as antagonists of deep pancuronium blockade.
Bevan, DR; Donati, F; Lahoud, J; McCready, D, 1987
)
1.72
" Joint application of ACh and CCh generated a dose-response profile consistent with a model of competitive antagonism between a full agonist (CCh) and a partial one (ACh)."( A study of the contractile response to acetylcholine in human ileal and detrusor muscle: origin of the low efficacy of acetylcholine.
Cohen, S; Nissenkorn, I; Rubinstein, R, 1986
)
0.27
" A dose-response relationship between neostigmine dose and the rate of/or total neural activity has been established in the rat."( Measurement of fasciculations as motor nerve ending discharges in the rat: a dose related effect of neostigmine.
Baker, T; Sprouse, JS, 1985
)
0.76
" It is suggested that the dosage of anticholinergic agents given with neostigmine could be reduced in elderly patients in comparison to that in younger patients."( Antagonism of neuromuscular block in the elderly. A comparison of atropine and glycopyrronium in a mixture with neostigmine.
Mirakhur, RK, 1985
)
0.71
" In reduced dosage and with careful neuromuscular monitoring, atracurium is safe to use in the myasthenic patient."( Atracurium in the myasthenic patient.
Bell, CF; Florence, AM; Hunter, JM; Jones, RS; Utting, JE, 1984
)
0.27
" The dose-response relationships for the antagonism of Org NC 45 and pancuronium neuromuscular blockades were not significantly different."( Antagonism of org NC 45 (vecuronium) and pancuronium neuromuscular blockade by neostigmine.
Gencarelli, PJ; Miller, RD, 1982
)
0.49
"The dose-response curves of vecuronium and pancuronium were compared during ketamine anaesthesia in 60 patients (ASA I)."( Dose-response relationships and neuromuscular blocking effects of vecuronium pancuronium during ketamine anaesthesia.
Engbaek, J; Ording, H; Pedersen, T; Viby-Mogensen, J, 1984
)
0.27
" Thus, the dose-response curve shows an U-shaped form."( The impairment of retention induced by beta-endorphin in mice may be mediated by a reduction of central cholinergic activity.
Baratti, CM; Introini, IB, 1984
)
0.27
" Accordingly, the dose-response relationship, onset and duration of action (n = 60), and pharmacokinetics (n = 22) of neostigmine, pyridostigmine, their metabolites 3-hydroxyphenyltrimethylammonium (PTMA) and 3-hydroxy-N-methylpyridinium (MP), and edrophonium were determined in dogs anesthetized with sodium pentobarbital."( Metabolites of neostigmine and pyridostigmine do not contribute to antagonism of neuromuscular blockade in the dog.
Cronnelly, R; Fisher, DM; Hennis, PJ; Miller, RD; Sharma, M, 1984
)
0.83
" No cardiovascular effects were observed in this dosage range."( Clinical pharmacology of atracurium besylate (BW 33A): a new non-depolarizing muscle relaxant.
Ali, HH; Basta, SJ; Cato, AE; Cloutier, G; Gionfriddo, M; Lineberry, C; Savarese, JJ; Sunder, N, 1982
)
0.26
" The degree of changes was shown to depend on acetylcholine dosage and animals' age."( [Effect of acetylcholine on cyclic guanosine monophosphate levels in the hearts of rats of different ages].
Kul'chitskiĭ, OK, 1980
)
0.26
" In the same preparation the dose-response curve of the potassium current induced by application of different concentrations of acetylcholine (ACh), the time constant of relaxation and the current fluctuations were measured."( On the kinetics of the potassium channel activated by acetylcholine in the S-A node of the rabbit heart.
Noma, A; Osterrieder, W; Trautwein, W, 1980
)
0.26
" Because the endplate potential (EPP) amplitude is a composite of pre- and post-junctional effects, the dose-response curve for neostigmine on EPP amplitude approximately paralleled that obtained on MEPP amplitude, whereas the effect of physostigmine on EPP amplitude was depressed because of its action to decrease transmitter release."( Further comparison of the effects of physostigmine and neostigmine on frog neuromuscular transmission.
Alderdice, MT,
)
0.58
" Ten other tests with half the dosage provoked fasciculations in eight cases (2-3 muscle groups on average)."( Neostigmine-induced fasciculations--a useful diagnostic test?
Heijnsbroek, GJ; van Gijn, J, 1983
)
1.71
" Patients treated with Ceruletide (n = 30, dosage of Ceruletide 2 ng/kg/min."( [Treatment of intestinal atony following gynecologic operations. Study on the effectiveness and tolerance of ceruletide].
Baur, M; Heinrich, D; Kubli, F; Schmid, H; Schulz-Wendtland, R; von Fournier, D, 1984
)
0.27
" A sigmoid dose-response curve was obtained for the phasic contraction."( Effect of sodium propionate on the contractile response of the rat ileum in situ.
Yajima, T, 1984
)
0.27
"The dose-response relationship, onset, duration of action, atropine requirement, and pharmacokinetic variables of edrophonium were determined in infants and children during N2O-halothane anesthesia."( Clinical pharmacology of edrophonium in infants and children.
Cronnelly, R; Fisher, DM; Miller, RD; Sharma, M, 1984
)
0.27
" All patients were evaluated from the standpoint of clinical response to thymectomy, and the number and dosage of anti-myasthenic drugs required after operation."( Cervical thymectomy in the treatment of myasthenia gravis.
Donnelly, RJ; Fabri, B; Florence, AM; Hayward, M; Laquaglia, MP, 1984
)
0.27
" The dose-response curve for the stimulating effect of neostigmine on saliva production was shifted to the right in borderline hypertensive as compared with normotensive subjects."( Studies of salivary flow in borderline hypertension: effects of drugs acting on structures innervated by the autonomic nervous system.
Rahn, KH; Schols, M; van Baak, MA; van Hooff, M, 1984
)
0.51
" Denervation changes in the muscle were evaluated using the resting membrane potential and dose-response curves obtained by plotting acetylcholine-induced contractures."( Effect of protein synthesis inhibitors on the trophic action of the nerve stump.
Higashimori, E; Komatsu, K; Satoh, S; Uchida, K, 1983
)
0.27
"We studied the effects of atropine (10(-10) to 10(-6) M), tetrodotoxin (TTX) (10(-6) g/ml), and neostigmine (10(-7) M) on the histamine dose-response curve of canine tracheal smooth muscle (TSM) in vitro."( Mechanisms of histamine-induced contraction of canine airway smooth muscle.
Irvin, CG; Martin, JG; Shenkier, T; Shore, S, 1983
)
0.48
" This confirms a previous report of a lethal synergism of physostigmine after subacute dosing with lithium."( Synergism of the toxicity of physostigmine and neostigmine by lithium or by a reserpine-like agent (Ro4-1284).
Davis, WM; Hatoum, NS, 1980
)
0.52
"1 The tetanic and single twitch responses to the adductor pollicis muscle were used to study the neuromuscular effects of repeated dosage of decamethonium in nine anaesthetized patients."( Tachyphylaxis after repeated dosage of decamethonium in anaesthetized man.
Al-Azawi, S; Hughes, R; Payne, JP, 1982
)
0.26
"In the light of studies on the duration of action and pharmacokinetics of intravenous neostigmine, it is recommended that, depending upon the dosage administered, at least 1 hour should elapse before a depolarizer can safely be given after neuromuscular reversal with neostigmine, and at least 90 - 120 minutes after reversal with physostigmine."( Administration of depolarizing muscle relaxants after non-depolarizer reversal: when is it safe?
De Roubaix, JA, 1982
)
0.49
" The dose-response curves of the frequency for acetylcholine were shifted to the right by atropine and to the left by neostigmine in both preparations."( Effects of acetylcholine on the tone and miniature contractions of isolated dog urinary bladder.
Ikegami, K; Mutoh, S; Sakanashi, M; Ueda, S; Yano, S, 1982
)
0.47
"125 mg/kg, however, the dose-response curve was not parallel to those for neostigmine or pyridostigmine."( Edrophonium: duration of action and atropine requirement in humans during halothane anesthesia.
Cronnelly, R; Miller, RD; Morris, RB, 1982
)
0.5
" Comparison of the results with those from 15 patients given suxamethonium 50 mg showed that atracurium in this dosage took longer to produce complete ablation of the twitch responses but that it lasted longer (about 40 min)."( Use of atracurium during general surgery monitored by the train-of-four stimuli.
Hunter, JM; Jones, RS; Utting, JE, 1982
)
0.26
"6 ng per ml) of a myasthenic patient over a period of twelve hours with repeated dosing of neostigmine bromide (30 mg) and pyridostigmine bromide (60 mg)."( The simultaneous monitoring of plasma levels of neostigmine and pyridostigmine in man.
Chan, K; Davison, SC; Dehghan, A; Hyman, N; Prentis, RA, 1980
)
0.74
" For the use of the equation, the parallel shift of the dose-response curve and the unchanged maximum response are prerequisites."( An extension of pA principle to the potentiation of drug effects, and its application to the biological assay of some anticholinesterases and cardenolides.
Ichikawa, T; Ishikawa, N; Shigei, T; Tsuru, H, 1980
)
0.26
" Neostigmine was injected either 20 or 60 minutes prior to beginning cumulative dosing with the alpha 2-adrenergic agonist."( Subarachnoid neostigmine potentiation of alpha 2-adrenergic agonist analgesia. Dexmedetomidine versus Clonidine.
Bouaziz, H; Eisenach, JC; Hewitt, C,
)
1.41
" The dose-response curve showed a U-shaped form."( The impairment of retention induced by insulin in mice may be mediated by a reduction in central cholinergic activity.
Baratti, CM; Kopf, SR, 1995
)
0.29
" The dose-response curves for neostigmine (10, 20, 30, and 40 micrograms/kg) were constructed using the TOFR values at 5-11 min, from which the ED50 values (a neostigmine dose required for a TOFR value of 50%) were derived."( Inadequate antagonism of vecuronium-induced neuromuscular block by neostigmine during sevoflurane or isoflurane anesthesia.
Fujita, T; Morita, T; Saito, S; Sato, H; Sugaya, T; Tsukagoshi, H, 1995
)
0.82
" We evaluated dose-response data and neuromuscular effects of 2 x ED95 dose and maintenance doses of 51W89 during halothane anaesthesia in 68 children, 2-12 yr old."( Pharmacodynamic effects of 51W89, an isomer of atracurium, in children during halothane anaesthesia.
Meretoja, OA; Taivainen, T; Wirtavuori, K, 1995
)
0.29
" We have studied 57 patients undergoing gynaecological surgery to establish a dose-response relationship when neostigmine was given to antagonize atracurium-induced block."( Optimum dose of neostigmine at two levels of atracurium-induced neuromuscular block.
Hall, IA; Harper, NJ; Wallace, M, 1994
)
0.85
" The dose-response relationships for neostigmine and edrophonium were studied during antagonism of neuromuscular block induced by rocuronium bromide."( Dose-response relationships for edrophonium and neostigmine antagonism of rocuronium bromide (ORG 9426)-induced neuromuscular blockade.
Abdulatif, M; al-Ghamdi, A; Naguib, M, 1993
)
0.81
"The dose-response curves for neostigmine- and edrophonium-assisted antagonism of rocuronium bromide neuromuscular blockade for the single twitch and TOF ratio were not parallel."( Dose-response relationships for edrophonium and neostigmine antagonism of rocuronium bromide (ORG 9426)-induced neuromuscular blockade.
Abdulatif, M; al-Ghamdi, A; Naguib, M, 1993
)
0.83
"We have studied the dose-response relationships for neostigmine and edrophonium during antagonism of neuromuscular block induced by mivacurium chloride."( Dose-response relationships for edrophonium and neostigmine antagonism of mivacurium-induced neuromuscular block.
Abdulatif, M; al-Ghamdi, A; Hamo, I; Naguib, M; Nouheid, R, 1993
)
0.79
"We have studied the dose-response relationships for neostigmine and edrophonium during antagonism of neuromuscular block induced by pipecuronium bromide."( Dose-response relationships for edrophonium and neostigmine antagonism of pipecuronium-induced neuromuscular block.
Abdulatif, M; Naguib, M, 1994
)
0.79
" It was concluded that bethanechol and, less likely, neostigmine at the dosage used in this study may be suitable for medical treatment of cecal dilatation in cattle in which hypomotility of the cecum and proximal loop of the ascending colon has to be reversed."( Effect of bethanechol, neostigmine, metoclopramide, and propranolol on myoelectric activity of the ileocecocolic area in cows.
Martig, J; Roussel, AJ; Steiner, A, 1995
)
0.85
" Thus, the dose-response curve adopted an inverted U-shaped form."( Effects of posttraining administration of glucose on retention of a habituation response in mice: participation of a central cholinergic mechanism.
Baratti, CM; Kopf, SR, 1996
)
0.29
" We have examined the dose-response relationships for neostigmine antagonism of 90% rocuronium-induced neuromuscular block in children and adults, during nitrous oxide-1 MAC of isoflurane anaesthesia."( Dose-response relationships for neostigmine antagonism of rocuronium-induced neuromuscular block in children and adults.
Abdulatif, M; al-Ghamdi, A; el-Sanabary, M; Mowafi, H, 1996
)
0.83
" administration decreased at high doses of each drug and the dose-response curves were biphasic."( Pharmacodynamic analysis of contractile potentiation by cholinesterase inhibitors in rats.
Iga, T; Sawada, Y; Yamamoto, K, 1996
)
0.29
"To establish a dose-response curve for the analgesic effect of intrathecal neostigmine in patients undergoing below knee surgery with spinal anesthesia."( Intrathecal neostigmine for postoperative analgesia after orthopedic surgery.
Lauretti, GR; Mattos, AL; Prado, WA; Reis, MP, 1997
)
0.91
") neostigmine has been developed to obtain a quicker onset of action and a more adaptable dosage regimen than oral neostigmine."( Intranasal versus intravenous neostigmine in myasthenia gravis: assessment by computer analysis of saccadic eye movements.
Benvenuti, C; Di Costanzo, A; Mannara, C; Tedeschi, G; Toriello, A, 1993
)
1.3
" Dose-response relations were assessed with analysis of variance, paired t tests, or Spearman rank correlation."( Dose-response effects of spinal neostigmine added to bupivacaine spinal anesthesia in volunteers.
Burkhead, DL; Hodgson, PS; Liu, SS; Moore, JM; Trautman, WJ, 1999
)
0.59
") elevated blood pressure to a plateau of 30-50 mm Hg above baseline level and shifted the dose-response curve for acetylcholine-induced responses to the right by about 70-fold."( Inhibitory mechanism of N(G)-nitro-L-arginine on acetylcholine-induced depressor responses in dogs.
Ishii, K; Nakahara, T; Nakayama, K; Nejishima, H, 1999
)
0.3
" Studies were carried out in control animals and after dosing with phenserine, a selective centrally active AChE inhibitor; neostigmine, a peripheral cholinesterase inhibitor; and a combination of the two drugs."( Simplified methods for in vivo measurement of acetylcholinesterase activity in rodent brain.
Kilbourn, MR; Sherman, PS; Snyder, SE, 1999
)
0.51
" Additionally, doses approximately double these ED50s each produced a similar duration of analgesia and side effects, indicating intrathecal neostigmine shifts the dose-response curve for intrathecal sufentanil to the left."( Intrathecal neostigmine and sufentanil for early labor analgesia.
D'Angelo, R; Eisenach, JC; Foss, ML; Hood, DD; Meister, GC; Nelson, KE, 1999
)
0.88
"3, 1, 3, and 10 microg) were administered intrathecally to obtain the dose-response curves and the 50% effective dose (ED(50)) for each drug."( An analysis of drug interaction between morphine and neostigmine in rats with nerve-ligation injury.
Choi, Y; Han, SM; Hwang, JH; Hwang, KS; Lee, DM; Park, PH, 2000
)
0.56
" Low dosage must be employed and repeated administration avoided."( Is vecuronium toxicity abolished by hemodialysis? A case report.
Borsa, S; Pignataro, A; Pozzato, M; Quarello, F; Rollino, C; Vallero, A; Visetti, E, 2000
)
0.31
"To study the dose-response relationships for neostigmine and edrophonium during antagonism of neuromuscular block induced by atracurium and cisatracurium."( Dose-response relationships for edrophonium and neostigmine antagonism of atracurium and cisatracurium-induced neuromuscular block.
Naguib, M; Riad, W, 2000
)
0.82
" NSM is a simple, safe, and effective treatment for ACPO and based on result comparison of this study and previous studies both bolus and slow infusion dosing practices of NSM are effective."( Retrospective study of neostigmine for the treatment of acute colonic pseudo-obstruction.
Abeyta, BJ; Albrecht, RM; Schermer, CR, 2001
)
0.62
" At this time the volatile agent administration was stopped or propofol dosage reduced in half the patients in each group (n = 20 in each group)."( Neostigmine antagonism of rocuronium block during anesthesia with sevoflurane, isoflurane or propofol.
Breslin, DS; Hayes, AH; Mirakhur, RK; Reid, JE, 2001
)
1.75
" We investigated the dose-response profile for the colonic sensorimotor effects of neostigmine and bethanechol, a direct muscarinic M(2)/M(3) agonist in humans."( Cholinergic stimulation enhances colonic motor activity, transit, and sensation in humans.
Bharucha, AE; Law, NM; Undale, AS; Zinsmeister, AR, 2001
)
0.54
"0 microg) were administered to obtain the dose-response curve and the 50% effective dose (ED(50))."( The interaction between intrathecal neostigmine and GABA receptor agonists in rats with nerve ligation Injury.
Choi, IC; Han, SM; Hwang, JH; Hwang, KS; Kim, JU; Park, PH, 2001
)
0.59
" This chapter updates current data on drug dose-response relationships for local anaesthetics and the increasing use of intrathecal adjuncts to improve the anaesthetic and recovery profile for ambulatory spinal anaesthesia."( Spinal anaesthesia: local anaesthetics and adjuncts in the ambulatory setting.
Liu, SS; Salinas, FV, 2002
)
0.31
"Although prokinetics are commonly used for management of POI in horses there is clearly a need for more controlled studies to define efficacious dosing and a need to develop new prokinetic drugs."( Survey of prokinetic use in horses with gastrointestinal injury.
Harmon, FA; Nieto, JE; Snyder, JR; Van Hoogmoed, LM,
)
0.13
" At this time, sevoflurane or the propofol dosage was reduced in each group (n = 20 in each group)."( Tactile assessment for the reversibility of rocuronium-induced neuromuscular blockade during propofol or sevoflurane anesthesia.
Cheong, MA; Kim, KS; Lee, HJ; Lee, JM, 2004
)
0.32
" Two groups had seven days of repeated dosing with either midazolam 100 microg/kg/day (repeat midazolam group) or 10 microg/kg/day neostigmine (repeat neostigmine group)."( The neurotoxic effects of intrathecal midazolam and neostigmine in rabbits.
Demirel, E; Dolgun, H; Egemen, N; Kahilogullari, G; Kecik, Y; Sargon, ME; Ugur, HC, 2006
)
0.79
"9 is slow in overweight and obese patients when vecuronium is dosed on the basis of the patient's RBW."( Neostigmine-induced reversal of vecuronium in normal weight, overweight and obese female patients.
Masaki, G; Ogawa, S; Suzuki, T, 2006
)
1.78
" Dose-response curves were constructed, and the effective concentration of the drug resulting in 50% of the maximal response (EC(50)) was identified."( Cutaneous blood flow and sweat rate responses to exogenous administration of acetylcholine and methacholine.
Crandall, CG; Davis, SL; Keller, DM; Kimura, K; Low, DA, 2007
)
0.34
"Adjuvants are compounds which by themselves have undesirable side-effects or low potency but in combination with opioids allow a reduction of narcotic dosing for postoperative pain control."( Useful adjuvants for postoperative pain management.
Buvanendran, A; Kroin, JS, 2007
)
0.34
"In the ileum, itopride accelerated peristaltic velocity at higher dosage (10(-10)-10(-6) M) whereas neostigmine accelerated it only with a lower dosage (10(-10)-10(-9) M)."( Effect of itopride hydrochloride on the ileal and colonic motility in guinea pig in vitro.
Kim, HS; Kim, YG; Lim, HC; Lim, JH; Park, H, 2008
)
0.56
" Opiate dosage consumed was also recorded as a primary outcome during the first 24 h following surgery."( Post-operative pain relief following intrathecal injection of acetylcholine esterase inhibitor during lumbar disc surgery: a prospective double blind randomized study.
Hamidi, S; Khan, ZH; Majedi, H; Miri, M; Nourijelyani, K, 2008
)
0.35
" Detailed pharmacologic dose-response curves of selected inhibitors were also measured in high-throughput fashion to validate the method."( Rapid and label-free screening of enzyme inhibitors using segmented flow electrospray ionization mass spectrometry.
Kennedy, RT; Li, Q; Pei, J, 2010
)
0.36
" Consequently, incorrect dosing will increase the rate of perioperative complications."( Perioperative pharmacology in morbid obesity.
Lemmens, HJ, 2010
)
0.36
" Total body weight dosing of neuromuscular blocking agents will result in a prolonged effect."( Perioperative pharmacology in morbid obesity.
Lemmens, HJ, 2010
)
0.36
"For the induction dose of hypnotics and the initial dose of other drugs that have a fast onset of effect, cardiac output or LBW are relevant dosing scalars."( Perioperative pharmacology in morbid obesity.
Lemmens, HJ, 2010
)
0.36
" The dose-response relationship was analyzed with a biexponential model using the dose as the independent variable and the logarithm of the recovery time as the dependent variable."( Sugammadex and neostigmine dose-finding study for reversal of shallow residual neuromuscular block.
Blobner, M; Fink, H; Schaller, SJ; Ulm, K, 2010
)
0.71
" Acetylcholinesterase inhibitors provide temporary symptomatic treatment of muscle weakness, but there is controversy about their long-term efficacy, dosage and side effects."( Acetylcholinesterase inhibitor treatment for myasthenia gravis.
Kuntzer, T; Mehndiratta, MM; Pandey, S, 2011
)
0.37
"A novel, simple, rapid, selective and sensitive method for the determination of neostigmine (Ns) ion in its bulk powder, different pharmaceutical dosage forms, and biological fluids (plasma and urine) using four modified carbon paste electrodes was developed."( Modified carbon paste sensor for the potentiometric determination of neostigmine bromide in pharmaceutical formulations, human plasma and urine.
Issa, YM; Khorshid, AF, 2014
)
0.86
"The management of neuromuscular blocks in day case surgery requests a comprehensive approach that should include an adequate dosing of the muscle relaxant, quantitative objective monitoring, and a sufficient and appropriate reversal."( Management of neuromuscular blockade in ambulatory patients.
Schreiber, JU, 2014
)
0.4
" Acetylcholinesterase inhibitors provide temporary symptomatic treatment of muscle weakness but there is controversy about their long-term efficacy, dosage and side effects."( Acetylcholinesterase inhibitor treatment for myasthenia gravis.
Kuntzer, T; Mehndiratta, MM; Pandey, S, 2014
)
0.4
"Adult patients undergoing abdominal surgery received rocuronium, followed by randomized allocation to sugammadex (2 or 4 mg kg(-1)) or usual care (neostigmine/glycopyrrolate, dosing per usual care practice) for reversal of neuromuscular blockade."( Effects of sugammadex on incidence of postoperative residual neuromuscular blockade: a randomized, controlled study.
Brueckmann, B; de Bie, J; Eikermann, M; Grobara, P; Kwo, J; Lee, J; Li, MK; Maktabi, M; McGovern, F; Pino, R; Sabouri, AS; Sasaki, N; Staehr-Rye, AK; Woo, T, 2015
)
0.62
"The dose-response relationship of drugs to reverse vecuronium-, rocuronium-, and cisatracurium-induced neuromuscular block (NMB) was evaluated in vitro (competition binding assays and urine analysis), ex vivo (n = 34; phrenic nerve hemidiaphragm preparation), and in vivo (n = 108; quadriceps femoris muscle of the rat)."( Comparative Effectiveness of Calabadion and Sugammadex to Reverse Non-depolarizing Neuromuscular-blocking Agents.
Ayata, C; Blobner, M; Diaz-Gil, D; Eikermann, M; Eikermann-Haerter, K; Foerster, U; Ganapati, S; Haerter, F; Isaacs, L; Moreno Duarte, I; Simons, JC; Zhang, B, 2015
)
0.42
"The aim of this dose-finding study was to evaluate the dose-response relationship of sugammadex and neostigmine to reverse a commonly observed level of incomplete recovery from rocuronium-induced neuromuscular block, that is, a train-of-four ratio (TOFR) ≥0."( Sugammadex and neostigmine dose-finding study for reversal of residual neuromuscular block at a train-of-four ratio of 0.2 (SUNDRO20)†,.
Baumüller, E; Blobner, M; Fink, H; Kaufhold, N; Schaller, SJ; Stäuble, CG; Ulm, K, 2016
)
1
" We also examined if dosing regimens reflect current practice guidelines of using ideal body weight (IBW) for NMB agents and total body weight (TBW) for neostigmine."( Observational study on patterns of neuromuscular blockade reversal.
Devine, S; Dubovoy, T; Housey, M; Kheterpal, S, 2016
)
0.63
" Secondary analyses evaluated associations between NMB dosing and neostigmine administration based on Body Mass Index (BMI) categories."( Observational study on patterns of neuromuscular blockade reversal.
Devine, S; Dubovoy, T; Housey, M; Kheterpal, S, 2016
)
0.67
" There was no clinically significant difference in median neostigmine dosing based on last TOF count prior to reversal administration: 37."( Observational study on patterns of neuromuscular blockade reversal.
Devine, S; Dubovoy, T; Housey, M; Kheterpal, S, 2016
)
0.68
"Neither neostigmine dosing nor times to extubation were affected by the depth of the neuromuscular blockade prior to reversal."( Observational study on patterns of neuromuscular blockade reversal.
Devine, S; Dubovoy, T; Housey, M; Kheterpal, S, 2016
)
0.87
" Here we review multiple studies from 1972 through 1986 that used varying methods of patient selection and dosage and drug combination criteria, and which noted that glycopyrrolate had a superior efficacy and adverse effect profile when compared with atropine in NMB reversal."( Glycopyrrolate: It's time to review.
D'mello, J; Howard, J; Rosen, G; Wigley, J, 2017
)
0.46
"Inappropriate dosing of neostigmine for antagonism of neuromuscular blockade has been associated with postoperative pulmonary complications."( Implementation of a new strategy to improve the peri-operative management of neuromuscular blockade and its effects on postoperative pulmonary complications.
Agarwala, AV; Chitilian, HV; Doney, AB; Eikermann, M; Houle, TT; Ng, PY; Ramachandran, SK; Rudolph, MI; Timm, FP, 2018
)
0.79
" We tested whether a protocol for the management of neuromuscular block that specified appropriate dosing and optimal neostigmine reversal was associated with a reduction in postoperative residual neuromuscular block."( Management of rocuronium neuromuscular block using a protocol for qualitative monitoring and reversal with neostigmine.
Bhananker, SM; Cain, KC; Ng, IC; Thilen, SR; Treggiari, MM, 2018
)
0.9
" The goal of our study was to investigate the real-world practice pattern of dosing of neuromuscular blocking agents (NMBA), utilizing the amount of NMBA used during the course of a case, adjusted for patient weight and case duration, as a surrogate measure of depth of NMB."( Investigation of intraoperative dosing patterns of neuromuscular blocking agents.
Beutler, SS; Gimlich, R; Palsen, S; Urman, RD; Wu, A; Yang, HK, 2019
)
0.51
"Improved understanding of the monitoring and dosing practices of anesthesia providers regarding neuromuscular blockade is necessary."( Evaluating a Quality Improvement Initiative to Increase Anesthesia Providers' Use of and Understanding of Quantitative Neuromuscular Monitors.
Bedsworth, MB; Goode, VM; Grant, SA; Harris, EM; Thompson, JA; Vacchiano, CA, 2019
)
0.51
" Peripherally acting acetylcholinesterase inhibitors such as neostigmine should then only be administered when indicated and dosed based on results of the train-of-four ratio."( The effects of acetylcholinesterase inhibitors on morbidity after general anesthesia and surgery.
Eikermann, M; Schaefer, MS; Shay, D; Wongtangman, K, 2020
)
0.8
" The aim of this clinical investigation was to assess the incidence of postoperative residual neuromuscular blockade in adult thoracic surgical patients administered neostigmine or sugammadex when optimal dosing and reversal strategies for these agents were used."( Neuromuscular and Clinical Recovery in Thoracic Surgical Patients Reversed With Neostigmine or Sugammadex.
Avram, MJ; Benson, J; Bilimoria, S; Greenberg, SB; Maher, CE; Murphy, GS; Szokol, JW; Teister, KJ, 2021
)
1.04
" It is not known whether there is a dose-dependent relationship between the dosage of calcium gluconate and the probability of transmitter release for non-depolarizing neuromuscular blockade (NMB) recovery by acetylcholinesterase inhibitors (AchEIs)."( Comparison of neuromuscular blockade recovery co-administered with neostigmine and different doses of calcium gluconate: a randomized control trial.
Choi, SR; Kim, JH; Lee, KH; Park, SY, 2021
)
0.86
"The aim of this study was to determine whether use of acceleromyography (1) changes dosing of neuromuscular blocking agents (NMBAs), and (2) increases the time between neostigmine administration and extubation, when compared with subjective assessment of neuromuscular blockade."( Vigilance: the behavioral impact of quantitative monitoring on administration and antagonism of neuromuscular blocking agents.
Grivoyannis, AD; Lien, CA; Tangel, V, 2022
)
0.92
" Introduction of neuromuscular blockade assessment appeared to increase provider vigilance in dosing of NMBAs-regardless of assessment method."( Vigilance: the behavioral impact of quantitative monitoring on administration and antagonism of neuromuscular blocking agents.
Grivoyannis, AD; Lien, CA; Tangel, V, 2022
)
0.72
"Due to excessive sugammadex expenditures at our institution, we designed dosing guidelines that utilize adjusted body weight and informatics-based tools aimed at reducing variability in dosing practices."( Use of provider education, intra-operative decision support, and an email-feedback system in improving compliance with sugammadex dosage guideline and reducing drug expenditures.
Clifton, JC; Gupta, RK; Pregnall, AM; Wanderer, JP, 2022
)
0.72
"Academic medical center in the United States - Vanderbilt University Medical Center (VUMC) PATIENTS: N/A INTERVENTIONS: First, anesthesia providers were educated on adjusted body weight-based dosing guidelines."( Use of provider education, intra-operative decision support, and an email-feedback system in improving compliance with sugammadex dosage guideline and reducing drug expenditures.
Clifton, JC; Gupta, RK; Pregnall, AM; Wanderer, JP, 2022
)
0.72
"38%) in sugammadex dosing practices after provider education and the implementation of digital improvement initiatives but failed to reveal a significant change after implementation of the email-feedback system."( Use of provider education, intra-operative decision support, and an email-feedback system in improving compliance with sugammadex dosage guideline and reducing drug expenditures.
Clifton, JC; Gupta, RK; Pregnall, AM; Wanderer, JP, 2022
)
0.72
" Inappropriate dosing of neostigmine can lead to post-operative respiratory complications."( Identifying high dose neostigmine as a risk factor for post-operative respiratory complications: a case-control study.
Al-Zarah, M; Drzymalski, DM; Hall III, RR; Quraishi, SA; Ranjan, S, 2021
)
1.24
" Our study suggests that inappropriate dosing of neostigmine continues to be a problem despite growing evidence of an association with respiratory complications."( Identifying high dose neostigmine as a risk factor for post-operative respiratory complications: a case-control study.
Al-Zarah, M; Drzymalski, DM; Hall III, RR; Quraishi, SA; Ranjan, S, 2021
)
1.19
"The use of a protocol that specifies rocuronium dosing and selective use of sugammadex versus neostigmine based on qualitative assessment of TOF count and fade allowed us to achieve an incidence of PRNB of 3% (95% CI, 1-7) at PACU arrival."( Evaluation of a Protocol for the Management of Maintenance and Reversal of Rocuronium Block Using Neostigmine or Sugammadex.
Bhananker, SM; Cain, KC; Kruse, TN; Liang, T; Thilen, SR; Treggiari, MM, 2023
)
1.35
"To compare the optimal dosage and safety of neostigmine for reversing shallow residual block in elderly patients after cisatracurium-induced neuromuscular block."( Optimal dose of neostigmine antagonizing cisatracurium-induced shallow neuromuscular block in elderly patients: a randomized control study.
Cao, M; Huang, H; Liao, Y; Ou, Y; Tong, J, 2023
)
1.52
"9, among which 40 µg/kg dosage may be a more optimized choice."( Optimal dose of neostigmine antagonizing cisatracurium-induced shallow neuromuscular block in elderly patients: a randomized control study.
Cao, M; Huang, H; Liao, Y; Ou, Y; Tong, J, 2023
)
1.26
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Roles (2)

RoleDescription
EC 3.1.1.7 (acetylcholinesterase) inhibitorAn EC 3.1.1.* (carboxylic ester hydrolase) inhibitor that interferes with the action of enzyme acetylcholinesterase (EC 3.1.1.7), which helps breaking down of acetylcholine into choline and acetic acid.
antidote to curare poisoningA role borne by a molecule that acts to counteract or neutralize the deleterious effects of curare.
[role information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Drug Classes (1)

ClassDescription
quaternary ammonium ionA derivative of ammonium, NH4(+), in which all four of the hydrogens bonded to nitrogen have been replaced with univalent (usually organyl) groups.
[compound class information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Protein Targets (14)

Potency Measurements

ProteinTaxonomyMeasurementAverage (µ)Min (ref.)Avg (ref.)Max (ref.)Bioassay(s)
GLS proteinHomo sapiens (human)Potency31.62280.35487.935539.8107AID624146
regulator of G-protein signaling 4Homo sapiens (human)Potency0.07520.531815.435837.6858AID504845
arylsulfatase AHomo sapiens (human)Potency0.30131.069113.955137.9330AID720538
euchromatic histone-lysine N-methyltransferase 2Homo sapiens (human)Potency1.00000.035520.977089.1251AID504332
muscarinic acetylcholine receptor M1Rattus norvegicus (Norway rat)Potency6.78330.00106.000935.4813AID943; AID944
lamin isoform A-delta10Homo sapiens (human)Potency5.01190.891312.067628.1838AID1487
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Inhibition Measurements

ProteinTaxonomyMeasurementAverageMin (ref.)Avg (ref.)Max (ref.)Bioassay(s)
ATP-binding cassette sub-family C member 3Homo sapiens (human)IC50 (µMol)133.00000.63154.45319.3000AID1473740
Multidrug resistance-associated protein 4Homo sapiens (human)IC50 (µMol)133.00000.20005.677410.0000AID1473741
AcetylcholinesteraseElectrophorus electricus (electric eel)IC50 (µMol)24.58000.00000.94539.9400AID1126181; AID1126626; AID1166296; AID1570270; AID1675610; AID1801407; AID1801483; AID1801534; AID1803295
Bile salt export pumpHomo sapiens (human)IC50 (µMol)422.66670.11007.190310.0000AID1443980; AID1449628; AID1473738
CholinesteraseHomo sapiens (human)IC50 (µMol)18.48000.00001.559910.0000AID1126182; AID1126627; AID1166298; AID1802986
CholinesteraseHomo sapiens (human)Ki35.50000.00001.51739.7300AID1799797
AcetylcholinesteraseHomo sapiens (human)IC50 (µMol)1.10000.00000.933210.0000AID1179497; AID1802986
AcetylcholinesteraseHomo sapiens (human)Ki35.50000.00001.27869.7300AID1799797
CholinesteraseEquus caballus (horse)IC50 (µMol)26.26500.00002.22149.4000AID1126596; AID1675611
Canalicular multispecific organic anion transporter 1Homo sapiens (human)IC50 (µMol)133.00002.41006.343310.0000AID1473739
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Biological Processes (65)

Processvia Protein(s)Taxonomy
xenobiotic metabolic processATP-binding cassette sub-family C member 3Homo sapiens (human)
xenobiotic transmembrane transportATP-binding cassette sub-family C member 3Homo sapiens (human)
bile acid and bile salt transportATP-binding cassette sub-family C member 3Homo sapiens (human)
glucuronoside transportATP-binding cassette sub-family C member 3Homo sapiens (human)
xenobiotic transportATP-binding cassette sub-family C member 3Homo sapiens (human)
transmembrane transportATP-binding cassette sub-family C member 3Homo sapiens (human)
leukotriene transportATP-binding cassette sub-family C member 3Homo sapiens (human)
monoatomic anion transmembrane transportATP-binding cassette sub-family C member 3Homo sapiens (human)
transport across blood-brain barrierATP-binding cassette sub-family C member 3Homo sapiens (human)
prostaglandin secretionMultidrug resistance-associated protein 4Homo sapiens (human)
cilium assemblyMultidrug resistance-associated protein 4Homo sapiens (human)
platelet degranulationMultidrug resistance-associated protein 4Homo sapiens (human)
xenobiotic metabolic processMultidrug resistance-associated protein 4Homo sapiens (human)
xenobiotic transmembrane transportMultidrug resistance-associated protein 4Homo sapiens (human)
bile acid and bile salt transportMultidrug resistance-associated protein 4Homo sapiens (human)
prostaglandin transportMultidrug resistance-associated protein 4Homo sapiens (human)
urate transportMultidrug resistance-associated protein 4Homo sapiens (human)
glutathione transmembrane transportMultidrug resistance-associated protein 4Homo sapiens (human)
transmembrane transportMultidrug resistance-associated protein 4Homo sapiens (human)
cAMP transportMultidrug resistance-associated protein 4Homo sapiens (human)
leukotriene transportMultidrug resistance-associated protein 4Homo sapiens (human)
monoatomic anion transmembrane transportMultidrug resistance-associated protein 4Homo sapiens (human)
export across plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
transport across blood-brain barrierMultidrug resistance-associated protein 4Homo sapiens (human)
guanine nucleotide transmembrane transportMultidrug resistance-associated protein 4Homo sapiens (human)
fatty acid metabolic processBile salt export pumpHomo sapiens (human)
bile acid biosynthetic processBile salt export pumpHomo sapiens (human)
xenobiotic metabolic processBile salt export pumpHomo sapiens (human)
xenobiotic transmembrane transportBile salt export pumpHomo sapiens (human)
response to oxidative stressBile salt export pumpHomo sapiens (human)
bile acid metabolic processBile salt export pumpHomo sapiens (human)
response to organic cyclic compoundBile salt export pumpHomo sapiens (human)
bile acid and bile salt transportBile salt export pumpHomo sapiens (human)
canalicular bile acid transportBile salt export pumpHomo sapiens (human)
protein ubiquitinationBile salt export pumpHomo sapiens (human)
regulation of fatty acid beta-oxidationBile salt export pumpHomo sapiens (human)
carbohydrate transmembrane transportBile salt export pumpHomo sapiens (human)
bile acid signaling pathwayBile salt export pumpHomo sapiens (human)
cholesterol homeostasisBile salt export pumpHomo sapiens (human)
response to estrogenBile salt export pumpHomo sapiens (human)
response to ethanolBile salt export pumpHomo sapiens (human)
xenobiotic export from cellBile salt export pumpHomo sapiens (human)
lipid homeostasisBile salt export pumpHomo sapiens (human)
phospholipid homeostasisBile salt export pumpHomo sapiens (human)
positive regulation of bile acid secretionBile salt export pumpHomo sapiens (human)
regulation of bile acid metabolic processBile salt export pumpHomo sapiens (human)
transmembrane transportBile salt export pumpHomo sapiens (human)
xenobiotic metabolic processCholinesteraseHomo sapiens (human)
learningCholinesteraseHomo sapiens (human)
negative regulation of cell population proliferationCholinesteraseHomo sapiens (human)
neuroblast differentiationCholinesteraseHomo sapiens (human)
peptide hormone processingCholinesteraseHomo sapiens (human)
response to alkaloidCholinesteraseHomo sapiens (human)
cocaine metabolic processCholinesteraseHomo sapiens (human)
negative regulation of synaptic transmissionCholinesteraseHomo sapiens (human)
response to glucocorticoidCholinesteraseHomo sapiens (human)
response to folic acidCholinesteraseHomo sapiens (human)
choline metabolic processCholinesteraseHomo sapiens (human)
acetylcholine catabolic processCholinesteraseHomo sapiens (human)
acetylcholine catabolic process in synaptic cleftAcetylcholinesteraseHomo sapiens (human)
regulation of receptor recyclingAcetylcholinesteraseHomo sapiens (human)
osteoblast developmentAcetylcholinesteraseHomo sapiens (human)
acetylcholine catabolic processAcetylcholinesteraseHomo sapiens (human)
cell adhesionAcetylcholinesteraseHomo sapiens (human)
nervous system developmentAcetylcholinesteraseHomo sapiens (human)
synapse assemblyAcetylcholinesteraseHomo sapiens (human)
receptor internalizationAcetylcholinesteraseHomo sapiens (human)
negative regulation of synaptic transmission, cholinergicAcetylcholinesteraseHomo sapiens (human)
amyloid precursor protein metabolic processAcetylcholinesteraseHomo sapiens (human)
positive regulation of protein secretionAcetylcholinesteraseHomo sapiens (human)
retina development in camera-type eyeAcetylcholinesteraseHomo sapiens (human)
acetylcholine receptor signaling pathwayAcetylcholinesteraseHomo sapiens (human)
positive regulation of cold-induced thermogenesisAcetylcholinesteraseHomo sapiens (human)
xenobiotic metabolic processCanalicular multispecific organic anion transporter 1Homo sapiens (human)
xenobiotic transmembrane transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
negative regulation of gene expressionCanalicular multispecific organic anion transporter 1Homo sapiens (human)
bile acid and bile salt transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
bilirubin transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
heme catabolic processCanalicular multispecific organic anion transporter 1Homo sapiens (human)
xenobiotic export from cellCanalicular multispecific organic anion transporter 1Homo sapiens (human)
transmembrane transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
transepithelial transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
leukotriene transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
monoatomic anion transmembrane transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
transport across blood-brain barrierCanalicular multispecific organic anion transporter 1Homo sapiens (human)
xenobiotic transport across blood-brain barrierCanalicular multispecific organic anion transporter 1Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Molecular Functions (38)

Processvia Protein(s)Taxonomy
ATP bindingATP-binding cassette sub-family C member 3Homo sapiens (human)
ABC-type xenobiotic transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
glucuronoside transmembrane transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ABC-type glutathione S-conjugate transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ABC-type bile acid transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ATP hydrolysis activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ATPase-coupled transmembrane transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
xenobiotic transmembrane transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ATPase-coupled inorganic anion transmembrane transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
icosanoid transmembrane transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ABC-type transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
guanine nucleotide transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
protein bindingMultidrug resistance-associated protein 4Homo sapiens (human)
ATP bindingMultidrug resistance-associated protein 4Homo sapiens (human)
ABC-type xenobiotic transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
prostaglandin transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
urate transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
purine nucleotide transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
ABC-type glutathione S-conjugate transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
ABC-type bile acid transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
efflux transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
15-hydroxyprostaglandin dehydrogenase (NAD+) activityMultidrug resistance-associated protein 4Homo sapiens (human)
ATP hydrolysis activityMultidrug resistance-associated protein 4Homo sapiens (human)
glutathione transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
ATPase-coupled transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
xenobiotic transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
ATPase-coupled inorganic anion transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
ABC-type transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
protein bindingBile salt export pumpHomo sapiens (human)
ATP bindingBile salt export pumpHomo sapiens (human)
ABC-type xenobiotic transporter activityBile salt export pumpHomo sapiens (human)
bile acid transmembrane transporter activityBile salt export pumpHomo sapiens (human)
canalicular bile acid transmembrane transporter activityBile salt export pumpHomo sapiens (human)
carbohydrate transmembrane transporter activityBile salt export pumpHomo sapiens (human)
ABC-type bile acid transporter activityBile salt export pumpHomo sapiens (human)
ATP hydrolysis activityBile salt export pumpHomo sapiens (human)
amyloid-beta bindingCholinesteraseHomo sapiens (human)
catalytic activityCholinesteraseHomo sapiens (human)
acetylcholinesterase activityCholinesteraseHomo sapiens (human)
cholinesterase activityCholinesteraseHomo sapiens (human)
protein bindingCholinesteraseHomo sapiens (human)
hydrolase activity, acting on ester bondsCholinesteraseHomo sapiens (human)
enzyme bindingCholinesteraseHomo sapiens (human)
choline bindingCholinesteraseHomo sapiens (human)
identical protein bindingCholinesteraseHomo sapiens (human)
amyloid-beta bindingAcetylcholinesteraseHomo sapiens (human)
acetylcholinesterase activityAcetylcholinesteraseHomo sapiens (human)
cholinesterase activityAcetylcholinesteraseHomo sapiens (human)
protein bindingAcetylcholinesteraseHomo sapiens (human)
collagen bindingAcetylcholinesteraseHomo sapiens (human)
hydrolase activityAcetylcholinesteraseHomo sapiens (human)
serine hydrolase activityAcetylcholinesteraseHomo sapiens (human)
acetylcholine bindingAcetylcholinesteraseHomo sapiens (human)
protein homodimerization activityAcetylcholinesteraseHomo sapiens (human)
laminin bindingAcetylcholinesteraseHomo sapiens (human)
protein bindingCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ATP bindingCanalicular multispecific organic anion transporter 1Homo sapiens (human)
organic anion transmembrane transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ABC-type xenobiotic transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
bilirubin transmembrane transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ABC-type glutathione S-conjugate transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ATP hydrolysis activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ATPase-coupled transmembrane transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
xenobiotic transmembrane transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ATPase-coupled inorganic anion transmembrane transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ABC-type transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Ceullar Components (29)

Processvia Protein(s)Taxonomy
plasma membraneATP-binding cassette sub-family C member 3Homo sapiens (human)
basal plasma membraneATP-binding cassette sub-family C member 3Homo sapiens (human)
basolateral plasma membraneATP-binding cassette sub-family C member 3Homo sapiens (human)
membraneATP-binding cassette sub-family C member 3Homo sapiens (human)
nucleolusMultidrug resistance-associated protein 4Homo sapiens (human)
Golgi apparatusMultidrug resistance-associated protein 4Homo sapiens (human)
plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
membraneMultidrug resistance-associated protein 4Homo sapiens (human)
basolateral plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
apical plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
platelet dense granule membraneMultidrug resistance-associated protein 4Homo sapiens (human)
external side of apical plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
basolateral plasma membraneBile salt export pumpHomo sapiens (human)
Golgi membraneBile salt export pumpHomo sapiens (human)
endosomeBile salt export pumpHomo sapiens (human)
plasma membraneBile salt export pumpHomo sapiens (human)
cell surfaceBile salt export pumpHomo sapiens (human)
apical plasma membraneBile salt export pumpHomo sapiens (human)
intercellular canaliculusBile salt export pumpHomo sapiens (human)
intracellular canaliculusBile salt export pumpHomo sapiens (human)
recycling endosomeBile salt export pumpHomo sapiens (human)
recycling endosome membraneBile salt export pumpHomo sapiens (human)
extracellular exosomeBile salt export pumpHomo sapiens (human)
membraneBile salt export pumpHomo sapiens (human)
extracellular regionCholinesteraseHomo sapiens (human)
nuclear envelope lumenCholinesteraseHomo sapiens (human)
endoplasmic reticulum lumenCholinesteraseHomo sapiens (human)
blood microparticleCholinesteraseHomo sapiens (human)
plasma membraneCholinesteraseHomo sapiens (human)
extracellular spaceCholinesteraseHomo sapiens (human)
extracellular regionAcetylcholinesteraseHomo sapiens (human)
basement membraneAcetylcholinesteraseHomo sapiens (human)
extracellular spaceAcetylcholinesteraseHomo sapiens (human)
nucleusAcetylcholinesteraseHomo sapiens (human)
Golgi apparatusAcetylcholinesteraseHomo sapiens (human)
plasma membraneAcetylcholinesteraseHomo sapiens (human)
cell surfaceAcetylcholinesteraseHomo sapiens (human)
membraneAcetylcholinesteraseHomo sapiens (human)
neuromuscular junctionAcetylcholinesteraseHomo sapiens (human)
synaptic cleftAcetylcholinesteraseHomo sapiens (human)
synapseAcetylcholinesteraseHomo sapiens (human)
perinuclear region of cytoplasmAcetylcholinesteraseHomo sapiens (human)
side of membraneAcetylcholinesteraseHomo sapiens (human)
plasma membraneCanalicular multispecific organic anion transporter 1Homo sapiens (human)
cell surfaceCanalicular multispecific organic anion transporter 1Homo sapiens (human)
apical plasma membraneCanalicular multispecific organic anion transporter 1Homo sapiens (human)
intercellular canaliculusCanalicular multispecific organic anion transporter 1Homo sapiens (human)
apical plasma membraneCanalicular multispecific organic anion transporter 1Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Bioassays (54)

Assay IDTitleYearJournalArticle
AID504749qHTS profiling for inhibitors of Plasmodium falciparum proliferation2011Science (New York, N.Y.), Aug-05, Volume: 333, Issue:6043
Chemical genomic profiling for antimalarial therapies, response signatures, and molecular targets.
AID651635Viability Counterscreen for Primary qHTS for Inhibitors of ATXN expression
AID504812Inverse Agonists of the Thyroid Stimulating Hormone Receptor: HTS campaign2010Endocrinology, Jul, Volume: 151, Issue:7
A small molecule inverse agonist for the human thyroid-stimulating hormone receptor.
AID1347405qHTS to identify inhibitors of the type 1 interferon - major histocompatibility complex class I in skeletal muscle: primary screen against the NCATS LOPAC collection2020ACS chemical biology, 07-17, Volume: 15, Issue:7
High-Throughput Screening to Identify Inhibitors of the Type I Interferon-Major Histocompatibility Complex Class I Pathway in Skeletal Muscle.
AID1347049Natriuretic polypeptide receptor (hNpr1) antagonism - Pilot screen2019Science translational medicine, 07-10, Volume: 11, Issue:500
Inhibition of natriuretic peptide receptor 1 reduces itch in mice.
AID1347058CD47-SIRPalpha protein protein interaction - HTRF assay qHTS validation2019PloS one, , Volume: 14, Issue:7
Quantitative high-throughput screening assays for the discovery and development of SIRPα-CD47 interaction inhibitors.
AID1508630Primary qHTS for small molecule stabilizers of the endoplasmic reticulum resident proteome: Secreted ER Calcium Modulated Protein (SERCaMP) assay2021Cell reports, 04-27, Volume: 35, Issue:4
A target-agnostic screen identifies approved drugs to stabilize the endoplasmic reticulum-resident proteome.
AID1347050Natriuretic polypeptide receptor (hNpr2) antagonism - Pilot subtype selectivity assay2019Science translational medicine, 07-10, Volume: 11, Issue:500
Inhibition of natriuretic peptide receptor 1 reduces itch in mice.
AID1347151Optimization of GU AMC qHTS for Zika virus inhibitors: Unlinked NS2B-NS3 protease assay2020Proceedings of the National Academy of Sciences of the United States of America, 12-08, Volume: 117, Issue:49
Therapeutic candidates for the Zika virus identified by a high-throughput screen for Zika protease inhibitors.
AID1347082qHTS for Inhibitors of the Functional Ribonucleoprotein Complex (vRNP) of Lassa (LASV) Arenavirus: LASV Primary Screen - GLuc reporter signal2020Antiviral research, 01, Volume: 173A cell-based, infectious-free, platform to identify inhibitors of lassa virus ribonucleoprotein (vRNP) activity.
AID504836Inducers of the Endoplasmic Reticulum Stress Response (ERSR) in human glioma: Validation2002The Journal of biological chemistry, Apr-19, Volume: 277, Issue:16
Sustained ER Ca2+ depletion suppresses protein synthesis and induces activation-enhanced cell death in mast cells.
AID588349qHTS for Inhibitors of ATXN expression: Validation of Cytotoxic Assay
AID1347059CD47-SIRPalpha protein protein interaction - Alpha assay qHTS validation2019PloS one, , Volume: 14, Issue:7
Quantitative high-throughput screening assays for the discovery and development of SIRPα-CD47 interaction inhibitors.
AID1347410qHTS for inhibitors of adenylyl cyclases using a fission yeast platform: a pilot screen against the NCATS LOPAC library2019Cellular signalling, 08, Volume: 60A fission yeast platform for heterologous expression of mammalian adenylyl cyclases and high throughput screening.
AID1347045Natriuretic polypeptide receptor (hNpr1) antagonism - Pilot counterscreen GloSensor control cell line2019Science translational medicine, 07-10, Volume: 11, Issue:500
Inhibition of natriuretic peptide receptor 1 reduces itch in mice.
AID504810Antagonists of the Thyroid Stimulating Hormone Receptor: HTS campaign2010Endocrinology, Jul, Volume: 151, Issue:7
A small molecule inverse agonist for the human thyroid-stimulating hormone receptor.
AID1347057CD47-SIRPalpha protein protein interaction - LANCE assay qHTS validation2019PloS one, , Volume: 14, Issue:7
Quantitative high-throughput screening assays for the discovery and development of SIRPα-CD47 interaction inhibitors.
AID1347083qHTS for Inhibitors of the Functional Ribonucleoprotein Complex (vRNP) of Lassa (LASV) Arenavirus: Viability assay - alamar blue signal for LASV Primary Screen2020Antiviral research, 01, Volume: 173A cell-based, infectious-free, platform to identify inhibitors of lassa virus ribonucleoprotein (vRNP) activity.
AID588378qHTS for Inhibitors of ATXN expression: Validation
AID1347086qHTS for Inhibitors of the Functional Ribonucleoprotein Complex (vRNP) of Lymphocytic Choriomeningitis Arenaviruses (LCMV): LCMV Primary Screen - GLuc reporter signal2020Antiviral research, 01, Volume: 173A cell-based, infectious-free, platform to identify inhibitors of lassa virus ribonucleoprotein (vRNP) activity.
AID1803295AChE and BuChE Activity Assay from Article 10.3109/14756366.2012.688041: \\Synthesis and anticholinesterase activities of novel 1,3,4-thiadiazole based compounds.\\2013Journal of enzyme inhibition and medicinal chemistry, Aug, Volume: 28, Issue:4
Synthesis and anticholinesterase activities of novel 1,3,4-thiadiazole based compounds.
AID1801534AChE and BChE Inhibition Activity from Article 10.1016/j.bioorg.2016.01.004: \\One-pot synthesis of tetrazole-1,2,5,6-tetrahydronicotinonitriles and cholinesterase inhibition: Probing the plausible reaction mechanism via computational studies.\\2016Bioorganic chemistry, Apr, Volume: 65One-pot synthesis of tetrazole-1,2,5,6-tetrahydronicotinonitriles and cholinesterase inhibition: Probing the plausible reaction mechanism via computational studies.
AID1799797Inhibition Assay from Article 10.1111/j.1747-0285.2012.01435.x: \\Synthesis and Biological Evaluation of 3-thiazolocoumarinyl Schiff-base Derivatives as Cholinesterase Inhibitors.\\2012Chemical biology & drug design, Oct, Volume: 80, Issue:4
Synthesis and biological evaluation of 3-thiazolocoumarinyl Schiff-base derivatives as cholinesterase inhibitors.
AID1802986In Vitro Assay from Article 10.3109/14756366.2010.496362: \\The preparation, in vitro screening and molecular docking of symmetrical bisquaternary cholinesterase inhibitors containing a but-(2E)-en-1,4-diyl connecting linkage.\\2011Journal of enzyme inhibition and medicinal chemistry, Apr, Volume: 26, Issue:2
The preparation, in vitro screening and molecular docking of symmetrical bisquaternary cholinesterase inhibitors containing a but-(2E)-en-1,4-diyl connecting linkage.
AID1801407AChE and BChE Inhibition Assay from Article 10.1111/cbdd.12579: \\Syntheses, cholinesterases inhibition, and molecular docking studies of pyrido[2,3-b]pyrazine derivatives.\\2015Chemical biology & drug design, Nov, Volume: 86, Issue:5
Syntheses, cholinesterases inhibition, and molecular docking studies of pyrido[2,3-b]pyrazine derivatives.
AID1801483AChE and BChE Inhibitory Activities from Article 10.1016/j.bioorg.2015.09.009: \\Synthesis, cholinesterase inhibition and molecular modelling studies of coumarin linked thiourea derivatives.\\2015Bioorganic chemistry, Dec, Volume: 63Synthesis, cholinesterase inhibition and molecular modelling studies of coumarin linked thiourea derivatives.
AID1570270Inhibition of electric eel AChE using acetylthiocholine iodide as substrate preincubated for 10 mins followed by substrate addition measured after 15 mins by Ellman's method2019European journal of medicinal chemistry, Oct-15, Volume: 180Triazole derivatives as inhibitors of Alzheimer's disease: Current developments and structure-activity relationships.
AID1209582Unbound volume of distribution in Sprague-Dawley rat brain slices at 100 nM after 5 hrs2011Drug metabolism and disposition: the biological fate of chemicals, Mar, Volume: 39, Issue:3
Measurement of unbound drug exposure in brain: modeling of pH partitioning explains diverging results between the brain slice and brain homogenate methods.
AID1473741Inhibition of human MRP4 overexpressed in Sf9 cell membrane vesicles assessed as uptake of [3H]-estradiol-17beta-D-glucuronide in presence of ATP and GSH measured after 20 mins by membrane vesicle transport assay2013Toxicological sciences : an official journal of the Society of Toxicology, Nov, Volume: 136, Issue:1
A multifactorial approach to hepatobiliary transporter assessment enables improved therapeutic compound development.
AID1209593Dissociation constant, pKa of the acidic compound by capillary electrophoresis-mass spectrometry analysis2011Drug metabolism and disposition: the biological fate of chemicals, Mar, Volume: 39, Issue:3
Measurement of unbound drug exposure in brain: modeling of pH partitioning explains diverging results between the brain slice and brain homogenate methods.
AID1179497Inhibition of AChE (unknown origin) using ACh chloride as substrate preincubated for 15 mins before substrate addition by Ellman method2014Bioorganic & medicinal chemistry letters, Aug-01, Volume: 24, Issue:15
Synthesis and characterization of novel 1,2-oxazine-based small molecules that targets acetylcholinesterase.
AID1209583Unbound drug partitioning coefficient, Kp of the compound assessed as ratio of unbound concentration in Sprague-Dawley rat brain to unbound concentration in plasma2011Drug metabolism and disposition: the biological fate of chemicals, Mar, Volume: 39, Issue:3
Measurement of unbound drug exposure in brain: modeling of pH partitioning explains diverging results between the brain slice and brain homogenate methods.
AID1126627Inhibition of human BChE using butyrylthiocholine iodide as substrate preincubated for 10 mins before substrate addition after 15 mins by Ellman's method2014European journal of medicinal chemistry, May-06, Volume: 78Synthesis, crystal structure and biological evaluation of some novel 1,2,4-triazolo[3,4-b]-1,3,4-thiadiazoles and 1,2,4-triazolo[3,4-b]-1,3,4-thiadiazines.
AID1675612Selectivity index, ratio of IC50 for electric eel AChE to IC50 for equine BuChE2020Bioorganic & medicinal chemistry letters, 11-01, Volume: 30, Issue:21
Synthesis and in vitro evaluation of vanillin derivatives as multi-target therapeutics for the treatment of Alzheimer's disease.
AID1473738Inhibition of human BSEP overexpressed in Sf9 cell membrane vesicles assessed as uptake of [3H]-taurocholate in presence of ATP measured after 15 to 20 mins by membrane vesicle transport assay2013Toxicological sciences : an official journal of the Society of Toxicology, Nov, Volume: 136, Issue:1
A multifactorial approach to hepatobiliary transporter assessment enables improved therapeutic compound development.
AID1675611Inhibition of equine BuChE by Ellman's method2020Bioorganic & medicinal chemistry letters, 11-01, Volume: 30, Issue:21
Synthesis and in vitro evaluation of vanillin derivatives as multi-target therapeutics for the treatment of Alzheimer's disease.
AID1166298Inhibition of human BChE by Ellman's method2014Bioorganic & medicinal chemistry, Nov-01, Volume: 22, Issue:21
Active compounds from a diverse library of triazolothiadiazole and triazolothiadiazine scaffolds: synthesis, crystal structure determination, cytotoxicity, cholinesterase inhibitory activity, and binding mode analysis.
AID1473739Inhibition of human MRP2 overexpressed in Sf9 cell membrane vesicles assessed as uptake of [3H]-estradiol-17beta-D-glucuronide in presence of ATP and GSH measured after 20 mins by membrane vesicle transport assay2013Toxicological sciences : an official journal of the Society of Toxicology, Nov, Volume: 136, Issue:1
A multifactorial approach to hepatobiliary transporter assessment enables improved therapeutic compound development.
AID1166296Inhibition of electric eel AChE by Ellman's method2014Bioorganic & medicinal chemistry, Nov-01, Volume: 22, Issue:21
Active compounds from a diverse library of triazolothiadiazole and triazolothiadiazine scaffolds: synthesis, crystal structure determination, cytotoxicity, cholinesterase inhibitory activity, and binding mode analysis.
AID1126596Inhibition of BuChE in equine serum using butyrylthiocholine chloride as substrate preincubated with enzyme for 10 mins prior to substrate challenge for 15 mins by Ellman's method2014European journal of medicinal chemistry, May-06, Volume: 78Novel structural hybrids of pyrazolobenzothiazines with benzimidazoles as cholinesterase inhibitors.
AID1473740Inhibition of human MRP3 overexpressed in Sf9 insect cell membrane vesicles assessed as uptake of [3H]-estradiol-17beta-D-glucuronide in presence of ATP and GSH measured after 10 mins by membrane vesicle transport assay2013Toxicological sciences : an official journal of the Society of Toxicology, Nov, Volume: 136, Issue:1
A multifactorial approach to hepatobiliary transporter assessment enables improved therapeutic compound development.
AID1209586Drug uptake in Sprague-Dawley rat brain slices in presence of 1 uM of decynium-222011Drug metabolism and disposition: the biological fate of chemicals, Mar, Volume: 39, Issue:3
Measurement of unbound drug exposure in brain: modeling of pH partitioning explains diverging results between the brain slice and brain homogenate methods.
AID1443980Inhibition of human BSEP expressed in fall armyworm sf9 cell plasma membrane vesicles assessed as reduction in vesicle-associated [3H]-taurocholate transport preincubated for 10 mins prior to ATP addition measured after 15 mins in presence of [3H]-tauroch2010Toxicological sciences : an official journal of the Society of Toxicology, Dec, Volume: 118, Issue:2
Interference with bile salt export pump function is a susceptibility factor for human liver injury in drug development.
AID1126181Inhibition of electric eel acetylcholinesterase using acetylthiocholine iodide as substrate preincubated for 10 mins before substrate addition after 15 mins by Ellman's method2014European journal of medicinal chemistry, May-06, Volume: 78Synthesis, cytotoxicity and molecular modelling studies of new phenylcinnamide derivatives as potent inhibitors of cholinesterases.
AID1682595Inhibition of AChE (unknown origin) at 1 to 25 uM2021Bioorganic & medicinal chemistry letters, 01-01, Volume: 31Synthesis and biological activity of (±)-7,3',4'-trihydroxyhomoisoflavan and its analogs.
AID1126626Inhibition of electric eel acetylcholinesterase using acetylthiocholine iodide as substrate preincubated for 10 mins before substrate addition after 15 mins by Ellman's method2014European journal of medicinal chemistry, May-06, Volume: 78Synthesis, crystal structure and biological evaluation of some novel 1,2,4-triazolo[3,4-b]-1,3,4-thiadiazoles and 1,2,4-triazolo[3,4-b]-1,3,4-thiadiazines.
AID1126182Inhibition of human BChE using butyrylthiocholine iodide as substrate preincubated for 10 mins before substrate addition after 15 mins by Ellman's method2014European journal of medicinal chemistry, May-06, Volume: 78Synthesis, cytotoxicity and molecular modelling studies of new phenylcinnamide derivatives as potent inhibitors of cholinesterases.
AID1126594Inhibition of electric eel AChE type VI-S using acetylthiocholine iodide as substrate preincubated with enzyme for 10 mins prior to substrate challenge for 15 mins by Ellman's method2014European journal of medicinal chemistry, May-06, Volume: 78Novel structural hybrids of pyrazolobenzothiazines with benzimidazoles as cholinesterase inhibitors.
AID1209581Fraction unbound in Sprague-Dawley rat brain homogenates at 5 uM by equilibrium dialysis analysis2011Drug metabolism and disposition: the biological fate of chemicals, Mar, Volume: 39, Issue:3
Measurement of unbound drug exposure in brain: modeling of pH partitioning explains diverging results between the brain slice and brain homogenate methods.
AID1449628Inhibition of human BSEP expressed in baculovirus transfected fall armyworm Sf21 cell membranes vesicles assessed as reduction in ATP-dependent [3H]-taurocholate transport into vesicles incubated for 5 mins by Topcount based rapid filtration method2012Drug metabolism and disposition: the biological fate of chemicals, Dec, Volume: 40, Issue:12
Mitigating the inhibition of human bile salt export pump by drugs: opportunities provided by physicochemical property modulation, in silico modeling, and structural modification.
AID1209585Drug uptake in Sprague-Dawley rat brain slices in presence of 50 nM of monensin2011Drug metabolism and disposition: the biological fate of chemicals, Mar, Volume: 39, Issue:3
Measurement of unbound drug exposure in brain: modeling of pH partitioning explains diverging results between the brain slice and brain homogenate methods.
AID1675610Inhibition of electric eel AChE by Ellman's method2020Bioorganic & medicinal chemistry letters, 11-01, Volume: 30, Issue:21
Synthesis and in vitro evaluation of vanillin derivatives as multi-target therapeutics for the treatment of Alzheimer's disease.
AID1159607Screen for inhibitors of RMI FANCM (MM2) intereaction2016Journal of biomolecular screening, Jul, Volume: 21, Issue:6
A High-Throughput Screening Strategy to Identify Protein-Protein Interaction Inhibitors That Block the Fanconi Anemia DNA Repair Pathway.
AID1345946Human acetylcholinesterase (Cartwright blood group) (Hydrolases)2007Bioorganic & medicinal chemistry, Dec-01, Volume: 15, Issue:23
Synthesis and screening for acetylcholinesterase inhibitor activity of some novel 2-butyl-1,3-diaza-spiro[4,4]non-1-en-4-ones: derivatives of irbesartan key intermediate.
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (4,596)

TimeframeStudies, This Drug (%)All Drugs %
pre-19902914 (63.40)18.7374
1990's560 (12.18)18.2507
2000's435 (9.46)29.6817
2010's470 (10.23)24.3611
2020's217 (4.72)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Market Indicators

Research Demand Index: 80.79

According to the monthly volume, diversity, and competition of internet searches for this compound, as well the volume and growth of publications, there is estimated to be very strong demand-to-supply ratio for research on this compound.

MetricThis Compound (vs All)
Research Demand Index80.79 (24.57)
Research Supply Index8.61 (2.92)
Research Growth Index4.46 (4.65)
Search Engine Demand Index148.29 (26.88)
Search Engine Supply Index2.00 (0.95)

This Compound (80.79)

All Compounds (24.57)

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials454 (9.04%)5.53%
Reviews198 (3.94%)6.00%
Case Studies337 (6.71%)4.05%
Observational30 (0.60%)0.25%
Other4,001 (79.70%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (170)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
A Randomised, Double Blind Cross-over Study of Serial MRCP Following Morphine-neostigmine and Secretin Provocation in Healthy Volunteers [NCT01134848]Phase 410 participants (Actual)Interventional2009-01-31Completed
The Effect of Sugammadex of EEG-derived Index Values [NCT01142648]Phase 430 participants (Anticipated)Interventional2009-04-30Completed
A Prospective, Double-blind, Randomized Study to Investigate the Effect of Sugammadex vs. Neostigmine/Glycopyrrolate on Emergence Delirium During Sevoflurane-rocuronium Anesthesia in Pediatric Patients [NCT03229486]Phase 440 participants (Actual)Interventional2017-03-01Completed
Dose Finding Study for Reversal of Vecuronium-induced Neuromuscular Blockade at Train-of-four Ratio 0.3 With Sugammadex and Neostigmine [NCT03656614]121 participants (Actual)Observational [Patient Registry]2018-07-26Completed
A Phase 4 Double-Blinded, Randomized, Active Comparator-Controlled Clinical Trial to Study the Efficacy, Safety, and Pharmacokinetics of Sugammadex (MK-8616) for Reversal of Neuromuscular Blockade in Pediatric Participants [NCT03351608]Phase 4288 participants (Actual)Interventional2018-02-12Completed
A Phase 4 Randomized, Active-Comparator Controlled Trial to Study the Efficacy and Safety of Sugammadex (MK-8616) for the Reversal of Neuromuscular Blockade Induced by Either Rocuronium Bromide or Vecuronium Bromide in Morbidly Obese Subjects [NCT03346070]Phase 4207 participants (Actual)Interventional2018-01-01Completed
A Double-blind, Randomized, Parallel Study to Compare the Efficacy of Sugammadex Versus Neostigmine for Reversal of Neuromuscular Blockade at the End of Kidney Transplantation Surgery in Patients With Severe Kidney Dysfunction [NCT03923556]Phase 4100 participants (Anticipated)Interventional2021-02-02Recruiting
Neostigmine Reversal And Neuromuscular Recovery [NCT02433808]Phase 4120 participants (Actual)Interventional2015-04-30Completed
A Phase 4 Randomized, Active-Comparator Controlled Clinical Trial to Study the Safety of Sugammadex (MK-8616) for the Reversal of Neuromuscular Blockade Induced by Either Rocuronium Bromide or Vecuronium Bromide in American Society of Anesthesiologists (A [NCT03346057]Phase 4344 participants (Actual)Interventional2017-12-20Completed
A Novel Application of Iontophoresis in the Transcutaneous Delivery of a Prokinetic Agent for the Promotion of Bowel Evacuation [NCT02370862]Early Phase 128 participants (Actual)Interventional2013-02-28Completed
A Randomized Prospective Study to Compare the Effectiveness of Neostigmine Versus Sugammadex in Length of PACU Stay in ASA II and III Patients Undergoing Sleeve Gastrectomy Bariatric Surgery [NCT03276026]Phase 468 participants (Actual)Interventional2018-02-12Terminated(stopped due to PI left the Institution.)
A Phase IV Investigation of Sugammadex in Outpatient Urological Procedures [NCT03138967]Phase 454 participants (Actual)Interventional2017-09-18Completed
Comparison Between the Efficacy of Neostigmine Versus Sugammadex Reversal of Rocuronium Induced Neuromuscular Blockade In Paediatric Patients. [NCT03137290]80 participants (Actual)Interventional2014-12-01Completed
Does Residual Muscular Weakness Lead to an Increase in Respiratory Complications in Bariatric Patients? [NCT02037516]330 participants (Actual)Interventional2014-01-31Completed
The Effect of Administration of Sugammadex on the Occurrence of Emergence Agitation in Pediatric Strabismus Surgery-prospective Randomized Controlled Trial [NCT06035757]Phase 476 participants (Anticipated)Interventional2023-09-15Not yet recruiting
Effectiveness of Sugammadex Versus Neostigmine on Neuromuscular Reversal in Pediatric Patients Undergoing Laparoscopic Appendectomy for Acute Appendicitis: A Randomized Controlled Trial [NCT05256901]Phase 4120 participants (Anticipated)Interventional2023-07-19Recruiting
Efficacy of Intra-articular Neostigmine Versus Ketamine for Postoperative Analgesia in Arthroscopic Knee Surgery [NCT03248648]Phase 2/Phase 3100 participants (Actual)Interventional2017-03-01Completed
Effect of Sugammadex Versus Neostigmine/Atropine Combination on Cognitive Function After Elective Adult Surgery [NCT02419352]160 participants (Actual)Interventional2010-09-30Completed
The Role of Curarization During Anesthesia for Gynecologic Surgical Laparoscopic Procedures: a Double Blind Randomized Controlled Trial. [NCT03519633]Phase 2100 participants (Anticipated)Interventional2018-07-30Not yet recruiting
Pharmacokinetic-pharmacodynamic Analysis of Reversal of Rocuronium-induced Neuromuscular Blockade by Sugammadex in Children [NCT03943888]Phase 240 participants (Actual)Interventional2019-08-12Completed
A Randomized Trial of Deep Neuromuscular Blockade Reversed With Sugammadex Versus Moderate Neuromuscular Block Reversed With Neostigmine, on Postoperative Quality of Recovery [NCT03034577]Phase 4350 participants (Actual)Interventional2017-06-16Completed
Visualization of Regional Lung Ventilation During Neostigmine or Sugammadex Enhanced Recovery From Moderate Residual Neuromuscular Blockade in the Anaesthetized Rat Using Functional Respiratory Imaging [NCT02284412]Phase 413 participants (Actual)Interventional2014-12-31Completed
[NCT02286752]Phase 498 participants (Actual)Interventional2014-06-30Completed
Different Doses of Neostigmine for Reversal of Cisatracurium-induced Moderate Neuromuscular Blockade in Children Under Sevoflurane Anesthesia [NCT05053594]Phase 460 participants (Anticipated)Interventional2021-10-01Not yet recruiting
A Double-blind, Randomized, Parallel Design Study to Compare Postoperative Recovery Between the Sugammadex Group and the Neostigmine Group in Patients After COVID-19. [NCT05817019]Phase 4300 participants (Anticipated)Interventional2023-04-20Not yet recruiting
Decurarization After Thoracic Anesthesia - A Prospective Multicenter Double-blind Randomized Trial Comparing Sugammadex vs Neostigmine Reversal After Thoracic Anesthesia [NCT02256280]Phase 470 participants (Actual)Interventional2015-01-31Terminated(stopped due to Low recruiting rate due to not activation of some collaborator centers)
Accessor Blinded Randomized Controlled Study Evaluating the Efficacy and Safety of Sugammadex in High-Risk Ambulatory Surgeries [NCT03944473]Phase 40 participants (Actual)Interventional2019-06-20Withdrawn(stopped due to Stopped before IRB approval)
Prevention of Postoperative Events Following Reversal With Sugammadex or Neostigmine [NCT02825576]Phase 430 participants (Actual)Interventional2018-12-03Terminated(stopped due to Lack of Study Personnel)
The Role of Curarization During Anesthesia for Gynecologic Laparotomy Surgical Procedures: a Double Blind Randomized Controlled Trial [NCT03519724]Phase 2100 participants (Anticipated)Interventional2018-07-30Not yet recruiting
Comparison of Sugammadex and Neostigmine in Terms of Awakening, Pain, Agitation, Nausea and Vomiting in Pediatric Patients'' [NCT05618236]130 participants (Anticipated)Observational [Patient Registry]2022-11-08Active, not recruiting
A Randomized, Blinded, Prospective Study of the Combined Use of Low-dose Sugammadex Plus Neostigmine Administered for Reversal of Rocuronium-induced Neuromuscular Block in Obese Patients [NCT03328312]Early Phase 190 participants (Anticipated)Interventional2017-12-01Not yet recruiting
Recovery From Optimal Neuromuscular Blockade in the Critically Ill: Randomized Control Trial [NCT03791801]50 participants (Anticipated)Interventional2019-09-01Recruiting
Intrathecal Bupivacaine-Dexmedetomidine Compared to Intrathecal Bupivacaine-Neostigmine in Elective Caesarean Sections, Randomized Clinical Trial [NCT06055101]54 participants (Actual)Interventional2019-01-03Completed
A New Approach of Neostigmine in Unavoidable Post Operative Ileus After Surgery [NCT00676377]Phase 43 participants (Actual)Interventional2007-08-31Completed
The Impact of Intravenous Anaesthesia on Angiogenesis in Patients With Breast Cancer [NCT02839668]Phase 2120 participants (Actual)Interventional2016-08-31Completed
Electromyographic Activity of the Diaphragm and of the Rectus Abdominis and Intercostal Muscles During Neostigmine, Sugammadex, or Neostigmine-sugammadex Enhanced Recovery After Neuromuscular Blockade With Rocuronium. A Randomised Controlled Study in Heal [NCT02403063]Phase 418 participants (Actual)Interventional2015-09-30Completed
Effect of Sugammadex in Wakeup Procedure [NCT02390817]Phase 460 participants (Actual)Interventional2015-03-31Completed
Optimizing Post-operative Recovery in Bariatric Patients With Obstructive Sleep Apnea Undergoing Outpatient Surgery: A Comparison of Sugammadex and Neostigmine [NCT04570150]Phase 490 participants (Actual)Interventional2021-01-04Active, not recruiting
The Effect of Sugammadex Versus Neostigmine During Neuromuscular Blockade Reversal in Outpatient Surgeries - An Evaluation of Clinical and Associated Health Care Cost [NCT03579589]Phase 140 participants (Actual)Interventional2018-08-15Completed
Effect of Neuromuscular Blockade and Reversal by Sugammadex Versus Neostigmine on Breathing When Hypoxic or Hypercapnic in Volunteers [NCT02845375]Phase 446 participants (Actual)Interventional2016-09-01Completed
The Efficacy of Neostigmine as an Adjuvant to Bupivacaine for Intrathecal Block in Reducing the Incidence and Severity of Post-Dural Puncture Headache for Parturients Scheduled for Elective Caesarean Section [NCT03587441]Phase 4240 participants (Actual)Interventional2018-08-04Completed
Monitoring of Postoperative Residual Neuromuscular Blockade in Laparoscopic Surgery: Comparison of Neostigmine and Sugammadex [NCT03292965]80 participants (Actual)Interventional2017-09-28Completed
Sugammadex Compared With Neostigmin/Atropin for Neuromuscular Block Reversal in Patients With Obstructive Sleep Apnea [NCT02160223]Phase 474 participants (Actual)Interventional2012-01-31Completed
Comparison of Time to Full Recovery From Muscle Paralysis (TOF>0.9) and Extubation Using Sugammadex Versus Neostigmine/Glycopyrrolate in Patients With Pulmonary Disease in the Outpatient Bronchoscopy Suite [NCT04606901]Phase 458 participants (Actual)Interventional2021-04-08Completed
The Impact of Sugammadex on Ileus After Abdominal Wall Reconstruction [NCT05985343]Phase 4184 participants (Anticipated)Interventional2023-12-01Not yet recruiting
Is Aminophylline More Effective Than Neostigmine/Atropine Mixture in the Treatment of Post-dural Puncture Headache: A Randomized Clinical Trial [NCT03997006]Phase 460 participants (Actual)Interventional2019-01-01Completed
Safety and Efficacy of High Resolution Manometry in Studying Colonic Motility and Iontophoretic Administration of Prokinetic Agents [NCT02574611]Phase 10 participants (Actual)Interventional2015-10-13Withdrawn(stopped due to No reportable findings are possible. The PI/Co-PI were unable to recruit participants for this study. One participant was consented but did not undergo any study procedure.)
The Prevention and Treatment of SIRS in Patients With Cholestatic Jaundice After Operation. [NCT02279147]Phase 1/Phase 2100 participants (Anticipated)Interventional2014-08-31Recruiting
Reversal of Neuromuscular Blockade During the General Anaesthesia [NCT04048655]120 participants (Anticipated)Interventional2020-04-08Recruiting
Dose Finding Study for Sugammadex and Neostigmine at Residual Neuromuscular Blockade (T4/T1 = 0.5) [NCT00895609]Phase 499 participants (Actual)Interventional2009-03-31Completed
Effectiveness of Caudal Epidural Block on Intraoperative Blood Loss During Hypospadias Repair; A Randomized Clinical Trial [NCT02752308]Phase 2/Phase 360 participants (Actual)Interventional2014-09-30Completed
Recovery Profile of Sugammadex Versus Neostigmine in Pediatric Patients Undergoing Cardiac Catheterization: a Randomized Double-blind Study [NCT04258007]50 participants (Actual)Interventional2020-01-27Completed
Efficacy and Safety of Bowel Preparations for Colonoscopy in SCI [NCT00745095]Phase 4360 participants (Actual)Interventional2009-03-31Completed
Comparison of the Impacts of Sugammadex With Neostigmine on Patency of Laryngeal Opening (Glottic Aperture Angle) [NCT04545099]84 participants (Anticipated)Interventional2020-09-30Not yet recruiting
Residual Neuromuscular Blockade in Cardiac Surgery Patients [NCT03574337]Phase 40 participants (Actual)Interventional2018-08-01Withdrawn(stopped due to Inadequate funding)
Evaluation of The Effects of Neostigmine Versus Sugammadex on Renal Functions in Laparoscopic Cholecystecomy A Randomized Controlled Study [NCT06081738]Phase 464 participants (Actual)Interventional2023-03-01Active, not recruiting
A Multi-center, Randomized, Parallel-group, Comparative, Active-controlled, Safety-assessor Blinded Trial in Adult Subjects Comparing the Efficacy and Safety of Sugammadex (SCH 900616, ORG 25969) Administered at 1-2 PTC With Neostigmine Administered at Re [NCT00724932]Phase 3140 participants (Actual)Interventional2008-07-16Completed
Randomized Controlled Assessor Blinded Clinical Trial of Sugammadex Versus Neostigmine /Glycopyrrolate for Reversal of Rocuronium Induced Neuromuscular Blockade: Time to Discharge From Post Anesthesia Care Unit and Patient Satisfaction With Recovery [NCT03116997]Phase 3201 participants (Actual)Interventional2017-04-07Completed
Sugammadex Versus Neostigmine in Pediatric Day-case Cancer Surgery [NCT03996655]Phase 480 participants (Anticipated)Interventional2019-06-30Not yet recruiting
A Multi-center, Randomized, Parallel-group, Active-controlled, Safety-assessor Blinded Trial, Comparing the Efficacy and Safety of 2.0 mg.Kg-1 Sugammadex With 50 μg.Kg-1 Neostigmine Administered at Reappearance of T2 After Rocuronium in Chinese and Europe [NCT00825812]Phase 3308 participants (Actual)Interventional2010-01-31Completed
Recovery of Muscle Function After Deep Neuromuscular Block by Means of Dia-phragm Ultrasonography and Adductor Pollicis Acceleromyography: Comparison of Neostigmine vs. Sugammadex as Reversal Drugs. [NCT02698969]Phase 458 participants (Anticipated)Interventional2014-11-30Recruiting
A Phase 4 Double-blinded, Randomized, Active Comparator-controlled Clinical Trial to Study the Efficacy, Safety, and Pharmacokinetics of Sugammadex (MK-8616) for Reversal of Neuromuscular Blockade in Pediatric Participants Aged Birth to <2 Years [NCT03909165]Phase 4137 participants (Actual)Interventional2019-07-23Completed
Safety and Efficacy of Neostigmine Infusion as Adjuvant Therapy in Sepsis and Septic Shock [NCT04130230]Phase 250 participants (Anticipated)Interventional2019-03-06Recruiting
The Evaluation of the Analgesic Effect of Intraperitoneal Bupivacaine Versus Bupivacaine With Neostigmine on Postoperative Pain in Laparoscopic Cholecystectomy:A Prospective, Randomized, Comparative, Double-blind Study. [NCT04244097]Phase 256 participants (Actual)Interventional2020-04-10Completed
Epidural Neostigmine Dose Response for the Treatment of Labor Pain [NCT00779467]Phase 1200 participants (Actual)Interventional2008-10-31Completed
Comparison of Efficacy of Sugammadex Versus Neostigmine in Reversing Neuromuscular Blocks in Patients Having Outpatient Endoscopic Retrograde Cholangiopancreatography (ERCP). A Randomized, Double-Blinded Trial [NCT06136585]80 participants (Anticipated)Interventional2024-01-01Not yet recruiting
Dose Finding Study for Sugammadex and Neostigmine at Residual Neuromuscular Blockade (T4/T1 = 0.2) [NCT01006720]99 participants (Actual)Observational2009-03-31Completed
Neostigmine and Atropine for the Treatment of Post Dural Puncture Headache After Known Dural Puncture With a Tuohy Needle: A Pilot Study [NCT05116930]Phase 218 participants (Anticipated)Interventional2021-11-19Recruiting
Efficacy of Neostigmine as an Adjuvant to Bupivacaine in Ultrasound-guided Transversus Abdominis Plane Block as a Postoperative Analgesia After Caesarean Delivery. [NCT05785377]58 participants (Anticipated)Interventional2023-12-01Not yet recruiting
A Multi -Center Randomized Parallel Group Comparative Active Controlled Safety Assessor Blinded Phase 3a Pivotal Trial in Adult Subjects Comparing Org 25969 With Neostigmine as Reversal Agents of a Neuromuscular Block Induced by Rocuronium or Vecuronium a [NCT00451217]Phase 3198 participants (Actual)Interventional2005-11-17Completed
"Low Dose Sugammadex Combined With Neostigmine and Glycopyrrolate Versus Full Dose Sugammadex for Reversal of Rocuronium-induced Neuromuscular Blockade: a Cost Saving Strategy" [NCT02375217]Phase 456 participants (Actual)Interventional2014-10-31Completed
Appropriate Dose of Neostigmine for Reversal of Rocuronium and Cisatracurium [NCT01885715]112 participants (Actual)Interventional2013-06-30Completed
Effectiveness of Sugammadex on Muscle Relaxant Reversal in Preterm Neonates [NCT04566796]60 participants (Anticipated)Interventional2020-08-11Recruiting
[NCT01980069]72 participants (Actual)Interventional2013-11-30Completed
Comparison Sugammadex With Neostigmine in Laryngeal Microsurgery. [NCT02330172]44 participants (Actual)Interventional2014-05-31Completed
Effect of Neuromuscular Blockade Reversal With Sugammadex on Oxygenation, Pain and Arousal States in the Post Anesthesia Care Unit [NCT02243943]Phase 4100 participants (Actual)Interventional2014-09-30Completed
Acupuncture Versus Sham Acupuncture and Neostigmine for the Management of Postoperative Urinary Retention [NCT05898919]Phase 292 participants (Actual)Interventional2022-03-01Completed
A Multicenter, Randomized, Parallel Group Comparative, Active-Controlled, Safety-assessor Blinded. Phase IIIa, Pivotal Trial in Adult Subjects Comparing Org 25969 With Neostigmine as Reversal Agent of a Neuromuscular Block Induced by Maintenance Dosing of [NCT00473694]Phase 3182 participants (Actual)Interventional2005-11-28Completed
The Comparative Efficacy and Safety of Sugammadex and Neostigmine in Reversing Neuromuscular Blockade After General Anesthesia: A Prospective Randomized Control Study [NCT04997759]200 participants (Anticipated)Interventional2021-09-06Recruiting
Effect of Sugammadex Versus Neostigmine on the Occurrence of Respiratory Adverse Events in Children Undergoing Tonsillectomies: a Randomized Controlled Trial [NCT05354466]174 participants (Anticipated)Interventional2022-06-27Recruiting
Comparison of Effectiveness of Adding Ketamine or Neostigmine to Bupivacaine for Ultrasound Guided Serratus Anterior Plane Block in Modified Radical Mastectomy , Randomized Double Blinded Comparative Study. [NCT04544228]90 participants (Actual)Interventional2020-09-05Completed
[NCT02215382]Phase 436 participants (Actual)Interventional2014-08-31Completed
Pharmacokinetics of Neostigmine and Glycopyrrolate After Intravenous and Transcutaneous Administration by Iontophoresis [NCT04027972]Early Phase 113 participants (Actual)Interventional2020-03-09Active, not recruiting
Sugammadex Versus Neostigmine After Rocuronium Infusion During Liver Transplantation [NCT02697929]40 participants (Actual)Interventional2014-01-31Completed
Deep Versus Moderate Neuromuscular Blocks on Remifentanil Requirements in Patients Undergoing Surgical Pleth Index-guided Analgesia for Laparoscopic Gastrectomy [NCT04205097]120 participants (Actual)Interventional2019-12-23Completed
Comparison of Sugammadex Versus Neostigmine in Women at High Risk of Postoperative Nausea and Vomiting After Laparoscopic Gynaecological Surgery: A Randomized Controlled Trial [NCT02666014]Phase 3184 participants (Actual)Interventional2015-06-30Completed
Enhanced Recovery After Surgery in Elderly Patients: Effects of Sugammadex on Recovery After Anterior Cervical Spine Surgery [NCT04161508]100 participants (Anticipated)Interventional2019-12-20Not yet recruiting
Best Management of Muscle Relaxation With Rocuronium Using Objective Monitoring and Reversal With Neostigmine or Sugammadex [NCT03958201]Phase 4200 participants (Actual)Interventional2019-05-28Completed
Impact of Sugammadex vs. Neostigmine Reversal on Post-Operative Recovery And Postoperative Complications In Patients With Obstructive Sleep Apnea Undergoing Bariatric Surgery: A Double-Blind, Randomized Controlled Trial [NCT03679611]Phase 4120 participants (Actual)Interventional2019-01-14Completed
Postoperative Urinary Retention in Patients After Noncardiac Surgery and Reversal of Neuromuscular Block by Neostigmine or Sugammadex: A Randomized Controlled Trial [NCT05545280]Phase 4286 participants (Anticipated)Interventional2023-07-31Recruiting
Cerebral Oxygenation and Metabolism After Reversal Of Rocuronium Neuromuscular Blockade In Cases Of Supratentorial Tumors: A Comparative Study Between Sugammadex Versus Neostigmine [NCT02944175]40 participants (Anticipated)Interventional2016-07-31Enrolling by invitation
Effect of Neuromuscular Reversal Agents on Time for Neurological Assessment After Endotracheal Intubation in Critically Ill Patients [NCT05993390]30 participants (Anticipated)Interventional2023-09-11Not yet recruiting
Effect of Sugammadex Compared With Usual Care for Reversal of Neuromuscular Blockade Induced by Rocuronium on Incidence of Residual Blockade at PACU Entry [NCT01479764]Phase 3154 participants (Actual)Interventional2011-12-02Completed
A Comparison of Three Different Doses of Neostigmine on the Reversal of Cisatracurium-induced Moderate Neuromuscular Blockade in Patients Under Sevoflurane or TIVA Anesthesia. [NCT05037006]Phase 490 participants (Anticipated)Interventional2021-10-01Not yet recruiting
Influence of the Neuromuscular Blockade and Its Reversal on Perioperative Arrhythmias [NCT04720573]80 participants (Actual)Interventional2019-06-01Completed
Role of Sugammadex as Reversal Agent in Patients Extubated Immediately After Isolated Coronary Artery Bypass Grafting Surgery [NCT03939923]Phase 484 participants (Actual)Interventional2019-05-01Completed
A Multi-center, Randomized, Parallel Group, Comparative, Active Controlled, Safety-assessor Blinded, Anesthesiologist-TOF-Watch® SX Blinded Trial Comparing T4/T1 Ratio at Time of Tracheal Extubation Using 4 mg/kg Sugammadex Administered at 1-2 PTCs or Bet [NCT00675792]Phase 3100 participants (Actual)Interventional2008-05-31Completed
An Assessor-blinded, Randomized, Controlled, Single Center, Parallel Design Trial With Patient Masking to Compare Early Postoperative Gastric Emptying Associated With Rocuronium Neuromuscular Reversal With Sugammadex Versus Neostigmine in Adults Undergoin [NCT04546672]Phase 4120 participants (Anticipated)Interventional2021-03-16Active, not recruiting
A Randomized Safety-Assessor Blinded Trial Comparing Sugammadex With Neostigmine in Korean Subjects Scheduled for Surgeries Requiring Moderate Neuromuscular Blockade [NCT01050543]Phase 3128 participants (Actual)Interventional2010-02-01Completed
[NCT02939430]40 participants (Anticipated)Interventional2016-11-30Recruiting
Phase 4 Study of Optimal Relaxation With Rocuronium Infusion Followed by Rapid Reliable Reversal With Sugammadex: A Comparison With Conventional Practice [NCT01539044]Phase 449 participants (Actual)Interventional2012-02-29Completed
Randomized, Controlled, Double-blind, Prospective Study, Comparing Different Doses of Neostigmine at Advanced Decurarization . [NCT00847938]Phase 362 participants (Actual)Interventional2009-03-31Completed
Comparative Study of Sugammadex Versus Neostigmine for Reversal of Neuromuscular Blockade in Morbidly Obese Patients Undergoing Weight Loss Surgery.Use of Acceleromyography Monitoring in Adductor Pollicis and Corrugator Supercilii. [NCT01629394]Phase 2/Phase 3120 participants (Anticipated)Interventional2012-01-31Recruiting
The Effect of Sugammadex Versus Neostigmine on Postoperative Pulmonary Complications in Patients 70 Years or Older and Scheduled for 3 Hour or Longer Surgery-A Randomized Controlled Trial [NCT02861131]Phase 4200 participants (Actual)Interventional2017-01-24Completed
The Impact of an Epidural Ropivacaine-Neostigmine Injection for Perineal Analgesia at the End of Labor, on Either Immediate Postpartum Perineal Pain or Development of Chronic Perineal Pain After Vaginal Delivery. [NCT00407290]60 participants Interventional2006-03-31Recruiting
Neostigmine Effect on Gastric Residual Volume on Mechanically Ventilated Patients in the Intensive Care Unit. A Comparative Controlled Study by Ondansetron [NCT05342818]Phase 290 participants (Actual)Interventional2022-04-15Completed
Comparison Between Intraperitoneal Versus Intramuscular Neostigmine on Pattern of Postoperative GIT Motility in Patients Undergoing Laparoscopic Cholecystectomy [NCT03505255]Phase 4160 participants (Anticipated)Interventional2018-09-01Not yet recruiting
Ultrasound Guided Quadratus Lumborum Block Compared to Caudal Bupivacaine/ Neostigmine in Pediatric Lower Abdominal Surgeries, a Randomized Controlled Trial [NCT04720287]Phase 460 participants (Actual)Interventional2021-02-01Completed
Comparison of Rocuronium and Org25969 With Cisatracurium and Neostigmine When Neuromuscular Block is Reversed at Reappearance of T2 [NCT00451100]Phase 384 participants (Actual)Interventional2005-11-10Completed
Comparison of Two Neuromuscular Anesthetics Reversal in Obese Patient Undergoing Bariatric Surgery [NCT01631396]40 participants (Actual)Observational2012-07-31Completed
The Effect of Addition of Neostigmine to Levobupivacaine in Male Patients Receiving Ultrasound Guided Spermatic Cord Block for Postoperative Analgesia in Testicular Sperm Extraction Surgery: [NCT04492319]112 participants (Anticipated)Interventional2020-06-29Enrolling by invitation
Modern Myorelaxation Procedure and Reversal of Neuromuscular Blockade With General Anesthesia for Caesarean Section [NCT01718236]Phase 4500 participants (Actual)Interventional2012-09-30Completed
Recovery From Anesthesia After Robotic Assisted Radical Cystectomy. Two Different Reversal of Neuromuscular Blockade [NCT03144453]Phase 450 participants (Anticipated)Interventional2017-05-02Recruiting
Comparison Between Intra-articular Dexmedetomidine and Neostigmine as Adjuvant Analgesics After Knee Arthroscopy [NCT03212495]Phase 2/Phase 3100 participants (Actual)Interventional2017-08-01Completed
A Prospective, Randomized Controlled Trial Comparing Traditional Methods of Neuromuscular Block Reversal to Sugammadex for Extubation in the Operating Room in ASA 4 and 4E Patients. [NCT01761552]Phase 4130 participants (Anticipated)Interventional2013-08-31Recruiting
Reversal With Sugammadex (BRIDION ®) From Deep Neuromuscular Blockade Induced by Rocuronium in Children: Randomised Clinical Trial of Efficacy and Safety [NCT01809886]Phase 3100 participants (Actual)Interventional2011-10-31Completed
A Non-randomized Experimental Study of Optically Registered Pharmacodynamic Responses During Iontophoresis of Vasoactive Substances to the Skin of Healthy Volunteers [NCT04777383]90 participants (Anticipated)Interventional2019-04-01Recruiting
Sugammadex Reversal VS Neostigmine and Glycopyrrolate Competitive Antagonism of Neuromuscular Blockade for GI-2 Recovery After Bowel Resection: Prospective, Randomized, Triple-blinded Clinical Trial for Quality Improvement [NCT06112353]Phase 4128 participants (Anticipated)Interventional2023-11-30Not yet recruiting
Pulmonary Function, Muscle Strength, Time to Extubation and Quality of Recovery in the Post Anesthesia Care Unit After Reversal of Neuromuscular Blockade With Neostigmine or Sugammadex. [NCT02909439]Phase 480 participants (Actual)Interventional2016-11-30Completed
Use of Neuromuscular Blocking Agents and Neuromuscular Monitoring in 7 Danish Teaching Hospitals - a Cross-sectional Study [NCT02914119]30,430 participants (Actual)Observational [Patient Registry]2016-10-01Completed
Comparison of Quality of Recovery Score (QoR-15) According to Neuromuscular Blocking Reversal Agent in Laparoscopic Cholecystectomy: Sugammadex vs. Neostigmine [NCT04332627]Phase 477 participants (Actual)Interventional2020-02-24Completed
Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine [NCT04407078]40 participants (Actual)Interventional2019-12-02Completed
Comparison of the Effectiveness of Rocuronium - Sugammadex With Succinylcholine-Cisatracurium-Neostigmine in Patients Undergoing Laser Microlaryngeal Surgery [NCT02329964]Phase 480 participants (Actual)Interventional2015-02-28Active, not recruiting
Evaluation of Intrathecal Neostigmine as an Adjuvant to Bupivacaine in Ameliorating Post-Dural Puncture Headache in Elective Caesarian Section: A Prospective Randomized Controlled Clinical Trial [NCT05289323]Phase 4722 participants (Actual)Interventional2022-04-25Completed
The Effect of Deep Neuromuscular Blockade With Sugammadex Reversal on Shoulder Pain of Elderly Patients Undergoing Robotic Surgery: A Single-Center Double-Blinded Randomized Controlled Trial [NCT03210376]Phase 4100 participants (Actual)Interventional2017-11-17Completed
Can we Antagonize Mivacurium With Neostigmine [NCT03019835]80 participants (Actual)Interventional2016-12-31Completed
A Prospective, Randomized, Double-Blind Clinical Trial Evaluating the Speed of Recovery and Safety of Reversal of Neuromuscular Blockade With Sugammadex (Bridion™) Versus Neostigmine in Geriatric Patients Undergoing Spine Surgery [NCT03112993]Phase 440 participants (Actual)Interventional2017-05-30Completed
Reversal of Neuromuscular Blockade in Patients With Severe Renal Impairment [NCT03904550]Phase 249 participants (Actual)Interventional2019-12-10Completed
Effect of Deep Curarisation and Reversal With Sugammadex on Surgical Conditions and Perioperative Morbidity in Patients Undergoing Laparoscopic Gastric Bypass Surgery [NCT01748643]Phase 460 participants (Actual)Interventional2013-04-30Completed
Sugammadex Versus Neostigmine for Antagonism of Rocuronium-induced Neuromuscular Blockade in Patients With Liver Cirrhosis Undergoing Liver Resection: A Controlled Randomized Study [NCT02414880]Phase 460 participants (Actual)Interventional2014-12-31Completed
Feasibility of Neostigmine as a Reversal Agent of Neuromuscular Blockade for Intraoperative Neuromonitoring During Thyroid Surgery: a Prospective Randomized Controlled Study [NCT04873531]44 participants (Actual)Interventional2021-05-10Completed
Street Fitness in Surgical Patients Undergoing General Anesthesia After Reversal of Neuromuscular Rest Blockade With Sugammadex [NCT01453530]Phase 430 participants (Anticipated)Interventional2011-10-31Recruiting
The Early Reversibility of Rocuronium After Different Doses of Neostigmine [NCT00001520]Phase 460 participants Interventional1996-09-30Completed
A Randomized, Blinded-assessor, Single Center Study to Determine if Administration of Sugammadex, When Used to Reverse Deep Neuromuscular Blockade (NMB) After Open Abdominal Surgery, Impacts Hospital Efficiency [NCT02860507]Phase 450 participants (Actual)Interventional2016-08-31Completed
Sugammadex Versus Neostigmine for Reversal of Rocuronium-induced Neuromuscular Blockade: A Study of Thoracic Surgical Patients [NCT03168308]Phase 492 participants (Actual)Interventional2017-09-26Completed
Sugammadex Versus Neostigmine for Reversal of Rocuronium Neuromuscular Block in Patients Having Catheter-based Neurointerventional Procedures [NCT03322657]Phase 469 participants (Actual)Interventional2017-11-14Completed
Effects of Neuromuscular Block Reversal With Sugammadex vs Neostigmine on Postoperative Respiratory Outcomes After Major Abdominal Surgery - A Randomized Controlled Trial [NCT02361060]Phase 4130 participants (Actual)Interventional2015-02-28Completed
Comparison the Postoperative Quality of Recovery Between Neostigmine and Sugammadex in Elderly Patients Undergoing Trans Pars Plana Vitrectomy With General Anesthesia -Randomized Controlled Trial- [NCT03108989]90 participants (Actual)Interventional2017-02-08Completed
The Effectiveness of Neostigmine on the Recovery of Rocuronium-Induced Neuromuscular Blockade: A Comparison Between Partial Dose and TOF Ratio-Based Adjustment Dose [NCT03058263]Phase 1/Phase 266 participants (Actual)Interventional2016-10-31Completed
Sugammadex and the Diaphragm: Recovery of Diaphragmatic Function and Neuromuscular Blockade. A Double-blind Randomized Controlled Trial [NCT01962298]Phase 375 participants (Actual)Interventional2013-10-31Completed
[NCT02370433]Phase 120 participants (Anticipated)Interventional2012-12-31Recruiting
Use of Sugammadex for Reversal of Paralysis in Microlaryngoscopy [NCT03111121]Phase 484 participants (Anticipated)Interventional2017-05-04Recruiting
Intraoperative Lidocaine Infusion vs. Esmolol Infusion for Postoperative Analgesia in Laparoscopic Cholecystectomy: a Randomized Clinical Trial [NCT02327923]Phase 490 participants (Actual)Interventional2015-01-31Completed
The Curative Effect and Security of Neostigmine Treatment of Acute Pancreatitis Combined With Intra-abdominal Hypertension [NCT02543658]Phase 280 participants (Actual)Interventional2015-09-01Completed
Intramuscular Neostigmine for Accelerating Bladder Emptying After Cesarean Section by Spinal Anesthesia [NCT04364607]Phase 4100 participants (Actual)Interventional2020-08-05Completed
A Comparative Study Between Neostigmine and Dexamethasone as an Adjuvant to Bupivacaine in Adductor Canal Block After Knee Arthroscopy Surgery [NCT04565301]90 participants (Actual)Interventional2021-06-20Completed
Efficacy of Neostigmine Versus Dexamethasone as Adjuvants to Lidocaine During Intravenous Local Anesthesia for Forearm Orthopedic Surgeries [NCT03021772]Phase 2/Phase 360 participants (Actual)Interventional2017-01-31Completed
Evaluating the Safety and Efficacy of Different Routes of Neostigmine Administration for Acute Colonic Pseudo Obstruction: a Prospective Randomized Trial [NCT04951726]Phase 490 participants (Anticipated)Interventional2022-02-04Recruiting
Comparison of Reversal of Neuromuscular Blockade With Sugammadex Versus Neostigmine Plus Glycopyrolate in Patients Undergoing Burn Surgery [NCT03513406]Phase 37 participants (Actual)Interventional2018-03-15Completed
Reversal of Neuromuscular Blockade in Thoracic Surgical Patients [NCT01837498]200 participants (Actual)Observational2014-02-28Completed
Comparative Effects of Nebulized Dexmedetomidine Versus Neostigmine / Atropine in Treating Postdural Puncture Headache After Cesarean Section: A Double Blind Randomized Clinical Trial [NCT04910477]Phase 390 participants (Actual)Interventional2021-06-01Completed
Comparison Of Different Doses Of Intrathecal Neostigmine In Prevention Of Post-Dural Puncture Headache: Prospective, Randomized, Controlled, Triple-blinded Trial [NCT04905953]Phase 2/Phase 3274 participants (Anticipated)Interventional2021-02-01Recruiting
The Reversal of Residual Neuromuscular Blockade After Neostigmine and Half-dose Sugammadex: A Comparison With Standard Reversal of Full-dose Neostigmine [NCT05066035]Phase 4113 participants (Actual)Interventional2013-05-01Completed
Effect of Anesthetic Choice (Sevoflurane Versus Desflurane) on Speed and Sustained Nature of Airway Reflex Recovery in the Context of Antagonized Neuromuscular Block [NCT01199237]Phase 4107 participants (Actual)Interventional2010-08-31Completed
A Randomized, Controlled, Parallel-group, Double-blind Trial of Sugammadex or Usual Care (Neostigmine or Spontaneous Recovery) for Reversal of Rocuronium- or Vecuronium-induced Neuromuscular Blockade in Patients Receiving Thromboprophylaxis and Undergoing [NCT01422304]Phase 31,198 participants (Actual)Interventional2011-10-12Completed
Effects of the Addition of a Prokinetic Agent to Thrice Weekly Bowel Care in Individuals With SCI [NCT04671030]Phase 16 participants (Actual)Interventional2018-01-15Completed
Diaphragm and Lung Ultrasound After Reversal of Rocuronium-induced Neuromuscular Blockade With Sugammadex or Neostigmine in Children Undergoing Surgery : A Randomized Double-blind Controlled Trial [NCT05724550]82 participants (Anticipated)Interventional2023-02-22Recruiting
Pharmacokinetic-pharmacodynamic Analysis of Conventional Reversal of Rocuronium-induced Neuromuscular Blockade by Sugammadex in Children [NCT04347486]Phase 232 participants (Actual)Interventional2020-04-29Completed
Study on Correlation Between Cytomegalovirus and Ocular Myasthenia Gravis [NCT05091177]125 participants (Anticipated)Observational [Patient Registry]2021-01-01Recruiting
Deep Neuromuscular Block During General Anaesthesia in Laparoscopic (and Robotic Laparoscopic) Surgery and Its Potential Benefits for Certain Physiological Parameters in Perioperative Period [NCT03420937]Phase 4138 participants (Actual)Interventional2016-06-30Completed
Postoperative Urinary Retention After Reversal of Neuromuscular Block by Neostigmine Versus Sugammadex in Patients Undergoing Laparoscopic Cholecystectomy: A Randomized Controlled Trial [NCT05794503]Early Phase 1230 participants (Anticipated)Interventional2023-09-11Recruiting
Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine [NCT03583021]42 participants (Actual)Interventional2018-06-25Completed
[NCT02109133]67 participants (Actual)Interventional2014-05-31Completed
A Double-blind, Randomized, Parallel Group Study to Compare Rocuronium Reversal With Sugammadex (Bridion®) Versus Neostigmine/Glycopyrrolate and the Incidence of Urinary Retention After Elective Ambulatory Posterior Lumbar Laminectomy [NCT05887375]Phase 4118 participants (Anticipated)Interventional2023-08-03Enrolling by invitation
Local Neostigmine for Treatment of Snoring During Drug-Induced Sleep Endoscopy [NCT03316963]Early Phase 11 participants (Actual)Interventional2017-11-14Terminated(stopped due to PI is moving the a new institution and ended the study early.)
Comparative Effect of Neuromuscular Blockade Reversal Agent on Extubation Conditions, Postoperative Cognitive Function and Behaviour of School-aged Children Undergoing Ear Note Throat (ENT) Surgery [NCT02455921]Phase 4200 participants (Actual)Interventional2015-06-30Completed
Effect of Deep Neuromuscular Blockade on Surgical Conditions and Recovery After Robotic Radical Prostatectomy: a Prospective Randomized Study [NCT02513693]Phase 480 participants (Anticipated)Interventional2015-07-31Recruiting
[NCT02454504]120 participants (Actual)Interventional2015-03-31Completed
A Randomized Clinical Study to Compare Low Dose of Sugammadex to Standard Dose of Neostigmine and Glycopyrrolate for the Reversal of Rocuronium Induced Moderate Neuromuscular Block [NCT05718934]Phase 4144 participants (Anticipated)Interventional2022-11-08Recruiting
"Randomized, Parallel Group, Controlled Trial to Compare Two Different NMB + Reversal Strategies in Adult Obese Patients Undergoing Laparoscopic Abdominal Surgery" [NCT02410590]Phase 40 participants (Actual)Interventional2015-07-31Withdrawn
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT00451217 (5) [back to overview]Time From Start of Administration of Sugammadex or Neostigmine to Recovery of the T4/T1 Ratio to 0.7
NCT00451217 (5) [back to overview]Time From Start of Administration of Sugammadex or Neostigmine to Recovery of the Fourth Twitch/First Twitch (T4/T1) Ratio to 0.9.
NCT00451217 (5) [back to overview]Number of Participants With Clinical Signs of Recovery Assessed by Level of Consciousness, Head Lift and Muscle Weakness, Prior to Transfer to the Recovery Room After Extubation
NCT00451217 (5) [back to overview]Time From Start of Administration of Sugammadex or Neostigmine to Recovery of the T4/T1 Ratio to 0.8
NCT00451217 (5) [back to overview]Number of Participants With Clinical Signs of Recovery Assessed by Level of Consciousness, Head Lift and Muscle Weakness, Prior to Discharge From the Recovery Room
NCT00473694 (11) [back to overview]Number of Participants Responsive Only to Tactile Stimulation After Anesthesia (Clinical Assessment of Level of Consciousness)
NCT00473694 (11) [back to overview]Number of Participants Awake and Oriented After Anesthesia (Clinical Assessment of Level of Consciousness)
NCT00473694 (11) [back to overview]Number of Participants Aroused With Minimal Stimulation After Anesthesia (Clinical Assessment of Level of Consciousness)
NCT00473694 (11) [back to overview]Number of Participants Experiencing General Muscle Weakness
NCT00473694 (11) [back to overview]Time From Start of Administration of Sugammadex or Neostigmine to Recovery of the T4/T1 Ratio to 0.7 After Neuromuscular Block (NMB) Induced by Rocuronium
NCT00473694 (11) [back to overview]Time From Start of Administration of Sugammadex or Neostigmine to Recovery of the T4/T1 Ratio to 0.7 After Neuromuscular Block (NMB) Induced by Vecuronium
NCT00473694 (11) [back to overview]Time From Start of Administration of Sugammadex or Neostigmine to Recovery of the T4/T1 Ratio to 0.8 After Neuromuscular Block (NMB) Induced by Rocuronium
NCT00473694 (11) [back to overview]Time From Start of Administration of Sugammadex or Neostigmine to Recovery of the T4/T1 Ratio to 0.8 After Neuromuscular Block (NMB) Induced by Vecuronium
NCT00473694 (11) [back to overview]Time From Start of Administration of Sugammadex or Neostigmine to Recovery of the T4/T1 Ratio to 0.9 After Neuromuscular Block (NMB) Induced by Rocuronium
NCT00473694 (11) [back to overview]Time From Start of Administration of Sugammadex or Neostigmine to Recovery of the T4/T1 Ratio to 0.9 After Neuromuscular Block (NMB) Induced by Vecuronium
NCT00473694 (11) [back to overview]Number of Participants Able to Perform a 5-second Head Lift
NCT00675792 (6) [back to overview]Number of Participants With Evidence of Possible Interaction of Sugammadex With Endogenous Compounds or Exogenous Compounds Other Than Rocuronium Bromide
NCT00675792 (6) [back to overview]Number of Participants With Post-operative Complications
NCT00675792 (6) [back to overview]Residual Neuromuscular Blockade Evidenced by T4/T1 Ratio at the Time of Tracheal Extubation
NCT00675792 (6) [back to overview]Time From Start of Administration of IMP to Recovery of the T4/T1 Ratio to 0.8
NCT00675792 (6) [back to overview]Time From Start of Administration of Investigational Medicinal Product (IMP) to Recovery of the T4/T1 Ratio to 0.9
NCT00675792 (6) [back to overview]Time From Start of Administration of IMP to Recovery of the T4/T1 Ratio to 0.7
NCT00724932 (32) [back to overview]Mean Heart Rate
NCT00724932 (32) [back to overview]Mean Diastolic Blood Pressure
NCT00724932 (32) [back to overview]Time From Tracheal Extubation to Operating Room Discharge Ready
NCT00724932 (32) [back to overview]Time From Tracheal Extubation to Actual Operating Room Discharge
NCT00724932 (32) [back to overview]Time From Start of IMP Administration to Tracheal Extubation
NCT00724932 (32) [back to overview]Time From Start of IMP Administration to Operating Room Discharge Ready
NCT00724932 (32) [back to overview]Time From Start of Administration of the Last Dose of Rocuronium to the Time of Reappearance of T2 in the 50 μg.Kg-1 Neostigmine Group
NCT00724932 (32) [back to overview]Time From Start of Administration of the Last Dose of Rocuronium to the Time of 1-2 PTC in the 4.0 mg.Kg-1 Sugammadex Group
NCT00724932 (32) [back to overview]Time From Start of Administration of Investigational Medicinal Product (IMP, Sugammadex or Neostigmine) to Recovery of the Fourth Twitch/First Twitch (T4/T1) Ratio to 0.9
NCT00724932 (32) [back to overview]Time From Start of Administration of IMP to Recovery of the T4/T1 Ratio to 0.8
NCT00724932 (32) [back to overview]Time From Start of Administration of IMP to Recovery of the T4/T1 Ratio to 0.7
NCT00724932 (32) [back to overview]Time From PACU Admit to PACU Discharge Ready
NCT00724932 (32) [back to overview]Number of Participants With Reoccurrence of Neuromuscular Blockade Based on the Train-of-Four- (TOF-) Watch® SX Recording (i.e. a Decline in T4/T1 Ratio From >=0.9 to <0.8 in at Least Three Consecutive TOF Values)
NCT00724932 (32) [back to overview]Time From Operating Room Discharge Ready to Post Anesthetic Care Unit (PACU) Discharge Ready
NCT00724932 (32) [back to overview]Time From Operating Room Discharge Ready to Actual PACU Discharge
NCT00724932 (32) [back to overview]Time From Operating Room Discharge Ready to Actual Operating Room Discharge
NCT00724932 (32) [back to overview]Time From PACU Admit to Actual PACU Discharge
NCT00724932 (32) [back to overview]Time From Operating Room Admission to Operating Room Discharge Ready
NCT00724932 (32) [back to overview]Time From Operating Room Admission to Actual Operating Room Discharge
NCT00724932 (32) [back to overview]Monitoring of Clinical Signs of Recovery According to Routine Anesthetic Procedures at the Trial Sites
NCT00724932 (32) [back to overview]Number of Participants With Clinical Evidence of Reoccurrence of Neuromuscular Blockade or Residual Neuromuscular Blockade (Routine Oxygen Saturation by Pulse Oximetry and Breath Frequency Measurement)
NCT00724932 (32) [back to overview]Time From Start of Administration of the Last Dose of Rocuronium to Recovery of the T4/T1 Ratio to 0.5, 0.6, 0.7, 0.8 and 0.9
NCT00724932 (32) [back to overview]Time From Start of Administration of IMP to Recovery of the T4/T1 Ratio to 0.5 and 0.6
NCT00724932 (32) [back to overview]Time From Start of IMP Administration to Actual Operating Room Discharge
NCT00724932 (32) [back to overview]Number of Participants Who Experienced Pre-treatment Serious Adverse Events (SAEs) and Post-treatment SAEs
NCT00724932 (32) [back to overview]Number of Participants Who Experienced Pre-treatment Non-serious Adverse Events (AEs) and Post-treatment Non-serious AEs
NCT00724932 (32) [back to overview]Time From Actual Operating Room Discharge to PACU Discharge Ready
NCT00724932 (32) [back to overview]Number of Participants With Events Due to a Possible Interaction of Sugammadex With Endogenous Compounds or With Exogenous Compounds Other Than Rocuronium
NCT00724932 (32) [back to overview]Number of Participants With Train-of-Four- (TOF-) Watch® SX and Arm Board Related Adverse Events
NCT00724932 (32) [back to overview]Time From Actual Operating Room Discharge to Actual PACU Discharge
NCT00724932 (32) [back to overview]Mean Systolic Blood Pressure
NCT00724932 (32) [back to overview]Number of Female Participants or Partners of Male Participants Who Became Pregnant During Study
NCT00745095 (2) [back to overview]Polyp Detection
NCT00745095 (2) [back to overview]Quality of Bowel Preparation
NCT00779467 (8) [back to overview]Shivering
NCT00779467 (8) [back to overview]Patient Satisfaction Scores
NCT00779467 (8) [back to overview]Pruritus
NCT00779467 (8) [back to overview]Amount of Drug Consumed Per Hour in Each Group(Arm)
NCT00779467 (8) [back to overview]Bromage Score
NCT00779467 (8) [back to overview]Cesarean Delivery
NCT00779467 (8) [back to overview]Nausea
NCT00779467 (8) [back to overview]Sedation
NCT00825812 (2) [back to overview]Time From Start of Administration of IMP to Recovery of the T4/T1 Ratio to 0.7 and 0.8.
NCT00825812 (2) [back to overview]Time From Start of Administration of Investigational Medicinal Product (IMP) to Recovery of the T4/T1 Ratio to 0.9.
NCT00847938 (1) [back to overview]Mesure of the Train-of-four (TOF)
NCT01050543 (1) [back to overview]Time From Start of Study Drug Administration to Recovery of the T4/T1 Ratio to 0.9
NCT01199237 (5) [back to overview]Nausea and Vomiting
NCT01199237 (5) [back to overview]Nausea and Vomiting
NCT01199237 (5) [back to overview]Time From Potent Inhaled Anesthetic Discontinuation to First Response to Command (T1)
NCT01199237 (5) [back to overview]Time From Anesthetic Discontinuation to First Ability to Swallow
NCT01199237 (5) [back to overview]Recovery of Ability to Swallow After Neostigmine/Glycopyrrolate Antagonism of Rocuronium Paralysis.
NCT01422304 (13) [back to overview]Number of Participants Requiring Any Postoperative Transfusion
NCT01422304 (13) [back to overview]Number of Participants With One or More Adjudicated Events of Anaphylaxis With Onset Within 14 Days After Study Drug Administration
NCT01422304 (13) [back to overview]Number of Participants With One or More Adjudicated Events of Bleeding (Major or Non-major) With Onset Within 14 Days After Study Drug Administration
NCT01422304 (13) [back to overview]Number of Participants With One or More Adjudicated Events of Bleeding (Major or Non-major) With Onset Within 24 Hours After Study Drug Administration
NCT01422304 (13) [back to overview]Number of Participants With One or More Adjudicated Major Events of Bleeding With Onset Within 14 Days After Study Drug Administration
NCT01422304 (13) [back to overview]Number of Participants With One or More Adjudicated Major Events of Bleeding With Onset Within 24 Hours After Study Drug Administration
NCT01422304 (13) [back to overview]Number of Participants With One or More Adjudicated Venous Thromboembolic (VTE) Events With Onset Within 14 Days After Study Drug Administration
NCT01422304 (13) [back to overview]Number of Participants With One or More Postoperative Anemia Adverse Events With Onset Within 72 Hours After Study Drug Administration
NCT01422304 (13) [back to overview]Postoperative Changes in Hgb Concentrations Using the Bleeding Index
NCT01422304 (13) [back to overview]Postoperative Drainage Volume Within 24 Hours After Study Drug Administration
NCT01422304 (13) [back to overview]Total Transfusion Volume in Participants Who Required Postoperative Transfusion
NCT01422304 (13) [back to overview]Percent Change From Baseline in Activated Partial Thromboplastin Time (aPTT) at 10 and 60 Minutes Post Study Drug Administration
NCT01422304 (13) [back to overview]Percent Change From Baseline in Prothrombin Time (International Normalized Ratio) (PT[INR]) at 10 and 60 Minutes Post Study Drug Administration
NCT01479764 (2) [back to overview]Incidence of Residual Neuromuscular Blockade (NMB) as Defined by a Train-of-Four (TOF) Ratio <0.9 at Post Anesthesia Care Unit (PACU) Entry
NCT01479764 (2) [back to overview]Time From Start of Study Drug Administration to Operating Room Discharge-ready
NCT01748643 (6) [back to overview]Number of Intra-abdominal Pressure Rises > 18cmH2O
NCT01748643 (6) [back to overview]Peak Expiratory Flow
NCT01748643 (6) [back to overview]Subjective Evaluation of the View on the Operating Field by the Surgeon
NCT01748643 (6) [back to overview]Duration of Surgery
NCT01748643 (6) [back to overview]Forced Expiratory Volume in 1 Second
NCT01748643 (6) [back to overview]Forced Vital Capacity
NCT01962298 (2) [back to overview]Electric Activity of the Diaphragm (Microvolts)
NCT01962298 (2) [back to overview]Electric Activity of the Intercostal Muscles
NCT02109133 (4) [back to overview]Overall Surgical Condition
NCT02109133 (4) [back to overview]Post-operative Nausea
NCT02109133 (4) [back to overview]Incidence of Residual Neuromuscular Blockade
NCT02109133 (4) [back to overview]Maximum Intraocular Pressure During RALRP Under Deep Neuromuscular Blockade
NCT02243943 (3) [back to overview]Mean Lowest Saturation
NCT02243943 (3) [back to overview]Pain
NCT02243943 (3) [back to overview]Sedation
NCT02329964 (9) [back to overview]Time to Extubation
NCT02329964 (9) [back to overview]Time to Eye Opening
NCT02329964 (9) [back to overview]Time to First Spontaneous Breath
NCT02329964 (9) [back to overview]Recovery of T1 to 90%
NCT02329964 (9) [back to overview]Addition of Neuromuscular Blocking Agents
NCT02329964 (9) [back to overview]Anesthesia Time
NCT02329964 (9) [back to overview]Length of Stay in te Operating Room
NCT02329964 (9) [back to overview]Recovery of T1 to 10%
NCT02329964 (9) [back to overview]Surgical Rating Score
NCT02330172 (2) [back to overview]Recovery Time From Neuromuscular Blockade
NCT02330172 (2) [back to overview]Laryngoscopic Score
NCT02543658 (11) [back to overview]Death of 90 Days
NCT02543658 (11) [back to overview]Medical Expenses
NCT02543658 (11) [back to overview]New-onset Abdominal Compartment Syndrom
NCT02543658 (11) [back to overview]Number of Participants With Adverse Effects on the Cardiovascular System
NCT02543658 (11) [back to overview]Number of Participants With Deterioration of IAH
NCT02543658 (11) [back to overview]Timing of Enteral Nutrition
NCT02543658 (11) [back to overview]Percent Change of IAP After Treatment
NCT02543658 (11) [back to overview]The Change of Stool Volume at 1-7 Days After Randomization
NCT02543658 (11) [back to overview]New-onset Organ Failure
NCT02543658 (11) [back to overview]Days in Hospital
NCT02543658 (11) [back to overview]Days in ICU
NCT02845375 (2) [back to overview]Breathing Increase Due to a Reduction in Inspired Oxygen Saturation (Hypoxic Ventilatory Response)
NCT02845375 (2) [back to overview]Breathing Increase Due to a Reduction in Inspired Oxygen Saturation (Hypoxic Ventilatory Response)
NCT02860507 (2) [back to overview]Number of Patients Who Experience Postoperative Nausea and Vomiting, Post-operative Pain, and Post-operative Complications
NCT02860507 (2) [back to overview]Operating Room (OR) Turnover Time When Using Sugammadex Instead of Combination of Neostigmine and Glycopyrrolate.
NCT02861131 (6) [back to overview]Hospital Length of Stay
NCT02861131 (6) [back to overview]Number of Participants With Residual Neuromuscular Blockade in the PACU
NCT02861131 (6) [back to overview]PACU Phase 1 Recovery Time
NCT02861131 (6) [back to overview]Number of Participants Diagnosed With a National Surgical Quality Improvement Program (NSQIP) Defined Respiratory Complication
NCT02861131 (6) [back to overview]Number of Participants With a Postoperative Pulmonary Complication
NCT02861131 (6) [back to overview]Number of Participants With Hospital Readmission Within 30 Days
NCT02909439 (10) [back to overview]Time to Readiness for Post Anesthesia Care Unit (PACU) Discharge (Aldrete Score >9)
NCT02909439 (10) [back to overview]Train of Four Ratio > 90% During PACU Admission
NCT02909439 (10) [back to overview]Grip Strength, Change From Baseline and Recovery Profile 120 Min
NCT02909439 (10) [back to overview]Grip Strength, Change From Baseline and Recovery Profile 30 Min
NCT02909439 (10) [back to overview]Grip Strength, Change From Baseline and Recovery Profile 60 Min
NCT02909439 (10) [back to overview]Incentive Spirometry, Change From Baseline and Recovery Profile - 120 Minutes
NCT02909439 (10) [back to overview]Incentive Spirometry, Change From Baseline and Recovery Profile - 30 Minutes
NCT02909439 (10) [back to overview]Incentive Spirometry, Change From Baseline and Recovery Profile - 60 Minutes
NCT02909439 (10) [back to overview]Quality of Recovery 15 Survey
NCT02909439 (10) [back to overview]Time to Extubation
NCT02914119 (2) [back to overview]Last Recorded Train-of-four (TOF) Ratio Before Tracheal Extubation or Removal of Supraglottic Airway Device in Patients Receiving a Non-depolarizing NMBA
NCT02914119 (2) [back to overview]Time in Minutes From Tracheal Extubation or Removal of Supraglottic Airway Device to Discharge From Post-anaesthesia Care Unit in Cases Involving a Non-depolarizing NMBA With and Without Neuromuscular Monitoring, Respectively
NCT03034577 (6) [back to overview]Number of Participants With Full Reversal of Neuromuscular Blockade Prior to Extubation
NCT03034577 (6) [back to overview]Duration of Hospital Length of Stay
NCT03034577 (6) [back to overview]Percentage of Patients Recovered Cognitively at 1 Week
NCT03034577 (6) [back to overview]Percentage of Patients Recovered in All Domains of the Postoperative Quality of Recovery Scale at 3 Months After the Operation
NCT03034577 (6) [back to overview]Duration of Anesthesia From Induction to Cessation of the Anesthetic
NCT03034577 (6) [back to overview]Number of Participants Categorized by Level of Surgical Satisfaction
NCT03112993 (5) [back to overview]Difference in Length of Stay in PACU
NCT03112993 (5) [back to overview]Difference in Time From Neuromuscular Reversal to Exit From OR
NCT03112993 (5) [back to overview]Difference in Time of Neuromuscular Recovery From a Neuromuscular Moderate Blockade
NCT03112993 (5) [back to overview]Difference in Time to First Ambulation After Surgery
NCT03112993 (5) [back to overview]Difference in Time From Neuromuscular Reversal to Tracheal Extubation
NCT03116997 (1) [back to overview]Measure Participants' Recovery Time Post-Surgery
NCT03138967 (3) [back to overview]PostOperative Complications
NCT03138967 (3) [back to overview]Overall Recovery Time
NCT03138967 (3) [back to overview]Muscle Recovery Time
NCT03168308 (3) [back to overview]Time to Complete Reversal of Neuromuscular Blockade
NCT03168308 (3) [back to overview]Number of Hypoxic Episodes
NCT03168308 (3) [back to overview]Number of Participants Who Needed Rescue Sugammadex After Initial Reversal of Neuromuscular Blockade
NCT03210376 (7) [back to overview]Percentage of Participants With Nausea and/or Vomiting in PACU
NCT03210376 (7) [back to overview]Readiness to Discharge From the Post-Anesthesia Care Unit (PACU)
NCT03210376 (7) [back to overview]Surgical Exposure Grading
NCT03210376 (7) [back to overview]Cumulative Intraoperative Insufflation Pressure
NCT03210376 (7) [back to overview]Length of Hospital Stay
NCT03210376 (7) [back to overview]Percentage of Muscle Response Using Train-of-Four (TOF) in Post-Anesthesia Care Unit (PACU) to Measure Residual Muscle Relaxation
NCT03210376 (7) [back to overview]Percentage of Patients Who Reported Shoulder Pain
NCT03229486 (7) [back to overview]Pediatric Anesthesia Emergence Delirium Score
NCT03229486 (7) [back to overview]Time to Regular Breathing
NCT03229486 (7) [back to overview]Time to Awakening
NCT03229486 (7) [back to overview]Time Recovery of TOF Ratio to 0.9
NCT03229486 (7) [back to overview]Time Recovery of TOF Ratio to 0.8
NCT03229486 (7) [back to overview]Time Recovery of TOF Ratio to 0.7
NCT03229486 (7) [back to overview]Time to Extubation
NCT03276026 (1) [back to overview]Post Anesthesia Care Unit Length of Stay
NCT03322657 (5) [back to overview]Change of Diaphragmatic Contractility Speed, Deep Breathing From Mouth, cm/s
NCT03322657 (5) [back to overview]The Time for Extubation After Administration of Reversal Agents
NCT03322657 (5) [back to overview]TOF Ratio at 90 Min
NCT03322657 (5) [back to overview]Time in Minutes to Reach Train of Four (TOF) Ratio ≥ 0.9 After the Administration of Reversal Agent
NCT03322657 (5) [back to overview]Change of Diaphragmatic Contractility Speed- Sniff (Breathing From the Nose), cm/s
NCT03346057 (6) [back to overview]Percentage of Participants With Treatment-Emergent Sinus Bradycardia Events
NCT03346057 (6) [back to overview]Percentage of Participants Experiencing a Serious Adverse Event (SAE) Up To 7 Days After Administration of Study Intervention
NCT03346057 (6) [back to overview]Percentage of Participants With Treatment-Emergent Sinus Tachycardia Events
NCT03346057 (6) [back to overview]Percentage of Participants Experiencing an Event of Clinical Interest (ECI) Up To 7 Days After Administration of Study Intervention
NCT03346057 (6) [back to overview]Percentage of Participants With Other Treatment-Emergent Cardiac Arrhythmia Events
NCT03346057 (6) [back to overview]Percentage of Participants Experiencing an Adverse Event (AE) Up To 7 Days After Administration of Study Intervention
NCT03346070 (11) [back to overview]Time to Recovery (TTR) of Participant Train of Four (TOF) Ratio to ≥0.8: Geometric Mean Analysis
NCT03346070 (11) [back to overview]Time to Recovery (TTR) of Participant Train Of Four (TOF) Ratio to ≥0.9: Primary Kaplan-Meier Analysis
NCT03346070 (11) [back to overview]Percentage of Participants With Prolonged (>10 Minutes) Time to Recovery (TTR) of the Train Of Four (TOF) Ratio to ≥0.9
NCT03346070 (11) [back to overview]Percentage of Participants With Other Treatment-Emergent Cardiac Arrhythmia Events
NCT03346070 (11) [back to overview]Percentage of Participants Experiencing a Serious Adverse Event (SAE) After Administration of Study Intervention
NCT03346070 (11) [back to overview]Percentage of Participants With Treatment-Emergent Sinus Bradycardia Events
NCT03346070 (11) [back to overview]Percentage of Participants With Treatment-Emergent Sinus Tachycardia Events
NCT03346070 (11) [back to overview]Time to Recovery (TTR) of Participant Train of Four (TOF) Ratio to ≥0.7: Geometric Mean Analysis
NCT03346070 (11) [back to overview]Time to Recovery (TTR) of Participant Train of Four (TOF) Ratio to ≥0.9: Secondary Geometric Mean Analysis
NCT03346070 (11) [back to overview]Percentage of Participants Experiencing an Event of Clinical Interest (ECI) After Administration of Study Intervention
NCT03346070 (11) [back to overview]Percentage of Participants Experiencing an Adverse Event (AE) After Administration of Study Intervention
NCT03351608 (9) [back to overview]Apparent Volume of Distribution (Vz) of Sugammadex [Part A]
NCT03351608 (9) [back to overview]Time to Recovery of Participant Train-of-Four (TOF) Ratio to ≥0.9 [Part B]
NCT03351608 (9) [back to overview]Time to Recovery of Participant TOF Ratio to ≥0.8 [Part B]
NCT03351608 (9) [back to overview]Time to Recovery of Participant TOF Ratio to ≥0.7 [Part B]
NCT03351608 (9) [back to overview]Plasma Half-Life (t½) of Sugammadex [Part A]
NCT03351608 (9) [back to overview]Plasma Clearance (CL) of Sugammadex [Part A]
NCT03351608 (9) [back to overview]Percentage of Participants With ≥1 Adverse Event (AE) [Parts A and B]
NCT03351608 (9) [back to overview]Maximum Plasma Concentration (Cmax) of Sugammadex [Part A]
NCT03351608 (9) [back to overview]Area Under the Plasma Concentration-Time Curve (AUC) From Dosing to Infinity (AUC0-∞) of Sugammadex [Part A]
NCT03904550 (1) [back to overview]Time Until Complete Reversal of Neuromuscular Blockade
NCT03939923 (5) [back to overview]Tidal Volume
NCT03939923 (5) [back to overview]Peak Flow Rate
NCT03939923 (5) [back to overview]Blood Pressure (First Measurement of Systolic Blood Pressure Post Reversal)
NCT03939923 (5) [back to overview]Time to Extubation
NCT03939923 (5) [back to overview]Heart Rate
NCT03943888 (3) [back to overview]Plasma Concentrations
NCT03943888 (3) [back to overview]Plasma Concentrations
NCT03943888 (3) [back to overview]Neuromuscular Recovery
NCT03958201 (2) [back to overview]Incidence of Postoperative Residual Neuromuscular Blockade at Time of Extubation
NCT03958201 (2) [back to overview]Incidence of Severe Postoperative Residual Neuromuscular Blockade at Time of Extubation

Time From Start of Administration of Sugammadex or Neostigmine to Recovery of the T4/T1 Ratio to 0.7

Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the amplitudes (heights) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB. A faster time to recovery of the T4/T1 Ratio to 0.7 indicates a faster recovery from NMB. (NCT00451217)
Timeframe: Day 1: From start of sugammadex or neostigmine administration to recovery of T4/T1 ratio to 0.7

InterventionMinutes (Mean)
Rocuronium + Sugammadex1.17
Rocuronium + Neostigmine9.60
Vecuronium + Sugammadex1.68
Vecuronium + Neostigmine9.52

[back to top]

Time From Start of Administration of Sugammadex or Neostigmine to Recovery of the Fourth Twitch/First Twitch (T4/T1) Ratio to 0.9.

Neuromuscular functioning was monitored by applying repetitive Train-Of-Four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the amplitudes (heights) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from neuromuscular blockade (NMB). In this study, twitch responses were recorded until the T4/T1 Ratio reached >= 0.9, the minimum acceptable ratio that indicated recovery from NMB. A faster time to recovery of the T4/T1 Ratio to 0.9 indicates a faster recovery from NMB. (NCT00451217)
Timeframe: Day 1: From start of sugammadex or neostigmine administration to recovery of T4/T1 ratio to 0.9

InterventionMinutes (Mean)
Rocuronium + Sugammadex1.62
Rocuronium + Neostigmine26.78
Vecuronium + Sugammadex4.47
Vecuronium + Neostigmine23.43

[back to top]

Number of Participants With Clinical Signs of Recovery Assessed by Level of Consciousness, Head Lift and Muscle Weakness, Prior to Transfer to the Recovery Room After Extubation

After anesthesia and prior to transfer to the recovery room after extubation, neuromuscular recovery was assessed by monitoring every 15 minutes the following clinical signs of recovery: level of consciousness (i.e., awake and oriented, arousable with minimal stimulation, responsive only to tactile stimulation); 5-second head lift test (ability to lift the head for 5 seconds); and general muscle weakness (NCT00451217)
Timeframe: Day 1

,,,
InterventionParticipants (Count of Participants)
Consciousness: Awake and orientedConsciousness: Arousable with minimal stimulationConsciousness: Responsive only to tactile stimuliAble to perform the 5 second head liftHas general muscle weakness
Rocuronium + Neostigmine35130379
Rocuronium + Sugammadex30162383
Vecuronium + Neostigmine26145326
Vecuronium + Sugammadex29172404

[back to top]

Time From Start of Administration of Sugammadex or Neostigmine to Recovery of the T4/T1 Ratio to 0.8

Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the amplitudes (heights) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB. A faster time to recovery of the T4/T1 Ratio to 0.8 indicates a faster recovery from NMB. (NCT00451217)
Timeframe: Day 1: From start of sugammadex or neostigmine administration to recovery of T4/T1 ratio to 0.8

InterventionMinutes (Mean)
Rocuronium + Sugammadex1.32
Rocuronium + Neostigmine15.32
Vecuronium + Sugammadex2.12
Vecuronium + Neostigmine15.33

[back to top]

Number of Participants With Clinical Signs of Recovery Assessed by Level of Consciousness, Head Lift and Muscle Weakness, Prior to Discharge From the Recovery Room

Just prior to discharge from the recovery room, neuromuscular recovery was assessed by monitoring every 15 minutes the following clinical signs of recovery: level of consciousness (i.e., awake and oriented, arousable with minimal stimulation, responsive only to tactile stimulation); 5-second head lift test (ability to lift the head for 5 seconds); and general muscle weakness (NCT00451217)
Timeframe: Day 1

,,,
InterventionParticipants (Count of Participants)
Consciousness: Awake and orientedConsciousness: Arousable with minimal stimulationConsciousness: Responsive only to tactile stimuliAble to perform the 5 second head liftHas general muscle weakness
Rocuronium + Neostigmine4800480
Rocuronium + Sugammadex4610470
Vecuronium + Neostigmine4310440
Vecuronium + Sugammadex4800480

[back to top]

Number of Participants Responsive Only to Tactile Stimulation After Anesthesia (Clinical Assessment of Level of Consciousness)

The number of participants responsive only to tactile stimulation was assessed as part of an overall assessment of the clinical level of consciousness by the investigator. The clinical level of consciousness was used as a measure of recovery from NMB at 2 timepoints: prior to transfer to the recovery room after extubation and prior to discharge from the recovery room. Attempts were made to arouse participants every 15 minutes with mild prodding, mild shaking, and asking questions regarding name, location, and day of the week. The assessment ended once the participant was awake and fully orientated, 24 hours, or discharged from the hospital if discharge occurs before 24 hours; whichever occurred first. Participants were given a level of consciousness based on what type of stimulation they responded to. Participants who were not cooperative with the examination were not included in the assessment. (NCT00473694)
Timeframe: Up to 24 hours

,,,
InterventionParticipants (Count of Participants)
Prior to transfer to recovery roomPrior to discharge from recovery room
Rocuronium+Neostigmine30
Rocuronium+Sugammadex20
Vecuronium+Neostigmine70
Vecuronium+Sugammadex70

[back to top]

Number of Participants Awake and Oriented After Anesthesia (Clinical Assessment of Level of Consciousness)

The number of participants who were awake and oriented was assessed as part of an overall assessment of the clinical level of consciousness by the investigator. The clinical level of consciousness was used as a measure of recovery from NMB at 2 timepoints: prior to transfer to the recovery room after extubation and prior to discharge from the recovery room. Attempts were made to arouse participants every 15 minutes with mild prodding, mild shaking, and asking questions regarding name, location, and day of the week. The assessment ended once the participant was awake and fully orientated, 24 hours, or discharged from the hospital if discharge occurs before 24 hours; whichever occurred first. Participants were given a level of consciousness based on what type of stimulation they responded to. Participants who were not cooperative with the examination were not included in the assessment. (NCT00473694)
Timeframe: Up to 24 hours

,,,
InterventionParticipants (Count of Participants)
Prior to transfer to recovery roomPrior to discharge from recovery room
Rocuronium+Neostigmine2032
Rocuronium+Sugammadex2634
Vecuronium+Neostigmine2033
Vecuronium+Sugammadex2739

[back to top]

Number of Participants Aroused With Minimal Stimulation After Anesthesia (Clinical Assessment of Level of Consciousness)

The number of participants aroused with minimal stimulation was assessed as part of an overall assessment of the clinical level of consciousness by the investigator. The clinical level of consciousness was used as a measure of recovery from NMB at 2 timepoints: prior to transfer to the recovery room after extubation and prior to discharge from the recovery room. Attempts were made to arouse participants every 15 minutes with mild prodding, mild shaking, and asking questions regarding name, location, and day of the week. The assessment ended once the participant was awake and fully orientated, 24 hours, or discharged from the hospital if discharge occurs before 24 hours; whichever occurred first. Participants were given a level of consciousness based on what type of stimulation they responded to. Participants who were not cooperative with the examination were not included in the assessment. (NCT00473694)
Timeframe: Up to 24 hours

,,,
InterventionParticipants (Count of Participants)
Prior to transfer to recovery roomPrior to discharge from recovery room
Rocuronium+Neostigmine111
Rocuronium+Sugammadex90
Vecuronium+Neostigmine81
Vecuronium+Sugammadex122

[back to top]

Number of Participants Experiencing General Muscle Weakness

The number of participants experiencing general muscle weakness was assessed by the investigator as a measure of recovery from NMB at 2 timepoints: prior to transfer to the recovery room after extubation and prior to discharge from the recovery room. The assessments were performed every 15 minutes until the absence of general muscle weakness. A standardized examination form was used to determine the presence or absence of muscle weakness in various muscle groups. Participants who were not cooperative with the examination were not included in the assessment. (NCT00473694)
Timeframe: Up to 24 hours

,,,
InterventionParticipants (Count of Participants)
Prior to transfer to recovery roomPrior to discharge from recovery room
Rocuronium+Neostigmine53
Rocuronium+Sugammadex32
Vecuronium+Neostigmine23
Vecuronium+Sugammadex41

[back to top]

Time From Start of Administration of Sugammadex or Neostigmine to Recovery of the T4/T1 Ratio to 0.7 After Neuromuscular Block (NMB) Induced by Rocuronium

Mean time from start of sugammadex or neostigmine administration to recovery of T4/T1 ratio to 0.7 was assessed by applying repetitive train of four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. Nerve stimulation continued until the ratio of the magnitude of the fourth twitch (T4) to first twitch (T1) reached at least 0.7. The greater the T4/T1 ratio represented the greater the recovery from NMB; with a value of 0.0 representing no recovery and 1.0 representing full recovery. Reduced recovery time of the T4/T1 ratio to 0.7 indicated faster recovery from NMB. Mean time was collected in minutes and seconds but converted to and presented in minutes only. The analysis included a procedure for the imputation of missing recovery times. (NCT00473694)
Timeframe: Up to approximately 2 hours after administration of study drug

InterventionMinutes (Mean)
Rocuronium+Sugammadex2.27
Rocuronium+Neostigmine37.68

[back to top]

Time From Start of Administration of Sugammadex or Neostigmine to Recovery of the T4/T1 Ratio to 0.7 After Neuromuscular Block (NMB) Induced by Vecuronium

Mean time from start of sugammadex or neostigmine administration to recovery of T4/T1 ratio to 0.7 was assessed by applying repetitive train of four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. Nerve stimulation continued until the ratio of the magnitude of the fourth twitch (T4) to first twitch (T1) reached at least 0.7. The greater the T4/T1 ratio represented the greater the recovery from NMB; with a value of 0.0 representing no recovery and 1.0 representing full recovery. Reduced recovery time of the T4/T1 ratio to 0.7 indicated faster recovery from NMB. Mean time was collected in minutes and seconds but converted to and presented in minutes only. The analysis included a procedure for the imputation of missing recovery times. (NCT00473694)
Timeframe: Up to approximately 4 hours after administration of study drug

InterventionMinutes (Mean)
Vecuronium+Sugammadex4.10
Vecuronium+Neostigmine56.17

[back to top]

Time From Start of Administration of Sugammadex or Neostigmine to Recovery of the T4/T1 Ratio to 0.8 After Neuromuscular Block (NMB) Induced by Rocuronium

Mean time from start of sugammadex or neostigmine administration to recovery of T4/T1 ratio to 0.8 was assessed by applying repetitive train of four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. Nerve stimulation continued until the ratio of the magnitude of the fourth twitch (T4) to first twitch (T1) reached at least 0.8. The greater the T4/T1 ratio represented the greater the recovery from NMB; with a value of 0.0 representing no recovery and 1.0 representing full recovery. Reduced recovery time of the T4/T1 ratio to 0.8 indicated faster recovery from NMB. Mean time was collected in minutes and seconds but converted to and presented in minutes only. The analysis included a procedure for the imputation of missing recovery times. (NCT00473694)
Timeframe: Up to approximately 3 hours after administration of study drug

InterventionMinutes (Mean)
Rocuronium+Sugammadex2.65
Rocuronium+Neostigmine45.82

[back to top]

Time From Start of Administration of Sugammadex or Neostigmine to Recovery of the T4/T1 Ratio to 0.8 After Neuromuscular Block (NMB) Induced by Vecuronium

Mean time from start of sugammadex or neostigmine administration to recovery of T4/T1 ratio to 0.8 was assessed by applying repetitive train of four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. Nerve stimulation continued until the ratio of the magnitude of the fourth twitch (T4) to first twitch (T1) reached at least 0.8. The greater the T4/T1 ratio represented the greater the recovery from NMB; with a value of 0.0 representing no recovery and 1.0 representing full recovery. Reduced recovery time of the T4/T1 ratio to 0.8 indicated faster recovery from NMB. Mean time was collected in minutes and seconds but converted to and presented in minutes only. The analysis included a procedure for the imputation of missing recovery times. (NCT00473694)
Timeframe: Up to approximately 5 hours after administration of study drug

InterventionMinutes (Mean)
Vecuronium+Sugammadex5.55
Vecuronium+Neostigmine67.42

[back to top]

Time From Start of Administration of Sugammadex or Neostigmine to Recovery of the T4/T1 Ratio to 0.9 After Neuromuscular Block (NMB) Induced by Rocuronium

Mean time from start of sugammadex or neostigmine administration to recovery of T4/T1 ratio to 0.9 was assessed by applying repetitive train of four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. Nerve stimulation continued until the ratio of the magnitude of the fourth twitch (T4) to first twitch (T1) reached at least 0.9. The greater the T4/T1 ratio represented the greater the recovery from NMB; with a value of 0.0 representing no recovery and 1.0 representing full recovery. Reduced recovery time of the T4/T1 ratio to 0.9 indicated faster recovery from NMB. Mean time was collected in minutes and seconds but converted to and presented in minutes only. The analysis included a procedure for the imputation of missing recovery times. (NCT00473694)
Timeframe: Up to approximately 3 hours after administration of study drug

InterventionMinutes (Mean)
Rocuronium+Sugammadex3.28
Rocuronium+Neostigmine55.50

[back to top]

Time From Start of Administration of Sugammadex or Neostigmine to Recovery of the T4/T1 Ratio to 0.9 After Neuromuscular Block (NMB) Induced by Vecuronium

Mean time from start of sugammadex or neostigmine administration to recovery of T4/T1 ratio to 0.9 was assessed by applying repetitive train of four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. Nerve stimulation continued until the ratio of the magnitude of the fourth twitch (T4) to first twitch (T1) reached at least 0.9. The greater the T4/T1 ratio represented the greater the recovery from NMB; with a value of 0.0 representing no recovery and 1.0 representing full recovery. Reduced recovery time of the T4/T1 ratio to 0.9 indicated faster recovery from NMB. Mean time was collected in minutes and seconds but converted to and presented in minutes only. The analysis included a procedure for the imputation of missing recovery times. (NCT00473694)
Timeframe: Up to approximately 6 hours after administration of study drug

InterventionMinutes (Mean)
Vecuronium+Sugammadex8.73
Vecuronium+Neostigmine77.80

[back to top]

Number of Participants Able to Perform a 5-second Head Lift

The number of participants who were able to lift their head for 5 seconds was assessed by the investigator as a measure of recovery from NMB at 2 timepoints: prior to transfer to the recovery room after extubation and prior to discharge from the recovery room. The assessment was performed every 15 minutes until the first successful 5-second head lift was achieved. Participants who were not cooperative with the examination were not included in the assessment. (NCT00473694)
Timeframe: Up to 24 hours

,,,
InterventionParticipants (Count of Participants)
Prior to transfer to recovery roomPrior to discharge from recovery room
Rocuronium+Neostigmine2833
Rocuronium+Sugammadex3334
Vecuronium+Neostigmine2433
Vecuronium+Sugammadex3641

[back to top]

Number of Participants With Evidence of Possible Interaction of Sugammadex With Endogenous Compounds or Exogenous Compounds Other Than Rocuronium Bromide

Evidence of adverse events due to a possible interaction of sugammadex with exogenous compounds or endogenous compounds other than rocuronium was recorded. (NCT00675792)
Timeframe: Up to 7 days after surgery

Interventionparticipants (Number)
Sugammadex0
Neostigmine0

[back to top]

Number of Participants With Post-operative Complications

Post-operative complications include any of the following: procedural pain, nausea, vomiting, incision-site pain, constipation, headache, pyrexia, dizziness and pruritus. (NCT00675792)
Timeframe: Up to 7 days after surgery

Interventionparticipants (Number)
Sugammadex51
Neostigmine49

[back to top]

Residual Neuromuscular Blockade Evidenced by T4/T1 Ratio at the Time of Tracheal Extubation

Neuromuscular function was monitored by applying repetitive Train-Of-Four (TOF) electrical stimulations to the ulnar nerve every 15 seconds, and assessing twitch response at the adductor pollicis muscle with a TOF-Watch® SX. The magnitudes (heights) of the first and fourth twitches (T1 and T4) were used to calculate the T4/T1 ratio, where a higher T4/T1 ratio indicates a greater recovery from neuromuscular blockade, with a value of 1.0 indicating complete recovery. After anesthesia, when neuromuscular function was expected to be fully recovered, tracheal extubation was performed, at which time the T4/T1 ratio was measured, with any missing recovery times imputed. (NCT00675792)
Timeframe: Up to the first 24 hours after tracheal extubation

InterventionT4/T1 Ratio (Mean)
Sugammadex1.02
Neostigmine0.78

[back to top]

Time From Start of Administration of IMP to Recovery of the T4/T1 Ratio to 0.8

Neuromuscular function was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds, and assessing T1 and T4 twitch response at the adductor pollicis muscle with a TOF-Watch® SX. Nerve stimulation was continued until the T4/T1 ratio, which indicates the extent of recovery from neuromuscular blockade, achieved a ratio of 0.8, with imputed data included. (NCT00675792)
Timeframe: Up to 1 hour after treatment

InterventionMinutes (Mean)
Sugammadex1.87
Neostigmine6.18

[back to top]

Time From Start of Administration of Investigational Medicinal Product (IMP) to Recovery of the T4/T1 Ratio to 0.9

Neuromuscular function was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds, and assessing T1 and T4 twitch response at the adductor pollicis muscle with a TOF-Watch® SX. Nerve stimulation was continued until the T4/T1 ratio, which indicates the extent of recovery from neuromuscular blockade, achieved a ratio of 0.9, with imputed data included. (NCT00675792)
Timeframe: Up to 1 hour after treatment

InterventionMinutes (Mean)
Sugammadex2.53
Neostigmine7.95

[back to top]

Time From Start of Administration of IMP to Recovery of the T4/T1 Ratio to 0.7

Neuromuscular function was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds, and assessing T1 and T4 twitch response at the adductor pollicis muscle with a TOF-Watch® SX. Nerve stimulation was continued until the T4/T1 ratio, which indicates the extent of recovery from neuromuscular blockade, achieved a ratio of 0.7, with imputed data included. (NCT00675792)
Timeframe: Up to 1 hour after treatment

InterventionMinutes (Mean)
Sugammadex1.60
Neostigmine4.98

[back to top]

Mean Heart Rate

Heart Rate was measured at screening, before start of rocuronium administration, before start of IMP administration, at 2, 5, 10, 30 minutes post-IMP administration, and at the post-anesthetic visit (the day after surgery). (NCT00724932)
Timeframe: At screening, pre-rocuronium, pre-IMP, at 2, 5, 10, and 30 minutes post-IMP, and at the post-anesthetic visit (the day after surgery)

,
Interventionbeats per minute (Mean)
ScreeningPre-rocuroniumPre-IMP2 minutes post-IMP (N=65, N=65)5 minutes post-IMP10 minutes post-IMP (N=66, N=66)30 minutes post-IMP (N=65, N=66)Post-anesthetic visit (N=66, N=66)
Neostigmine74.663.668.065.357.156.365.171.9
Sugammadex72.963.468.366.064.967.373.172.7

[back to top]

Mean Diastolic Blood Pressure

Diastolic Blood Pressure was measured at screening, before start of rocuronium administration, before start of IMP administration, at 2, 5, 10, 30 minutes post-IMP administration, and at the post-anesthetic visit (the day after surgery). (NCT00724932)
Timeframe: At screening, pre-rocuronium, pre-IMP, at 2, 5, 10, and 30 minutes post-IMP, and at the post-anesthetic visit (the day after surgery)

,
Interventionmm Hg (Mean)
ScreeningPre-rocuroniumPre-IMP2 minutes post-IMP (N=65, N=65)5 minutes post-IMP10 minutes post-IMP (N=66, N=66)30 minutes post-IMP (N=65, N=66)Post-anesthetic visit (N=66, N=66)
Neostigmine82.858.372.572.669.268.773.175.2
Sugammadex80.958.272.873.472.471.874.376.7

[back to top]

Time From Tracheal Extubation to Operating Room Discharge Ready

The time of tracheal extubation was defined as the actual time at which the participant was extubated. The time of Operating Room discharge ready was defined as time at which the participant had T4/T1 ratio of >=0.9 and the participant's wound dressing was in place. (NCT00724932)
Timeframe: From tracheal extubation to Operating Room discharge ready (up to ~1 minute)

Interventionminutes (Mean)
Sugammadex1
Neostigmine0

[back to top]

Time From Tracheal Extubation to Actual Operating Room Discharge

The time of tracheal extubation was defined as the actual time at which the participant was extubated. The time of Operating Room discharge was defined as the actual time at which the participant was discharged from the Operating Room. (NCT00724932)
Timeframe: From tracheal extubation to actual OR discharge (up to ~5 minutes)

Interventionminutes (Mean)
Sugammadex5
Neostigmine5

[back to top]

Time From Start of IMP Administration to Tracheal Extubation

The time of IMP administration was defined as the actual time at which IMP administration was started. The time of tracheal extubation was defined as the actual time at which the participant was extubated. (NCT00724932)
Timeframe: From start of IMP administration to tracheal extubation (up to ~21 minutes)

Interventionminutes (Mean)
Sugammadex14
Neostigmine21

[back to top]

Time From Start of IMP Administration to Operating Room Discharge Ready

The time of IMP administration was defined as the actual time at which IMP administration was started. The time of Operating Room discharge ready was defined as time at which the participant had T4/T1 ratio of >=0.9 and the participant's wound dressing was in place. (NCT00724932)
Timeframe: From start of IMP administration to Operating Room discharge ready (up to ~21 minutes)

Interventionminutes (Mean)
Sugammadex15
Neostigmine21

[back to top]

Time From Start of Administration of the Last Dose of Rocuronium to the Time of Reappearance of T2 in the 50 μg.Kg-1 Neostigmine Group

The time of reappearance of T2 refers to when the second twitch reappears after TOF stimulation. Reappearance of T2 was the target depth of NMB at which neostigmine was to be administered. (NCT00724932)
Timeframe: From last dose of rocuronium to reappearance of T2 (up to ~26 minutes)

Interventionminutes (Geometric Mean)
Neostigmine Only25.6

[back to top]

Time From Start of Administration of the Last Dose of Rocuronium to the Time of 1-2 PTC in the 4.0 mg.Kg-1 Sugammadex Group

The time of 1-2 PTC refers to when 1-2 twitches are generated after tetanic stimulation. Time to 1-2 PTC is the time point of the last single twitch >0 or baseline (in case of noise or direct stimulation) within the sequence of a PTC measurement. 1-2 PTC was the target depth of NMB at which sugammadex was to be administered. (NCT00724932)
Timeframe: From last dose of rocuronium to 1-2 PTC (up to ~9 minutes)

Interventionminutes (Geometric Mean)
Sugammadex Only8.9

[back to top]

Time From Start of Administration of Investigational Medicinal Product (IMP, Sugammadex or Neostigmine) to Recovery of the Fourth Twitch/First Twitch (T4/T1) Ratio to 0.9

Neuromuscular functioning was monitored by applying repetitive Train-Of-Four (TOF) electrical stimulations to the ulnar nerve every 15 seconds & assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the magnitudes (heights) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from neuromuscular blockade (NMB). In this study, twitch responses were recorded until the T4/T1 Ratio reached >= 0.9, the minimum acceptable ratio that indicated recovery from NMB. A faster time to recovery of the T4/T1 Ratio to 0.9 indicates a faster recovery from NMB. (NCT00724932)
Timeframe: From start of IMP administration to recovery of T4/T1 ratio to 0.9 (ranging from ~2 minutes to ~9 minutes)

Interventionminutes (Geometric Mean)
Sugammadex2.4
Neostigmine8.4

[back to top]

Time From Start of Administration of IMP to Recovery of the T4/T1 Ratio to 0.8

Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds & assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the magnitudes (heights) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0). A faster time to recovery of the T4/T1 Ratio to 0.8 indicates a faster recovery from NMB. (NCT00724932)
Timeframe: From start of IMP administration to recovery of T4/T1 Ratio to 0.8 (ranging from ~2 minutes to ~6 minutes)

Interventionminutes (Geometric Mean)
Sugammadex1.9
Neostigmine5.6

[back to top]

Time From Start of Administration of IMP to Recovery of the T4/T1 Ratio to 0.7

Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds & assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the magnitudes (heights) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0). A faster time to recovery of the T4/T1 Ratio to 0.7 indicates a faster recovery from NMB. (NCT00724932)
Timeframe: From start of IMP administration to recovery of T4/T1 Ratio to 0.7 (ranging from ~2 minutes to ~5 minutes)

Interventionminutes (Geometric Mean)
Sugammadex1.6
Neostigmine4.1

[back to top]

Time From PACU Admit to PACU Discharge Ready

The time of PACU admit was defined as the actual time the participant was admitted to the PACU. The time of PACU discharge ready was defined as the time at which the participant had a Modified Aldrete Score >=9. The Modified Aldrete Score was to be assessed at PACU arrival, at 5, 15, 30, 45, 60 minutes after PACU arrival and every 15 minutes thereafter (if applicable) until the participant was ready to be discharged from the PACU. The Modified Aldrete Postoperative Recovery Score (range = 0-10) is calculated based on scores of 0 to 2 each for Activity, Respiration, Circulation, Consciousness and Oxygen Saturation, with a higher score indicating increased postoperative recovery. (NCT00724932)
Timeframe: From PACU admit to PACU discharge ready (up to ~25 minutes)

Interventionminutes (Mean)
Sugammadex20
Neostigmine25

[back to top]

Number of Participants With Reoccurrence of Neuromuscular Blockade Based on the Train-of-Four- (TOF-) Watch® SX Recording (i.e. a Decline in T4/T1 Ratio From >=0.9 to <0.8 in at Least Three Consecutive TOF Values)

Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the magnitudes (heights) of the 1st and 4th twitches, respectively, after TOF stimulation. The T4/T1 Ratio is expressed as a decimal of up to 1.0. A higher ratio indicates greater recovery from NMB. A decline in the T4/T1 ratio from >=0.9 (indicating a recovery from NMB) to <0.8 for at least three consecutive TOF values was considered to be a reoccurrence of NMB. (NCT00724932)
Timeframe: Up to 30 minutes after IMP administration

Interventionparticipants (Number)
Sugammadex0
Neostigmine0

[back to top]

Time From Operating Room Discharge Ready to Post Anesthetic Care Unit (PACU) Discharge Ready

The time of Operating Room discharge ready was defined as time at which the participant had T4/T1 ratio of >=0.9 and the participant's wound dressing was in place. The time of PACU discharge ready was defined as the time at which the participant had a Modified Aldrete Score >=9. The Modified Aldrete Score was to be assessed at PACU arrival, at 5, 15, 30, 45, 60 minutes after PACU arrival and every 15 minutes thereafter (if applicable) until the participant was ready to be discharged from the PACU. The Modified Aldrete Postoperative Recovery Score (range = 0-10) is calculated based on scores of 0 to 2 each for Activity, Respiration, Circulation, Consciousness and Oxygen Saturation, with a higher score indicating increased postoperative recovery. (NCT00724932)
Timeframe: From Operating Room discharge ready to PACU discharge ready (up to ~33 minutes)

Interventionminutes (Mean)
Sugammadex28
Neostigmine33

[back to top]

Time From Operating Room Discharge Ready to Actual PACU Discharge

The time of Operating Room discharge ready was defined as time at which the participant had T4/T1 ratio of >=0.9 and the participant's wound dressing was in place. The time of PACU discharge was defined as the actual time the participant was discharged from the PACU. (NCT00724932)
Timeframe: From Operating Room discharge ready to actual PACU discharge (up to ~4.5 hours)

Interventionminutes (Mean)
Sugammadex268
Neostigmine210

[back to top]

Time From Operating Room Discharge Ready to Actual Operating Room Discharge

The time of Operating Room discharge ready was defined as time at which the participant had T4/T1 ratio of >=0.9 and the participant's wound dressing was in place. The time of Operating Room discharge was defined as the actual time the participant was discharged from the Operating Room. (NCT00724932)
Timeframe: From Operating Room discharge ready to actual Operating Room discharge (up to ~5 minutes)

Interventionminutes (Mean)
Sugammadex4
Neostigmine5

[back to top]

Time From PACU Admit to Actual PACU Discharge

The time of PACU admit was defined as the actual time the participant was admitted to the PACU. The time of PACU discharge was defined as the actual time the participant was discharged from the PACU. (NCT00724932)
Timeframe: From PACU admit to actual PACU discharge (up to ~4.3 hours)

Interventionminutes (Mean)
Sugammadex260
Neostigmine203

[back to top]

Time From Operating Room Admission to Operating Room Discharge Ready

The time of Operating Room admission was defined as the time at which the participant was physically placed into the Operating Room. The time of Operating Room discharge ready was defined as time at which the participant had T4/T1 ratio of ≥0.9 and the participant's wound dressing was in place. (NCT00724932)
Timeframe: From Operating Room admission to Operating Room discharge ready (up to ~3 hours)

Interventionminutes (Mean)
Sugammadex154
Neostigmine165

[back to top]

Time From Operating Room Admission to Actual Operating Room Discharge

The time of Operating Room admission was defined as the time at which the participant was physically placed into the Operating Room. The time of Operating Room discharge was defined as the actual time the participant was discharged from the Operating Room. (NCT00724932)
Timeframe: From Operating Room admission to actual Operating Room discharge (up to ~3 hours)

Interventionminutes (Mean)
Sugammadex158
Neostigmine169

[back to top]

Monitoring of Clinical Signs of Recovery According to Routine Anesthetic Procedures at the Trial Sites

The monitoring of clinical signs of recovery was to be conducted based on the routine anesthetic procedures at each site. (NCT00724932)
Timeframe: Up to PACU discharge (up to ~4.5 hours)

Interventionparticipants (Number)
SugammadexNA
NeostigmineNA

[back to top]

Number of Participants With Clinical Evidence of Reoccurrence of Neuromuscular Blockade or Residual Neuromuscular Blockade (Routine Oxygen Saturation by Pulse Oximetry and Breath Frequency Measurement)

Clinical evidence of reoccurrence of NMB or residual NMB was assessed by oxygen saturation (by pulse oximetry) and breath frequency measurements as per routine practice after anesthesia and neuromuscular monitoring. (NCT00724932)
Timeframe: Up to 24 hours after IMP administration

Interventionparticipants (Number)
Sugammadex1
Neostigmine0

[back to top]

Time From Start of Administration of the Last Dose of Rocuronium to Recovery of the T4/T1 Ratio to 0.5, 0.6, 0.7, 0.8 and 0.9

Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds & assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the magnitudes (heights) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0). A faster time to recovery of the T4/T1 Ratio indicates a faster recovery from NMB. (NCT00724932)
Timeframe: From start of last dose of rocuronium to recovery of T4/T1 Ratio to 0.5, 0.6, 0.7, 0.8 and 0.9 (ranging from ~12 minutes to ~36 minutes)

,
Interventionminutes (Geometric Mean)
Recovery of T4/T1 ratio to 0.5Recovery of T4/T1 ratio to 0.6Recovery of T4/T1 ratio to 0.7Recovery of T4/T1 ratio to 0.8Recovery of T4/T1 ratio to 0.9 (N=65, N=61)
Neostigmine30.030.731.633.235.2
Sugammadex11.711.912.112.513.3

[back to top]

Time From Start of Administration of IMP to Recovery of the T4/T1 Ratio to 0.5 and 0.6

Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds & assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the magnitudes (heights) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0). Faster times to recovery of the T4/T1 Ratios to 0.5 and 0.6 indicate faster recoveries from NMB. (NCT00724932)
Timeframe: From start of IMP administration to recovery of T4/T1 Ratio to 0.5 and 0.6 (ranging from ~1 minute to ~4 minutes)

,
Interventionminutes (Geometric Mean)
Recovery of T4/T1 Ratio to 0.5Recovery of T4/T1 Ratio to 0.6
Neostigmine2.83.4
Sugammadex1.31.5

[back to top]

Time From Start of IMP Administration to Actual Operating Room Discharge

The time of IMP administration was defined as the actual time at which IMP administration was started. The time of Operating Room discharge was defined as the actual time at which the participant was discharged from the Operating Room. (NCT00724932)
Timeframe: From start of IMP administration to actual Operating Room discharge (up to ~26 minutes)

Interventionminutes (Mean)
Sugammadex19
Neostigmine26

[back to top]

Number of Participants Who Experienced Pre-treatment Serious Adverse Events (SAEs) and Post-treatment SAEs

"An SAE is defined as any untoward medical occurrence that at any dose: results in death; is life-threatening; requires in-patient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; or is a congenital anomaly/birth defect.~Participants were monitored for occurrence SAEs for up to 7 days after last dose IMP. Pre-treatment refers to the period from signing of the informed consent up to start of IMP administration. Post-treatment refers to the period from start of IMP administration to 7 days after IMP administration." (NCT00724932)
Timeframe: From signing of informed consent to end of trial (7 days after surgery)

,
Interventionparticipants (Number)
Pre-treatment SAEPost-treatment SAE
Neostigmine06
Sugammadex14

[back to top]

Number of Participants Who Experienced Pre-treatment Non-serious Adverse Events (AEs) and Post-treatment Non-serious AEs

An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body, whether or not considered related to the use of the product. Participants were monitored for occurrence AEs for up to 7 days after last dose IMP. Pre-treatment refers to the period from signing of the informed consent up to start of IMP administration. Post-treatment refers to the period from start of IMP administration to 7 days after IMP administration. (NCT00724932)
Timeframe: From signing of informed consent to end of trial (7 days after surgery)

,
Interventionparticipants (Number)
Pre-treatment non-serious AEPost-treatment non-serious AE
Neostigmine3465
Sugammadex3865

[back to top]

Time From Actual Operating Room Discharge to PACU Discharge Ready

The time of Operating Room discharge was defined as the actual time the participant was discharged from the Operating Room. The time of PACU discharge ready was defined as the time at which the participant had a Modified Aldrete Score >=9. The Modified Aldrete Score was to be assessed at PACU arrival, at 5, 15, 30, 45, 60 minutes after PACU arrival and every 15 minutes thereafter (if applicable) until the participant was ready to be discharged from the PACU. The Modified Aldrete Postoperative Recovery Score (range = 0-10) is calculated based on scores of 0 to 2 each for Activity, Respiration, Circulation, Consciousness and Oxygen Saturation, with a higher score indicating increased postoperative recovery. (NCT00724932)
Timeframe: From actual Operating Room discharge to PACU discharge ready (up to ~30 minutes)

Interventionminutes (Mean)
Sugammadex24
Neostigmine29

[back to top]

Number of Participants With Events Due to a Possible Interaction of Sugammadex With Endogenous Compounds or With Exogenous Compounds Other Than Rocuronium

Any evidence of events due to a possible interaction of sugammadex with endogenous compounds or with exogenous compounds other than rocuronium, was to be recorded. (NCT00724932)
Timeframe: Up to 7 days after IMP administration

Interventionparticipants (Number)
Sugammadex Only0

[back to top] [back to top]

Time From Actual Operating Room Discharge to Actual PACU Discharge

The time of Operating Room discharge was defined as the actual time the participant was discharged from the Operating Room. The time of PACU discharge was defined as the actual time the participant was discharged from the PACU. (NCT00724932)
Timeframe: From actual Operating Room discharge to actual PACU discharge (up to ~4.4 hours)

Interventionminutes (Mean)
Sugammadex264
Neostigmine207

[back to top]

Mean Systolic Blood Pressure

Systolic Blood Pressure was measured at screening, before start of rocuronium administration, before start of IMP administration, at 2, 5, 10, 30 minutes post-IMP administration, and at the post-anesthetic visit (the day after surgery). (NCT00724932)
Timeframe: At screening, pre-rocuronium, pre-IMP, at 2, 5, 10, and 30 minutes post-IMP, and at the post-anesthetic visit (the day after surgery)

,
Interventionmm Hg (Mean)
ScreeningPre-rocuroniumPre-IMP2 minutes post-IMP (N=65, N=65)5 minutes post-IMP10 minutes post-IMP (N=66, N=66)30 minutes post-IMP (N=65, N=66)Post-anesthetic visit (N=66, N=66)
Neostigmine133.9101.6121.3122.5118.0119.3131.7125.4
Sugammadex132.798.2122.1122.5122.6124.0132.9127.3

[back to top]

Number of Female Participants or Partners of Male Participants Who Became Pregnant During Study

Thirty days after administration of IMP, female participants of childbearing potential were asked whether they became pregnant during the trial and male participants were asked whether their partner (if of childbearing potential) became pregnant during the trial. (NCT00724932)
Timeframe: Up to 30 days after IMP administration

Interventionparticipants (Number)
Sugammadex0
Neostigmine0

[back to top]

Polyp Detection

The number of polyps detected during colonoscopic procedures were recorded and compared to each bowel cleansing preparation. (NCT00745095)
Timeframe: Time of Study

InterventionNumber of polyps detected (numerical) (Mean)
SCI MoviPrep® (Without NG)1.3
SCI MoviPrep® (With NG)1.3
SCI PIEE ( Without NG)0.4
SCI PIEE (With NG)0.5
Control MoviPrep® Only0.9
Control PIEE Only0.3

[back to top]

Quality of Bowel Preparation

The quality of bowel preparation was determined by using the Ottawa Scale for bowel Evacuation. The range of this score is from 0 (perfectly clean and dry colon) to 14 ( a colon filled with stool and liquid). The right, mid and rectosigmoid colon were independently rated from 0-4 and fluid quality of entire colon was recorded with an additional score of 0-2. The total Ottawa Score is calculated by the sum of the independent scores of all three sections of the colon plus the fluid content. (NCT00745095)
Timeframe: 1-2 days following intervention

Interventionunits on a scale (Mean)
SCI MoviPrep® (Without NG)3.4
SCI MoviPrep® (With NG)2.5
SCI PIEE (Without NG)3.6
SCI PIEE (With NG)7.4
Control MoviPrep® Only1.8
Control PIEE Only6.9

[back to top]

Shivering

maternal occurrence of shivering--Shivering scored on a 0-no shivering at all up to maximum of 10-shivering uncontrollably (NCT00779467)
Timeframe: until delivery

Interventionunits on a scale (Mean)
Bupivacaine With Neostimgine 8 mcg/ml0.2
Bupivacaine and Neostigmine 4 mcg/ml0.3
Bupivacaine With Neostigmine 2 mcg/ml0.3
BUPIVACAINE WITH FENTANYL 2 MCG/ML0.2

[back to top]

Patient Satisfaction Scores

maternal reported satisfaction scores of labor analgesia on a scale of 1-5, with 1-not satisfied at all up to 5 -completely satisfied with labor analgesia (NCT00779467)
Timeframe: within 24 hours post delivery

Interventionunits on a scale (Median)
Bupivacaine With Neostimgine 8 mcg/ml4.5
Bupivacaine and Neostigmine 4 mcg/ml4.0
Bupivacaine With Neostigmine 2 mcg/ml4.0
BUPIVACAINE WITH FENTANYL 2 MCG/ML4.0

[back to top]

Pruritus

the occurrence of pruritis (itching) throughout the labor analgesia infusion--the presence of itching rated on a scale of 0-no itching at all up to a maximum of 10- severe itching. (NCT00779467)
Timeframe: until delivery

Interventionunits on a scale (Mean)
Bupivacaine With Neostimgine 8 mcg/ml0.05
Bupivacaine and Neostigmine 4 mcg/ml0.03
Bupivacaine With Neostigmine 2 mcg/ml0.03
BUPIVACAINE WITH FENTANYL 2 MCG/ML0.9

[back to top]

Amount of Drug Consumed Per Hour in Each Group(Arm)

Median hourly total bupivacaine consumption. Drug amount consumed per hour of each group (arm) (NCT00779467)
Timeframe: until delivery

Interventionmilliliters per hour (Median)
Bupivacaine With Neostimgine 8 mcg/ml16.2
Bupivacaine and Neostigmine 4 mcg/ml14.6
Bupivacaine With Neostigmine 2 mcg/ml15.3
BUPIVACAINE WITH FENTANYL 2 MCG/ML16

[back to top]

Bromage Score

the incidence of decreased motor block (Bromage score) documented until delivery. Bromage is defined as 0-freely able to move extremities (no motor block) up to 3-unable to move legs or feet (complete motor block) (NCT00779467)
Timeframe: until delivery

Interventionunits on a scale (Mean)
Bupivacaine With Neostimgine 8 mcg/ml0.7
Bupivacaine and Neostigmine 4 mcg/ml1.1
Bupivacaine With Neostigmine 2 mcg/ml1.0
BUPIVACAINE WITH FENTANYL 2 MCG/ML0.9

[back to top]

Cesarean Delivery

percentage of subjects in each group requiring a ceserean delivery (NCT00779467)
Timeframe: occurence

Interventionpercentage of subjects in each group (Number)
Bupivacaine With Neostimgine 8 mcg/ml21
Bupivacaine and Neostigmine 4 mcg/ml15
Bupivacaine With Neostigmine 2 mcg/ml24
BUPIVACAINE WITH FENTANYL 2 MCG/ML14

[back to top]

Nausea

average maximum nausea score in each group--maternal nausea scored on a 0-no nausea at all up to maximum of 10-worst nausea imaginable (NCT00779467)
Timeframe: until delivery

Interventionunits on a scale (Mean)
Bupivacaine With Neostimgine 8 mcg/ml1.3
Bupivacaine and Neostigmine 4 mcg/ml1.8
Bupivacaine With Neostigmine 2 mcg/ml1.8
BUPIVACAINE WITH FENTANYL 2 MCG/ML1.2

[back to top]

Sedation

average maternal sedation score measured on a 0-not sleepy at all up to a maximum of 10-extremely sleepy (NCT00779467)
Timeframe: until delivery

Interventionunits on a scale (Mean)
Bupivacaine With Neostimgine 8 mcg/ml3.3
Bupivacaine and Neostigmine 4 mcg/ml3.4
Bupivacaine With Neostigmine 2 mcg/ml3.3
BUPIVACAINE WITH FENTANYL 2 MCG/ML4.1

[back to top]

Time From Start of Administration of IMP to Recovery of the T4/T1 Ratio to 0.7 and 0.8.

Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. The greater the T4/T1 ratio the greater the recovery from neuromuscular blockade. (NCT00825812)
Timeframe: start of administration of sugammadex/neostigmine to recovery from neuromuscular blockade

,,,
Interventionminutes (Geometric Mean)
Recovery of T4/T1 ratio to 0.7Recovery of T4/T1 ratio to 0.8
Neostigmine in Caucasian Subjects3.44.6
Neostigmine in Chinese Subjects4.46.0
Sugammadex in Caucasian Subjects1.01.2
Sugammadex in Chinese Subjects1.11.3

[back to top]

Time From Start of Administration of Investigational Medicinal Product (IMP) to Recovery of the T4/T1 Ratio to 0.9.

"Neuromuscular functioning was monitored by applying repetitive train of four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. Nerve stimulation was to continue until the ratio of the magnitude of the fourth twitch (T4) to first twitch (T1) reached >= 0.9. The greater the T4/T1 ratio the greater the recovery from neuromuscular blockade, with a value of 1.0 representing full recovery.~The primary analysis was the comparison between sugammadex & neostigmine among Chinese subjects; other comparisons were secondary." (NCT00825812)
Timeframe: start of administration of sugammadex/neostigmine to recovery from neuromuscular blockade

Interventionminutes (Geometric Mean)
Sugammadex in Caucasian Subjects1.4
Neostigmine in Caucasian Subjects6.7
Sugammadex in Chinese Subjects1.6
Neostigmine in Chinese Subjects9.1

[back to top]

Mesure of the Train-of-four (TOF)

train-of-four monitoring (also known as neuromuscular monitoring), is a technique used during recovery from the application of general anesthesia to objectively determine how well a patient's muscles are able to function, by recording muscle response after nerves electrical stimulation. (NCT00847938)
Timeframe: from neostigmine injection to TOF ratio = 0.9 and 1.0, evaluated every minute up to 1 hour

,,,
Interventionminute (Median)
recovery time to TOF ratio of 0.9recovery time to TOF ratio of 1.0
Neostigmine 10 µg/kg11.517
Neostigmine 20 µg/kg4.57.8
Neostigmine 40 µg/kg3.85.5
Placebo1926

[back to top]

Time From Start of Study Drug Administration to Recovery of the T4/T1 Ratio to 0.9

Neuromuscular functioning was monitored by applying repetitive Train-Of-Four (TOF) electrical stimulations to the ulnar nerve every 15 seconds & assessing twitch response at the adductor pollicis muscle. T1 & T4 refer to the magnitudes (height) of the 1st & 4th twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from neuromuscular blockade. In this study, twitch responses were recorded until the T4/T1 Ratio reached >= 0.9, the minimum acceptable ratio that indicated complete recovery. (NCT01050543)
Timeframe: From Start of Study Drug Administration to Recovery of the T4/T1 Ratio to 0.9 (estimated from 2 minutes up to ~15 minutes)

Interventionminutes (Geometric Mean)
Sugammadex1.77
Neostigmine14.80

[back to top]

Nausea and Vomiting

Patients were asked to rate their experience of nausea and vomiting on a 0-10 verbal analog scale, with 0 being absence and 10 being the worst imaginable (NCT01199237)
Timeframe: 60 minutes after T1

,
Interventionunits on a scale (Mean)
NauseaVomiting
Desflurane1.3330.026
Sevoflurane0.2630

[back to top]

Nausea and Vomiting

Patients were asked to rate their experience of nausea and vomiting on a 0-10 verbal analog scale, with 0 being absence and 10 being the worst imaginable (NCT01199237)
Timeframe: 30 minutes after T1

,
Interventionunits on a scale (Mean)
NauseaVomiting
Desflurane1.3590
Sevoflurane0.3850

[back to top]

Time From Potent Inhaled Anesthetic Discontinuation to First Response to Command (T1)

"At the conclusion of surgery, after the patient's potent inhaled anesthetic was discontinued, the commands open your eyes and squeeze my hand were given at 30-second intervals. The time at which patient first appropriately response to both commands was noted as T1." (NCT01199237)
Timeframe: Up to 1 hour post-operative

Interventionseconds (Mean)
Sevoflurane623
Desflurane343

[back to top]

Time From Anesthetic Discontinuation to First Ability to Swallow

At 2 minutes after first response to command (T1), the patient was asked to swallow 20 mL of water from a paper cup, and an observer blinded to anesthetic assignment assessed the ability to swallow based on transit of water to the posterior pharynx (absence of pooling or drooling) and absence of cough or gag (indicating misdirection of the water bolus into the laryngeal inlet). This test was repeated at 6, 14, 22, 30 and 60 minutes after the time of first response to command. (NCT01199237)
Timeframe: up to 60 minutes after T1

InterventionSeconds (Mean)
Sevoflurane1275
Desflurane718

[back to top]

Recovery of Ability to Swallow After Neostigmine/Glycopyrrolate Antagonism of Rocuronium Paralysis.

The patient is judged by the primary anesthetist to be awake at time T1. At 2 minutes after T1, the patient was asked to swallow 20mL of water from a paper cup, and a blinded observer judged the ability to swallow based on transit of water to the posterior pharynx (absence of pooling or drooling) and absence of cough or gag. (NCT01199237)
Timeframe: At 2 minutes after response to command (T1).

,
Interventionparticipants (Number)
able to swallow at T1+2 minutesunable to swallow at T1+2 minutes
Desflurane256
Sevoflurane1610

[back to top]

Number of Participants Requiring Any Postoperative Transfusion

The number of participants who received a transfusion unit (e.g., whole blood, packed RBCs, cell saver RBCs, fresh frozen plasma, platelets) that started after study drug administration and within 120 hours after study drug administration (or within 48 hours after any previous [i.e., predose] transfusion for participants who had received a previous transfusion) was determined. (NCT01422304)
Timeframe: From end of study drug administration through approximately 120 hours after study drug administration

Interventionparticipants (Number)
Sugammadex221
Usual Care227

[back to top]

Number of Participants With One or More Adjudicated Events of Anaphylaxis With Onset Within 14 Days After Study Drug Administration

This Measure is identified in study protocol as an Other Secondary Outcome Measure. Anaphylaxis is a serious allergic reaction that is rapid in onset and may cause death. Adverse events suggestive of hypersensitivity which met defined criteria (e.g., serious event) and/or suspected events of anaphylaxis were evaluated by a blinded external Adjudication Committee to determine whether such events met either of the following two criteria for anaphylaxis (Sampson et al. J Allergy Clin Immunol 2006;117:391-7) - 1. Acute onset of an illness with involvement of the skin, mucosal tissue or both, and at least one of the following: a) respiratory compromise, b) reduced blood pressure (BP) or associated symptoms of end-organ dysfunction. 2. Two or more of the following that occur rapidly after exposure to a likely allergen for that participant: a) involvement of the skin-mucosal tissue, b) respiratory compromise, c) reduced BP or associated symptoms, d) persistent gastrointestinal symptoms. (NCT01422304)
Timeframe: Up to 14 days post study drug administration

Interventionparticipants (Number)
Sugammadex0
Usual Care0

[back to top]

Number of Participants With One or More Adjudicated Events of Bleeding (Major or Non-major) With Onset Within 14 Days After Study Drug Administration

"This Measure is identified in study protocol as an Other Secondary Outcome Measure. Post-treatment events of bleeding were evaluated by a medically-qualified, blinded member of the surgical team (Blinded Safety Assessor), in consultation with the surgeon, to determine if an event was a suspected, unanticipated adverse event of bleeding (SUAEB). A SUAEB is an event of bleeding outside the usual boundaries of expectations for a participant considering the type of procedure as well as participant's specific surgical experience and underlying risk of bleeding. In addition, blinded review of clinical and laboratory databases was performed to identify any event potentially consistent with a SUAEB; these were reviewed by the Blinded Safety Assessor, who determined if any was a SUAEB. All SUAEBs were evaluated by a blinded external Adjudication Committee, which classified each as either: 1) a major bleeding event, 2) a non-major bleeding event, or 3) not an unanticipated event of bleeding." (NCT01422304)
Timeframe: Up to 14 days post study drug administration

Interventionparticipants (Number)
Sugammadex24
Usual Care27

[back to top]

Number of Participants With One or More Adjudicated Events of Bleeding (Major or Non-major) With Onset Within 24 Hours After Study Drug Administration

"Post-treatment events of bleeding were evaluated by a medically-qualified, blinded member of the surgical team (Blinded Safety Assessor), in consultation with the surgeon, to determine if an event was a suspected, unanticipated adverse event of bleeding (SUAEB). A SUAEB is an event of bleeding outside the usual boundaries of expectations for a participant (e.g., in amount of blood lost, prolonged duration of bleeding, or other factors) considering the type of procedure as well as participant's specific surgical experience and underlying risk of bleeding. In addition, blinded review of clinical and laboratory databases was performed to identify any event potentially consistent with a SUAEB; these were reviewed by the Blinded Safety Assessor, who determined if any was a SUAEB. All SUAEBs were evaluated by a blinded external Adjudication Committee, which classified each as either: 1) a major bleeding event, 2) a non-major bleeding event, or 3) not an unanticipated event of bleeding." (NCT01422304)
Timeframe: Up to 24 hours post study drug administration

Interventionparticipants (Number)
Sugammadex17
Usual Care24

[back to top]

Number of Participants With One or More Adjudicated Major Events of Bleeding With Onset Within 14 Days After Study Drug Administration

This Measure is identified in study protocol as an Other Secondary Outcome Measure. All SUAEB were evaluated by a blinded external Adjudication Committee. MBE = one or more of the following: 1) Fatal bleeding; 2) Bleeding that is symptomatic and occurs in critical area/organ, in a non-operated joint, or is intramuscular with compartment syndrome; 3) Extrasurgical site bleeding causing a fall in Hgb level of 20 g/L (1.24 mmol/L) or more, or leading to transfusion of two or more units of whole blood or RBCs, occurring within 24 hours of the bleeding; 4) Surgical site bleeding requiring second intervention, or bleeding at operated joint that interferes with rehabilitation; or 5) Surgical site bleeding that is unexpected/prolonged and/or causes hemodynamic instability, with fall in Hgb level of at least 20 g/L (1.24 mmol/L) or transfusion of at least two units of whole blood or RBCs, occurring within 24 hours of the bleeding. (NCT01422304)
Timeframe: Up to 14 days post study drug administration

Interventionparticipants (Number)
Sugammadex18
Usual Care23

[back to top]

Number of Participants With One or More Adjudicated Major Events of Bleeding With Onset Within 24 Hours After Study Drug Administration

This Measure is identified in study protocol as an Other Secondary Outcome Measure. All SUAEB were evaluated by a blinded external Adjudication Committee. Major bleeding event (MBE) = one or more of the following: 1) Fatal bleeding; 2) Bleeding that is symptomatic and occurs in critical area/organ, in a non-operated joint, or is intramuscular with compartment syndrome; 3) Extrasurgical site bleeding causing a fall in hemoglobin (Hgb) level of 20 g/L (1.24 mmol/L) or more, or leading to transfusion of two or more units of whole blood or red blood cells (RBCs), occurring within 24 hours of the bleeding; 4) Surgical site bleeding requiring second intervention, or bleeding at operated joint that interferes with rehabilitation; or 5) Surgical site bleeding that is unexpected/prolonged and/or causes hemodynamic instability, with fall in Hgb level of at least 20 g/L (1.24 mmol/L) or transfusion of at least two units of whole blood or RBCs, occurring within 24 hours of the bleeding. (NCT01422304)
Timeframe: Up to 24 hours post study drug administration

Interventionparticipants (Number)
Sugammadex12
Usual Care20

[back to top]

Number of Participants With One or More Adjudicated Venous Thromboembolic (VTE) Events With Onset Within 14 Days After Study Drug Administration

This Measure is identified in study protocol as an Other Secondary Outcome Measure. Suspected symptomatic VTE events were evaluated by a blinded external Adjudication Committee. The confirmation of a VTE event was based on determination of a clinically meaningful venous thrombosis (e.g., pulmonary embolism or deep vein thrombosis). (NCT01422304)
Timeframe: Up to 14 days post study drug administration

Interventionparticipants (Number)
Sugammadex5
Usual Care3

[back to top]

Number of Participants With One or More Postoperative Anemia Adverse Events With Onset Within 72 Hours After Study Drug Administration

This measure is the incidence of postoperative anaemia with an onset within 72 hours after study drug administration. A participant is included in the count for this measure if an adverse event with any of the following event terms occurred in the participant with onset within the defined time frame: postoperative anaemia, anaemia, haemorrhagic anaemia, haemoglobin decreased or haemoglobin S decreased. (NCT01422304)
Timeframe: Up to 72 hours post study drug administration

Interventionparticipants (Number)
Sugammadex124
Usual Care132

[back to top]

Postoperative Changes in Hgb Concentrations Using the Bleeding Index

The Bleeding Index was used to describe postoperative changes in Hgb concentrations at Visit 3. Bleeding Index = Hgb level at Visit 3 - Hgb level at baseline, adjusted for the amount of RBCs transfused. Missing baseline Hgb values were imputed using the overall mean Hgb value at baseline. (NCT01422304)
Timeframe: Baseline and Visit 3 (24-48 hours post study drug administration)

Interventiong/L (Mean)
Sugammadex-15.7
Usual Care-17.4

[back to top]

Postoperative Drainage Volume Within 24 Hours After Study Drug Administration

The total volume of postoperative drainage from the surgical site over the 24 hours after study drug administration was recorded. (NCT01422304)
Timeframe: Up to 24 hours post study drug administration

InterventionmL (Mean)
Sugammadex464
Usual Care476

[back to top]

Total Transfusion Volume in Participants Who Required Postoperative Transfusion

"Among participants who received a transfusion unit (e.g., whole blood, packed RBCs, cell saver RBCs, fresh frozen plasma, platelets) that started after study drug administration and within 120 hours after study drug administration (or within 48 hours after any previous [i.e., predose] transfusion for participants who had received a previous transfusion), the total volume of blood transfused post study drug was calculated. The volume of blood transfused post study drug (using linear interpolation when transfusions were ongoing at the time of study drug administration) was converted to grams of Hgb transfused, using RBC concentration information received from the investigators. The sum of Hgb transfused was standardized to normal volume Hgb in homologous whole blood, using 20 g/dL Hgb for calculation of the standardized volume." (NCT01422304)
Timeframe: From end of study drug administration through approximately 120 hours after study drug administration

InterventionmL (Geometric Mean)
Sugammadex335
Usual Care345

[back to top]

Percent Change From Baseline in Activated Partial Thromboplastin Time (aPTT) at 10 and 60 Minutes Post Study Drug Administration

Change from baseline in aPTT is identified in study protocol as the Key Secondary Outcome Measure. Blood samples for determination of aPTT values were obtained at baseline and at 10 and 60 minutes after study drug administration. aPTT is a performance indicator measuring the efficacy of the intrinsic and common blood coagulation (blood clotting) pathways. Higher values of aPTT indicate a reduction in the clotting tendency of blood. (NCT01422304)
Timeframe: Baseline, 10 and 60 minutes post study drug administration

,
Interventionpercent change (Mean)
10 minutes (Sugammadex n=525, Usual Care n=507)60 minutes (Sugammadex n=523, Usual Care n=505)
Sugammadex6.00.4
Usual Care-0.1-1.2

[back to top]

Percent Change From Baseline in Prothrombin Time (International Normalized Ratio) (PT[INR]) at 10 and 60 Minutes Post Study Drug Administration

Change from baseline in PT(INR) is identified in study protocol as an Other Secondary Outcome Measure. Blood samples for determination of PT(INR) values were obtained at baseline and at 10 and 60 minutes after study drug administration. PT(INR) is a performance indicator measuring the efficacy of the extrinsic and common blood coagulation (blood clotting) pathways. The INR is the ratio of a participant's prothrombin time to a normal (control) sample, raised to the power of the International Sensitivity Index (ISI) value for the analytical system used (INR = [PT-Test/PT-Normal]^ISI). Higher values of PT(INR) indicate a reduction in the clotting tendency of blood. (NCT01422304)
Timeframe: Baseline, 10 and 60 minutes post study drug administration

,
Interventionpercent change (Mean)
10 minutes (Sugammadex n=526, Usual Care n=507)60 minutes (Sugammadex n=524, Usual Care n=505)
Sugammadex8.08.9
Usual Care2.53.4

[back to top]

Incidence of Residual Neuromuscular Blockade (NMB) as Defined by a Train-of-Four (TOF) Ratio <0.9 at Post Anesthesia Care Unit (PACU) Entry

Neuromuscular functioning was monitored by applying four TOF electrical stimulations to the ulnar nerve and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the magnitudes (height) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB, with a higher ratio indicating greater recovery from NMB. A T4/T1 Ratio of <0.9 is indicative of residual NMB. (NCT01479764)
Timeframe: At PACU entry on Day 1

Interventionparticipants (Number)
Sugammadex0
Neostigmine/Glycopyrrolate33

[back to top]

Time From Start of Study Drug Administration to Operating Room Discharge-ready

The time of operating room discharge readiness was determined by the surgical team based on clinical evaluations. (NCT01479764)
Timeframe: Day 1

Interventionminutes (Least Squares Mean)
Sugammadex15.02
Neostigmine/Glycopyrrolate18.05

[back to top]

Number of Intra-abdominal Pressure Rises > 18cmH2O

The number of intra-abdominal pressure rises > 18cmH2O detected by the intra-abdominal CO2 insufflator. (NCT01748643)
Timeframe: Participants will be followed for the duration of the laparoscopic gastric bypass surgery, an expected average of 1.5h

Interventionnumber of intra-abdominal pressure rises (Mean)
Deep Neuromuscular Blockade, Reversal With Sugammadex0.2
Normal Neuromuscular Blockade, Reversal With Neostigmine0.3

[back to top]

Peak Expiratory Flow

Peak expiratory flow is measured with the Vitalograph® electronic portable peak flow meter. A mean of 3 measurements in the upright posture in bed before and after surgery will be used. (NCT01748643)
Timeframe: Measured the day before surgery and 30min after completion of surgery (when the modified observer's assessment of alertness/sedation scale is 5 (Patient responds readily to name spoken in normal tone))

Interventionpercent change from baseline (Mean)
Deep Neuromuscular Blockade, Reversal With Sugammadex51.3
Normal Neuromuscular Blockade, Reversal With Neostigmine51.5

[back to top]

Subjective Evaluation of the View on the Operating Field by the Surgeon

"At the end of surgery, the view on the operating field will be graded by the surgeon using a 5-point rating scale:~Extremely poor~Poor~Acceptable~Good~Optimal" (NCT01748643)
Timeframe: Participants will be followed for the duration of the laparoscopic gastric bypass surgery, an expected average of 1.5h

Interventionunits on a scale (Mean)
Deep Neuromuscular Blockade, Reversal With Sugammadex4.2
Normal Neuromuscular Blockade, Reversal With Neostigmine3.9

[back to top]

Duration of Surgery

Measured from the time of first skin incision to completion of skin closure. (NCT01748643)
Timeframe: Participants will be followed for the duration of the laparoscopic gastric bypass surgery, an expected average of 1.5h

Interventionminutes (Mean)
Deep Neuromuscular Blockade, Reversal With Sugammadex61.3
Normal Neuromuscular Blockade, Reversal With Neostigmine70.6

[back to top]

Forced Expiratory Volume in 1 Second

Forced expiratory volume in 1 second is measured with the Vitalograph® electronic portable peak flow meter. A mean of 3 measurements in the upright posture in bed before and after surgery will be used. (NCT01748643)
Timeframe: Measured the day before surgery and 30min after completion of surgery (when the modified observer's assessment of alertness/sedation scale is 5 (Patient responds readily to name spoken in normal tone))

Interventionpercent change from baseline (Mean)
Deep Neuromuscular Blockade, Reversal With Sugammadex45.2
Normal Neuromuscular Blockade, Reversal With Neostigmine48.8

[back to top]

Forced Vital Capacity

Forced vital capacity is measured with the Vitalograph® electronic portable peak flow meter. A mean of 3 measurements in the upright posture in bed before and after surgery will be used. (NCT01748643)
Timeframe: Measured the day before surgery and 30min after completion of surgery (when the modified observer's assessment of alertness/sedation scale is 5 (Patient responds readily to name spoken in normal tone))

Interventionpercent change from baseline (Mean)
Deep Neuromuscular Blockade, Reversal With Sugammadex51.9
Normal Neuromuscular Blockade, Reversal With Neostigmine49.0

[back to top]

Electric Activity of the Diaphragm (Microvolts)

(NCT01962298)
Timeframe: From the start of spontaneous breathing till extubation, limited to maximum ten minutes after the onset of spontaneous breathing

Interventionmicrovolt (Median)
Single Rocuronium Dose - Placebo3.7
Single Rocuronium Dose - Sugammadex4.5
Repeated Rocuronium Dose - Neostigmine3.2
Repeated Rocuronium Dose - Sugammadex2.9
Continuous Rocuronium Dose4.4

[back to top]

Electric Activity of the Intercostal Muscles

(NCT01962298)
Timeframe: From the start of spontaneous breathing till extubation, limited to maximum ten minutes after the onset of spontaneous breathing

Interventionmicrovolt (Median)
Single Rocuronium Dose - Placebo2.4
Single Rocuronium Dose - Sugammadex2.2
Repeated Rocuronium Dose - Neostigmine1.5
Repeated Rocuronium Dose - Sugammadex2.2
Continuous Rocuronium Dose1.8

[back to top]

Overall Surgical Condition

overall surgical conditions using the 5-point rating scale as previously described: Grade 5 (optimal), optimal surgical conditions; grade 4 (good), nonoptimal conditions, but an intervention is not required; grade 3 (acceptable), wide surgical view, but an intervention can improve surgical conditions, grade 2 (poor), inadequate conditions, there is a visible view, but an intervention is necessary to ensure acceptable surgical conditions; grade 1 (extremely poor), inability to perform surgery; therefore, intervention is necessary. (NCT02109133)
Timeframe: At the end of the Steep trendelenburg position, an average of 1 hour

Interventionunits on a scale (Median)
Moderate Neuromuscular Blockade4.0
Deep Neuromuscular Blockade3.0

[back to top]

Post-operative Nausea

(NCT02109133)
Timeframe: During 24hours after operation

Interventionevents (Number)
Moderate Neuromuscular Blockade (Moderate NMB Group)4
Deep Neuromuscular Blockade (Deep NMB Group)1

[back to top]

Incidence of Residual Neuromuscular Blockade

(NCT02109133)
Timeframe: During 24hours after operation

Interventionparticipants (Number)
Moderate Neuromuscular Blockade (Moderate NMB Group)0
Deep Neuromuscular Blockade (Deep NMB Group)0

[back to top]

Maximum Intraocular Pressure During RALRP Under Deep Neuromuscular Blockade

maximum intraocular pressure during RALRP under deep neuromuscular blockade after being positioned in the steep Trendelenburg position with CO2 pneumoperitoneum under deep neuromuscular blockade (NCT02109133)
Timeframe: Maximum intraocular pressure was measured at 60 minutes after CO2 pneumoperitoneum in the ST position

InterventionmmHg (Mean)
Moderate Neuromuscular Blockade (Moderate NMB Group)23.3
Deep Neuromuscular Blockade (Deep NMB Group)19.8

[back to top]

Mean Lowest Saturation

Mean saturation is the mean value of the beat-to-beat Hb-oxygen saturation measured by finger pulse oximeter as measured in the first 45 min in the recovery room following surgery (NCT02243943)
Timeframe: 45 minutes post surgery

Interventionpercentage of oxygen saturation (Mean)
Sugammadex96.8
Neostigmine93.3

[back to top]

Pain

using the 1-10 numeric rating scale (NCT02243943)
Timeframe: 45 minutes post surgery

InterventionNumeric rating scale. 1(low)-10(maximum) (Mean)
Sugammadex3.0
Neostigmine3.2

[back to top]

Sedation

using the Leiden observer alertness score (1 alert - 5 sedated) (NCT02243943)
Timeframe: 45 minutes post surgery

Interventionsedation scale (1 alert - 5 sedated) (Mean)
Sugammadex1.4
Neostigmine1.4

[back to top]

Time to Extubation

We expected the emergence time is shorter in R-S group than S-C-N group. So we measure the time from the end of surgery to recovery of the TOF 0.9, and the time from the end of surgery to extubation (NCT02329964)
Timeframe: from the end of surgery to extubate a tracheal tube

Interventionseconds (Median)
R-S Group430
S-C-N Group380

[back to top]

Time to Eye Opening

We expected the emergence time is shorter in R-S group than S-C-N group. So we measure the time from the end of surgery to opening of the eyes to verbal commands. (NCT02329964)
Timeframe: from end of surgery to opening of the eyes to verbal commands

Interventionseconds (Median)
R-S Group340
S-C-N Group300

[back to top]

Time to First Spontaneous Breath

time from end of surgery to first spontaneous breaths (NCT02329964)
Timeframe: from end of surgery to first spontaneous breaths

Interventionseconds (Median)
R-S Group263
S-C-N Group240

[back to top]

Recovery of T1 to 90%

we measure the time from the end of surgery to recovery of the TOF 0.9. The end of surgery is defined as the time when the direct laryngoscope, aided by an operation microscope, is removed. (NCT02329964)
Timeframe: from the end of surgery(when the surgeon removes the suspension laryngoscope ) to time when the TOF ratio is 0.9, up to 30 minutes

Interventionseconds (Median)
R-S Group377
S-C-N Group240

[back to top]

Addition of Neuromuscular Blocking Agents

"Repeated small boluses or drip of Succinylcholine, or small boluses of nondepolarizing muscle relaxants with intermediate duration are usually followed.~In this protocol, cisatracurium was injected after intubation to maintain neuromuscular blockade during surgery.~We measure the requirement of additive dose of neuromuscular blocker to ensure that neuromuscular blockade remains below T2 during surgery" (NCT02329964)
Timeframe: during surgery

Interventionparticipants (Number)
R-S Group0
S-C-N Group20

[back to top]

Anesthesia Time

time from propofol injection to extubation (NCT02329964)
Timeframe: from the anesthesia start to end

Interventionminutes (Mean)
R-S Group28.4
S-C-N Group35.2

[back to top]

Length of Stay in te Operating Room

LMS surgery has short operation time and ambulatory setting. So the length of stay in the operating room will have significant. We expected the lengh of stay in the operating room is more shorter in R-S group than S-C-N group. (NCT02329964)
Timeframe: time from in to out of the operating room

Interventionminutes (Mean)
R-S Group31.0
S-C-N Group38.6

[back to top]

Recovery of T1 to 10%

we measure the time from the end of surgery to recovery of the TOF 0.1. The end of surgery is defined as the time when the direct laryngoscope, aided by an operation microscope, is removed. (NCT02329964)
Timeframe: from the end of surgery to time when the TOF ratio is 0.1, up to 30 minutes

Interventionseconds (Median)
R-S Group271
S-C-N Group190

[back to top]

Surgical Rating Score

"describe by surgeon under his subjective opinion.~1 - extremely poor conditions 2- poor conditions 3- acceptable conditions 4- good conditions 5- optimal conditions" (NCT02329964)
Timeframe: during surgery

Interventionscore (Median)
R-S Group5.0
S-C-N Group5.0

[back to top]

Recovery Time From Neuromuscular Blockade

We measured recovery time ffrom the injection of neostigmine or sugammadex to TOF ratio 0.9 (NCT02330172)
Timeframe: from the injection of neostigmine or sugammadex up to 30 minutes

Interventionminute (Mean)
Rocuronium 0.45 - Neostigmine9.9
Rocuronium 0.9 - Sugammadex2.1

[back to top]

Laryngoscopic Score

"Definitions for evaluation of Laryngoscopycondition.~: Easy = jaw relaxed, no resistance to blade insertion, fair = jaw not fully relaxed, slight resistance to blade insertion, difficult = poor jaw relaxation, active resistance of the patient to laryngoscopy.~Variables Excellent Good Poor" (NCT02330172)
Timeframe: At the beginning of surgery, the surgeon rated the laryngoscopy condition

,
InterventionParticipants (Count of Participants)
DifficultFairEasy
Rocuronium 0.45 - Neostigmine1119
Rocuronium 0.9 - Sugammadex0019

[back to top]

Death of 90 Days

Death during from randomization to 90 days after onset. (NCT02543658)
Timeframe: From randomization to 90 days after onset.

InterventionParticipants (Count of Participants)
Neostigmine10
Conservative Treatment11

[back to top]

Medical Expenses

Medical expenses within 6 months after randomisation (NCT02543658)
Timeframe: From randomisation to 6 months

Interventionthousand(RMB) (Median)
Neostigmine95.3
Conservative Treatment102.3

[back to top]

New-onset Abdominal Compartment Syndrom

Abdominal compartment syndrome is defined as a sustained IAP>20 mmHg (with or without an APP<60 mmHg) that is associated with new organ dysfunction/failure (NCT02543658)
Timeframe: From randomization to discharge or death, assessed up to 4 weeks

InterventionParticipants (Count of Participants)
Neostigmine2
Conservative Treatment4

[back to top]

Number of Participants With Adverse Effects on the Cardiovascular System

Due to that neostigmine has an inhibitory effect on the cardiovascular system, new-onset cardiovascular failure after grouping is considered as a possible adverse event related to neostigmine.Cardiovascular failure was defined as circulatory systolic blood pressure <90 mm Hg, despite adequate fluid resuscitation, or need for inotropic catecholamine support (NCT02543658)
Timeframe: From randomization to 7 days

InterventionParticipants (Count of Participants)
Neostigmine8
Conservative Treatment4

[back to top]

Number of Participants With Deterioration of IAH

IAP rebound ≥ 5mmHg or increase ≥ 20mmHg within 1-7 days after grouping (NCT02543658)
Timeframe: From randomization to 7 days

InterventionParticipants (Count of Participants)
Neostigmine4
Conservative Treatment8

[back to top]

Timing of Enteral Nutrition

From date of randomization to enteral nutrition, assessed up to 30 days (NCT02543658)
Timeframe: Start time of enteral nutrition after randomization, assessed up to 30 days

Interventiondays (Median)
Neostigmine3
Conservative Treatment4

[back to top]

Percent Change of IAP After Treatment

Monitor the intra-abdominal pressure within 1 to 7 days after randomization, and calculate the percent change compared with that before randomization (NCT02543658)
Timeframe: From randomization to 7 days after treatment,Measured IAP every 6 hours

,
Interventionpercent change of IAP (Median)
percent change of IAP at 24 hourspercent change of IAP at 7 days
Conservative Treatment-5.4-20.0
Neostigmine-18.7-27.2

[back to top]

The Change of Stool Volume at 1-7 Days After Randomization

After randomization, the change of stool volume (ML) was calculated every 24 hours.For example, the amount of stool volume decreased or increased in 24 hours after grouping compared to before grouping. (NCT02543658)
Timeframe: From randomization to 7 days

,
Interventionml/day (Median)
The change of stool volume at 24 hoursThe change of stool volume at 7th day
Conservative Treatment60370
Neostigmine8701025

[back to top]

New-onset Organ Failure

Incidence of organ failure from randomization to discharge or death, assessed up to 3 months (NCT02543658)
Timeframe: From randomization to discharge or death, assessed up to 3 months

InterventionParticipants (Count of Participants)
Neostigmine12
Conservative Treatment16

[back to top]

Days in Hospital

Days in hospital within 6 months after randomisation (NCT02543658)
Timeframe: From randomisation to 6 months

Interventiondays (Median)
Neostigmine20
Conservative Treatment19

[back to top]

Days in ICU

Days in ICU within 6 months after randomisation (NCT02543658)
Timeframe: From randomisation to 6 months

Interventiondays (Median)
Neostigmine12
Conservative Treatment12

[back to top]

Breathing Increase Due to a Reduction in Inspired Oxygen Saturation (Hypoxic Ventilatory Response)

The change in breathing response to a decrease in inspired oxygen concentration, which equals the isocapnic ventilatory response to hypoxia. (NCT02845375)
Timeframe: during the 1-2 hours following reversal

,,
InterventionL/min/% desaturation (Mean)
BaselineRelaxationReversal
NEOSTIGMINE0.430.290.36
PLACEBO0.660.340.49
SUGAMMADEX0.540.310.31

[back to top]

Breathing Increase Due to a Reduction in Inspired Oxygen Saturation (Hypoxic Ventilatory Response)

The ventilatory response to a decrease in oxygen saturaytion of 80% (NCT02845375)
Timeframe: 0-10 minutes following reversal

InterventionL/min/% (Mean)
PLACEBO0.49
NEOSTIGMINE0.36
SUGAMMADEX0.48

[back to top]

Number of Patients Who Experience Postoperative Nausea and Vomiting, Post-operative Pain, and Post-operative Complications

(NCT02860507)
Timeframe: through discharge from hospital, average of 72 hours

InterventionParticipants (Count of Participants)
Neostigmine + Glycopyrrolate8
Sugammadex10

[back to top]

Operating Room (OR) Turnover Time When Using Sugammadex Instead of Combination of Neostigmine and Glycopyrrolate.

(NCT02860507)
Timeframe: through start of next surgery, average of 2 hours

InterventionMinutes (Mean)
Neostigmine + Glycopyrrolate49.7
Sugammadex49.45

[back to top]

Hospital Length of Stay

Defined as the number of days between hospital admission and discharge (NCT02861131)
Timeframe: Length of hospitalization, an average of 1 week

Interventiondays (Mean)
Sugammadex4.0
Neostigmine4.5

[back to top]

Number of Participants With Residual Neuromuscular Blockade in the PACU

Residual neuromuscular blockade will be defined as a train-of-four ratio < 0.9 taken within 5 minutes of subject arrival in the PACU (NCT02861131)
Timeframe: 1 day

InterventionParticipants (Count of Participants)
Sugammadex9
Neostigmine46

[back to top]

PACU Phase 1 Recovery Time

Defined as duration of time required to attain pain control and stable respiratory, haemodynamic, and neurological status (NCT02861131)
Timeframe: 1 day

Interventionminutes (Mean)
Sugammadex97.3
Neostigmine110.0

[back to top]

Number of Participants Diagnosed With a National Surgical Quality Improvement Program (NSQIP) Defined Respiratory Complication

pneumonia, unplanned re-intubation for any reason other than a return trip to the operating room, and ventilator times greater than 48 hours - excluding operating room time (NCT02861131)
Timeframe: Length of hospitalization, an average of 1 week

InterventionParticipants (Count of Participants)
Sugammadex4
Neostigmine2

[back to top]

Number of Participants With a Postoperative Pulmonary Complication

A composite outcome which includes any of the following: postoperative pneumonia, aspiration pneumonitis, atelectasis, pneumothorax, desaturation/hypoxemia, upper airway obstruction, or acute respiratory insufficiency (NCT02861131)
Timeframe: Length of hospitalization, an average of 1 week

InterventionParticipants (Count of Participants)
Sugammadex33
Neostigmine40

[back to top]

Number of Participants With Hospital Readmission Within 30 Days

The proportion of patients that require hospital readmission for any cause within 30 days of hospital discharge (NCT02861131)
Timeframe: Length of hospitalization plus 30 days post-discharge

InterventionParticipants (Count of Participants)
Sugammadex5
Neostigmine15

[back to top]

Time to Readiness for Post Anesthesia Care Unit (PACU) Discharge (Aldrete Score >9)

Measured time between PACU admission and meeting PACU discharge readiness. PACU discharge was defined as when the patient had an Aldrete score of 9 or higher as determined by the PACU nurse. The Aldrete score is a measure of post anesthesia recovery. 0 is poor condition and 10 is excellent condition. There are 5 assessment items (able to move voluntary, breathing, consciousness, circulation (BP) and spO2) which are graded on a 0-2 point scale with 0 being poor and 2 being excellent. (NCT02909439)
Timeframe: Within 4 hours from the end of surgery

Interventionminutes (Median)
Neostigmine109
Sugammadex112

[back to top]

Train of Four Ratio > 90% During PACU Admission

Train of four ratio (TOFR) is the ration of the twitch height of the 4th twitch compared to the 1st twitch during train of four neuromuscular stimulation. This measurement was performed using a TOF Watch, which in an accelemyographer. Electric current is applied to the ulnar nevre and the twitches are measured in the thumb. Adequate reversal of neuromuscular blockade is defined as a TOFR >90%. (NCT02909439)
Timeframe: At PACU admission, approximately within one hour of reversal of neuromuscular blockade reversal.

InterventionParticipants (Count of Participants)
Neostigmine25
Sugammadex25

[back to top]

Grip Strength, Change From Baseline and Recovery Profile 120 Min

Grip strength will be measured with a hand dynamometer (NCT02909439)
Timeframe: 120 minutes after surgery

Interventionpsi (Mean)
Neostigmine7.84
Sugammadex11.85

[back to top]

Grip Strength, Change From Baseline and Recovery Profile 30 Min

Grip strength will be measured with a hand dynamometer (NCT02909439)
Timeframe: 30 minutes

InterventionPSI (Mean)
Neostigmine24.15
Sugammadex21.38

[back to top]

Grip Strength, Change From Baseline and Recovery Profile 60 Min

Grip strength will be measured with a hand dynamometer (NCT02909439)
Timeframe: 60 minutes after reversal

Interventionpsi (Mean)
Neostigmine12.68
Sugammadex17.69

[back to top]

Incentive Spirometry, Change From Baseline and Recovery Profile - 120 Minutes

Incentive spirometry measurements will be done at 30, 60 and 120 minutes after surgery. The change from baseline and recovery profile will be measured. (NCT02909439)
Timeframe: 120 minutes after reversal

InterventionmL (Median)
Neostigmine-400
Sugammadex-850

[back to top]

Incentive Spirometry, Change From Baseline and Recovery Profile - 30 Minutes

Incentive spirometry measurements will be done at 30, 60 and 120 minutes after surgery. The change from baseline and recovery profile will be measured. (NCT02909439)
Timeframe: 30 Minutes

InterventionmL (Median)
Neostigmine-700
Sugammadex-862

[back to top]

Incentive Spirometry, Change From Baseline and Recovery Profile - 60 Minutes

Incentive spirometry measurements will be done at 30, 60 and 120 minutes after surgery. The change from baseline and recovery profile will be measured. (NCT02909439)
Timeframe: 60 Minutes after reversal

InterventionmL (Median)
Neostigmine-500
Sugammadex-1150

[back to top]

Quality of Recovery 15 Survey

"15 question survey to assess patient's overall quality of recovery after anesthesia/surgery.~Quality of Recovery 15 Survey. Minimum: 0 Maximum: 150 Higher Scores mean a better outcome and better quality of recovery.~Part A: How have you been feeling in the last 24 hours? 0 = none of the time (poor), 10 = all of the time (excellent). Examples: able to breath easily, able to enjoy food, feeling rested. etc.~Part B: Have you had any of the following in the last 24 hours? 10 to 0, where 10 = none of the time (Excellent) and 0 = all of the time (poor). Examples: moderate pain, nausea or vomiting, feeling worried or anxious, etc." (NCT02909439)
Timeframe: Postoperative day number one

Interventionscores on a scale (Median)
Neostigmine117
Sugammadex105

[back to top]

Time to Extubation

Measured time between surgery end and time of extubation (removal of breathing tube) (NCT02909439)
Timeframe: Immediately after surgery, up to 30 minutes

Interventionminutes (Median)
Neostigmine8
Sugammadex7

[back to top]

Last Recorded Train-of-four (TOF) Ratio Before Tracheal Extubation or Removal of Supraglottic Airway Device in Patients Receiving a Non-depolarizing NMBA

The train-of-four (TOF) ratio is the ratio between the last and first measurements after four stimuli of the ulnar nerve at 2 Hz. The ratio should be at least 0.9 before tracheal extubation. (NCT02914119)
Timeframe: in the period from induction of anaesthesia to termination of anaesthesia, usually 2 hours

InterventionTrain-of-four ratio (Median)
Eligible Patients0.97

[back to top]

Time in Minutes From Tracheal Extubation or Removal of Supraglottic Airway Device to Discharge From Post-anaesthesia Care Unit in Cases Involving a Non-depolarizing NMBA With and Without Neuromuscular Monitoring, Respectively

(NCT02914119)
Timeframe: in the period from induction of anaesthesia to discharge from the post-anaesthesia care unit, usually 180 minutes

InterventionMinutes (Median)
Eligible Patients97

[back to top]

Number of Participants With Full Reversal of Neuromuscular Blockade Prior to Extubation

Compliance with protocol to ensure deep block or light/moderate block, using the train of four ratio and post tetanic count (NCT03034577)
Timeframe: 6 hours

Interventionparticipants (Number)
Moderate Neuromuscular Blockade Reversed With Neostigmine158
Deep Neuromuscular Blockade Reversed With Sugammadex161

[back to top]

Duration of Hospital Length of Stay

Duration of hospital length of stay following their procedure until hospital discharge (NCT03034577)
Timeframe: 3 days

Interventiondays (Mean)
Moderate Neuromuscular Blockade Reversed With Neostigmine2.6
Deep Neuromuscular Blockade Reversed With Sugammadex1.8

[back to top]

Percentage of Patients Recovered Cognitively at 1 Week

The primary outcome will be the cognitive domain at 1 week after surgery, when it is expected that most of the acute inflammation will have resolved, and analgesia requirements minimal. (NCT03034577)
Timeframe: 1 week

Interventionpercentage of patients recovered (Number)
Moderate Neuromuscular Blockade Reversed With Neostigmine91.8
Deep Neuromuscular Blockade Reversed With Sugammadex92.9

[back to top]

Percentage of Patients Recovered in All Domains of the Postoperative Quality of Recovery Scale at 3 Months After the Operation

Recovery for all domains and within domains of the PostopQRS scale at the other time points of measurement (15 minutes, 40 minutes 1 day, 3 days, 1 and 2 weeks, and 3 months following cessation of anesthesia). The domains of recovery are physiological, nociceptive, emotive activities of daily living, cognitive and overall patient perspective. (NCT03034577)
Timeframe: 3 months

Interventionpercentage of patients recovered (Number)
Moderate Neuromuscular Blockade Reversed With Neostigmine75.7
Deep Neuromuscular Blockade Reversed With Sugammadex73

[back to top]

Duration of Anesthesia From Induction to Cessation of the Anesthetic

Duration of Anesthesia from induction to cessation of the anesthetic up to 6 hours (NCT03034577)
Timeframe: Up to 6 hours

Interventionminutes (Mean)
Moderate Neuromuscular Blockade Reversed With Neostigmine165.4
Deep Neuromuscular Blockade Reversed With Sugammadex164

[back to top]

Number of Participants Categorized by Level of Surgical Satisfaction

Overall surgical satisfaction using a 1-5 Likert scale (1 = very unacceptable, 2 = unacceptable, 3 = acceptable, 4 = good, 5 = excellent). (NCT03034577)
Timeframe: 2 hours

,
Interventionparticipants (Number)
ExcellentGoodAcceptableUnacceptableVery Unacceptable
Deep Neuromuscular Blockade Reversed With Sugammadex94481611
Moderate Neuromuscular Blockade Reversed With Neostigmine104382031

[back to top]

Difference in Length of Stay in PACU

Length of PACU stay measured in minutes. (NCT03112993)
Timeframe: Day 1

Interventionminutes (Mean)
Sugammadex Group81.4
Neostigmine Group85.3

[back to top]

Difference in Time From Neuromuscular Reversal to Exit From OR

Difference in time from neuromuscular reversal to exit from OR was measured in minutes. (NCT03112993)
Timeframe: Day 1

Interventionminutes (Mean)
Sugammadex Group3.9
Neostigmine Group19.8

[back to top]

Difference in Time of Neuromuscular Recovery From a Neuromuscular Moderate Blockade

Speed of neuromuscular recovery in minutes measured by recovery of the T4:T1 ratio ≥ 0.9 (measured with a TOF-Watch SX) (NCT03112993)
Timeframe: Day 1

InterventionMinutes (Mean)
Sugammadex Group3.9
Neostigmine Group26.29

[back to top]

Difference in Time to First Ambulation After Surgery

Time from end of anesthesia to the first subject ambulation in hours. (NCT03112993)
Timeframe: From Day 1 up to 1 week, depending on individual recovery time

Interventionhours (Mean)
Sugammadex Group17.4
Neostigmine Group17.8

[back to top]

Difference in Time From Neuromuscular Reversal to Tracheal Extubation

Difference in time from neuromuscular reversal to tracheal extubation was measured in minutes. (NCT03112993)
Timeframe: Day 1

Interventionminutes (Mean)
Sugammadex Group5.3
Neostigmine Group23.6

[back to top]

Measure Participants' Recovery Time Post-Surgery

Determine whether SUG, as compared to NEO decreases time for patients to be ready for discharge from the PACU post-surgery. (NCT03116997)
Timeframe: 1 day

Interventionhours (Median)
Neuromuscular Blockade Reversed With Neostigmine/Gly3.59
Neuromuscular Blockade Reversed With Sugammadex3.62

[back to top]

PostOperative Complications

To determine if Sugammadex can improve post-operative complications for outpatient bladder procedures such as bladder perforation, nausea, vomiting, post-operative intubation and hospital admittance secondary to respiratory complications which was assessed uring follow ups on post-operative day 1 (POD1) and post-operative day 7 (POD7) looking for immediate postoperative complications such as bladder perforation, nausea, vomiting, postoperative intubation and hospital admittance secondary to respiratory complications and readmission within a week post-procedure for any other cause. (NCT03138967)
Timeframe: Post-operatively, up to 7 days

InterventionParticipants (Count of Participants)
Suggamadex or Treatment Group5
Neostigime/Glycopyrrolate or Standard of Care Group7

[back to top]

Overall Recovery Time

To determine if Sugammadex can improve overall recovery time, measured by time from end of surgery to the time patient met Discharge Criteria. (NCT03138967)
Timeframe: Up to 3 hours after end of surgery

Interventionhours (Mean)
Suggamadex or Treatment Group2.0847
Neostigime/Glycopyrrolate or Standard of Care Group2.4727

[back to top]

Muscle Recovery Time

The primary outcome is to determine if Sugammadex can improve muscle recovery time, measured by time from administration of neuromuscular blockade reversal to train-of-four ratio of 0.9 in outpatient bladder procedures. It was assessed in the intraoperative period measuring the time from administration of reversal agent to TOF of 0.9 in minutes. (NCT03138967)
Timeframe: Intraoperatively, up to 3 hours

Interventionminutes (Mean)
Suggamadex or Treatment Group2
Neostigime/Glycopyrrolate or Standard of Care Group9.24

[back to top]

Time to Complete Reversal of Neuromuscular Blockade

The time from the administration of the blinded reversal syringe until complete reversal of neuromuscular blockade (train of four ratio ≥0.9). (NCT03168308)
Timeframe: From time of reversal to complete reversal of neuromuscular blockade (train of four ratio ≥0.9), approximately 1 hour

Interventionminutes (Mean)
Neostigmine & Glycopyrrolate40
Sugammadex10

[back to top]

Number of Hypoxic Episodes

Hypoxia was defined as an episode of peripheral oxygen saturation (SpO2) <94% on ≤2 L/min of oxygen by nasal cannula, or a SpO2 <98% on ≥2 L/min of oxygen, or postoperative SpO2 of ≥5% reduction compared to preoperative values. (NCT03168308)
Timeframe: Through patient's stay in the early postoperative period, approximately 1-2 hours.

Interventionepisode(s) (Median)
Neostigmine & Glycopyrrolate1
Sugammadex0

[back to top]

Number of Participants Who Needed Rescue Sugammadex After Initial Reversal of Neuromuscular Blockade

To determine if reversal with sugammadex versus neostigmine requires an additional dose of sugammadex rescue after initial reversal of neuromuscular blockade. (NCT03168308)
Timeframe: From time of reversal to 80 minutes after arrival in the post-anesthesia care unit, approximately 1-2 hours.

InterventionParticipants (Count of Participants)
Neostigmine & Glycopyrrolate5
Sugammadex0

[back to top]

Percentage of Participants With Nausea and/or Vomiting in PACU

Degree of Post-Operative Nausea determined per Visual Analog Scale per nurse in Post-Anesthesia Care Unit (PACU). (NCT03210376)
Timeframe: Day 0 - PACU stay, an average of 120 minutes

,
Interventionpercentage of participants (Number)
NauseaVomiting
Deep Neuromuscular Blockade (NMB) + Sugammadex71
Moderate Neuromuscular Blockade (NMB) + Neostigmine60

[back to top]

Readiness to Discharge From the Post-Anesthesia Care Unit (PACU)

Determined by the Dansk Selskab for Anæstesiologi og Intensiv Medicin(DASAIM)discharge criteria.Pts considered ready to discharge when the sum of all categories is<4 and no single category has a score of >1.Sedation.0:Patient is fully awake.1: Patient is asleep,aroused by verbal stimulation.2:Patient is asleep, aroused by physical stimulation.3:Patient is asleep,cannot be aroused.Respiratory Rate.0:Respiratory rate>10. 1: Snoring,10< RR<30. 2:R<10 or RR>30/min.3:Periods of apnea or obstructive patterns.Oxygen Saturation.0:SpO2 ≥ 94%.1:90%≤SpO2<94%. 2:85%≤ SpO2 < 90%.3:SpO2 < 85%. Systolic Blood Pressure. 0:SBP ≥ 100mmHg.1:90mmHg≤SBP< 100mmHg.2:80mmHg≤SBP< 90mmHg or SBP>220mmHg.3:SBP<80mmHg.Heart Rate.0:50130.Pain at rest.0:No pain 1:Light pain.2:Moderate pain.3:Severe pain.Nausea.0:No nausea or vomiting.1:Light nausea or vomiting without previous nausea. 2:Moderate nausea and/or vomiting.3:Severe nausea and/or vomiting. (NCT03210376)
Timeframe: Assessed at 15, 45, 90 minutes during PACU stay.

,
InterventionScore on a scale (Median)
DASAIM at 15 minDASAIM at 45 minDASAIM at 90 min
Deep Neuromuscular Blockade (NMB) + Sugammadex2.922.822.12
Moderate Neuromuscular Blockade (NMB) + Neostigmine3.162.861.8

[back to top]

Surgical Exposure Grading

(NCT03210376)
Timeframe: Day 0 - IntraOperative, from incision time to closing time(average 190 minutes)

,
InterventionParticipants (Count of Participants)
OptimalGoodAcceptablePoor
Deep Neuromuscular Blockade (NMB) + Sugammadex251951
Moderate Neuromuscular Blockade (NMB) + Neostigmine33881

[back to top]

Cumulative Intraoperative Insufflation Pressure

Intra-abdominal insufflation time and pressure directed by the surgeon and recorded continuously by the clinical coordinator until the time of desufflation. (NCT03210376)
Timeframe: Day 0 - IntraOperative-From beginning of pneumoperitoneum to desufflation (an average of 166 minutes)

InterventionmmHg (Median)
Deep Neuromuscular Blockade (NMB) + Sugammadex1995
Moderate Neuromuscular Blockade (NMB) + Neostigmine1581

[back to top]

Length of Hospital Stay

(NCT03210376)
Timeframe: length of hospital stay(average of 3 days)

Interventiondays (Mean)
Deep Neuromuscular Blockade (NMB) + Sugammadex2.2323
Moderate Neuromuscular Blockade (NMB) + Neostigmine1.8623

[back to top]

Percentage of Muscle Response Using Train-of-Four (TOF) in Post-Anesthesia Care Unit (PACU) to Measure Residual Muscle Relaxation

The patients will be started on a continuous Rocuronium intravenous infusion following intubation. Insert recommendations and Institutional Standards will be used for Rocuronium. For the DNMB group, the rate will be adjusted and boluses given to maintain 1-2 post tetanic responses during the pneumoperitoneum. NMB will be reversed with Sugammadex 4 mg/Kg, intravenously as a single bolus injection, at the end of the surgery. Percentage of measured contraction strength of the fourth stimulus compared to the first stimulus. (NCT03210376)
Timeframe: Day 0 - Arrival time at PACU, an average of 3 minutes

InterventionPercentage of measured contraction (Median)
Deep Neuromuscular Blockade (NMB) + Sugammadex110
Moderate Neuromuscular Blockade (NMB) + Neostigmine100

[back to top]

Percentage of Patients Who Reported Shoulder Pain

Visual Analog Scale (VAS) pain score (0-10) for shoulder pain recorded, where 0 means no pain and 10 means the worst pain ever experienced . Percentage of participants who experienced should pain. (NCT03210376)
Timeframe: 30 days

Interventionpercentage of participants (Number)
Deep Neuromuscular Blockade (NMB) + Sugammadex12
Moderate Neuromuscular Blockade (NMB) + Neostigmine10

[back to top]

Pediatric Anesthesia Emergence Delirium Score

Maximum Pediatric Anesthesia Emergence Delirium (PAED) score after arrival in the PACU.Higher values represent more emergence delirium (worse) PAED Score is represented with total PAED score summed up of subscales. The total score is reported and it ranges from 0 to 20. Higher score means worse state. (NCT03229486)
Timeframe: within 30 minutes after arrival at post-anesthesia care unit (PACU)

Interventionunits on a scale (Median)
Sugammadex18
Neostigmine18

[back to top]

Time to Regular Breathing

time from administration of reversal agent to time of deep, regular breathing (NCT03229486)
Timeframe: time from administration of reversal agent to time of deep, regular breathing, assessed up to 60 minutes

Interventionseconds (Mean)
Sugammadex273.8
Neostigmine345.1

[back to top]

Time to Awakening

time from administration of reversal agent to time of eye opening or child showing purposeful movement (NCT03229486)
Timeframe: time from administration of reversal agent to time of eye opening or child showing purposeful movements, assessed up to 60 minutes

Interventionseconds (Mean)
Sugammadex275.8
Neostigmine371.2

[back to top]

Time Recovery of TOF Ratio to 0.9

Time from the start of administration of reversal agents to recovery of the TOF ratio to 0.9 (NCT03229486)
Timeframe: Time from the start of administration of reversal agents to recovery of the TOF ratio to 0.9, assessed up to 60 minutes

Interventionseconds (Mean)
Sugammadex99.6
Neostigmine253.1

[back to top]

Time Recovery of TOF Ratio to 0.8

Time from the start of administration of reversal agents to recovery of the TOF ratio to 0.8 (NCT03229486)
Timeframe: Time from the start of administration of reversal agents to recovery of the TOF ratio to 0.8, assessed up to 60 minutes

Interventionseconds (Mean)
Sugammadex83.9
Neostigmine213.6

[back to top]

Time Recovery of TOF Ratio to 0.7

Time from the start of administration of reversal agents to recovery of the TOF ratio to 0.7 (NCT03229486)
Timeframe: Time from the start of administration of reversal agents to recovery of the TOF ratio to 0.7, assessed up to 60 minutes

Interventionseconds (Mean)
Sugammadex72.7
Neostigmine167.4

[back to top]

Time to Extubation

time from administration of reversal agent to time of tracheal extubation (NCT03229486)
Timeframe: time from administration of reversal agent to time of tracheal extubation, assessed up to 60 minutes

Interventionseconds (Mean)
Sugammadex312.1
Neostigmine427.3

[back to top]

Post Anesthesia Care Unit Length of Stay

Determine the difference in length of stay in the post anesthesia care unit from patient arrival until ready for post anesthesia care discharge for the American Society of Anesthesiologists Score II and III patients reversed with Sugammadex versus Neostigmine in sleeve gastrectomy surgeries. (NCT03276026)
Timeframe: Observations will be made during each patient's stay in the post anesthesia care unit (about 120 minutes).

Interventionminutes (Mean)
Control Group/Neostigmine121
Study Group/Sugammadex119

[back to top]

Change of Diaphragmatic Contractility Speed, Deep Breathing From Mouth, cm/s

The change of diaphragmatic contractility speed was defined as baseline minus postoperative diaphragmatic contraction. (NCT03322657)
Timeframe: from baseline to 90 minutes after the administration of reversal agent

Interventioncm/s (Mean)
Neostigmine With Glycopyrrolate-0.02
Sugammadex0.80

[back to top]

The Time for Extubation After Administration of Reversal Agents

Time from administration of reversal agent to tracheal extubation (NCT03322657)
Timeframe: Up to 4 hours after administration of reversal agents

Interventionminutes (Median)
Neostigmine With Glycopyrrolate8
Sugammadex8

[back to top]

TOF Ratio at 90 Min

"TOF (train of four), also known as a peripheral nerve stimulator, is used to assess nerve function in patients receiving neuromuscular blocking agents (paralytic medications). Before giving the medications, the baseline must be measured because this tells how much electrical stimulation the patient needs for nerve stimulation without any paralytic on board.~Our primary outcome TOF ratio between TOF at 90 minutes after the administration of the reversal agent versus the TOF at baseline tells us how well the treatment is working to reverse the rocuronium Neuromuscular. This is a sensitivity analysis of primary analysis." (NCT03322657)
Timeframe: at 90 minutes after the administration of the reversal agent

Interventionratio (Median)
Neostigmine With Glycopyrrolate1.07
Sugammadex1.16

[back to top]

Time in Minutes to Reach Train of Four (TOF) Ratio ≥ 0.9 After the Administration of Reversal Agent

The primary outcome was a time-to-TOF ratio ≥ 0.9 after the administration of the reversal agent. The TOF ratio was measured in a continuous manner every 12 seconds from the administration of the reversal drug until TOF ratio ≥ 0.9 or until 90 minutes after administration of the reversal agent. (NCT03322657)
Timeframe: within 90 minutes after endotracheal extubation

Interventionminutes (Median)
Neostigmine With Glycopyrrolate8
Sugammadex3

[back to top]

Change of Diaphragmatic Contractility Speed- Sniff (Breathing From the Nose), cm/s

The change of diaphragmatic contractility speed was defined as baseline minus postoperative diaphragmatic contraction. (NCT03322657)
Timeframe: from baseline to 90 minutes after the administration of the reversal agent

Interventioncm/s (Mean)
Neostigmine With Glycopyrrolate-0.04
Sugammadex0.29

[back to top]

Percentage of Participants With Treatment-Emergent Sinus Bradycardia Events

The percentage of participants experiencing treatment-emergent sinus bradycardia events was identified with continuous electrocardiogram (ECG) monitoring. Treatment-emergent sinus bradycardia were defined as a heart rate <60 bpm that has also decreased more than 20% compared to participant baseline heart rate value, sustained for at least 1 minute after administration of study intervention. Treatment-emergent sinus bradycardia events may or may not have been considered an adverse event (AE), as determined by investigator judgment. (NCT03346057)
Timeframe: Up to approximately 35 minutes post-administration

InterventionPercentage of participants (Number)
Sugammadex 2 mg/kg1.0
Sugammadex 4 mg/kg1.9
Sugammadex 16 mg/kg7.4
Neostigmine + Glycopyrrolate7.8

[back to top]

Percentage of Participants Experiencing a Serious Adverse Event (SAE) Up To 7 Days After Administration of Study Intervention

As per the protocol primary analysis, the percentage of participants experiencing an SAE up to 7 days after administration of study intervention was reported. An SAE was an adverse event that: resulted in death; was life threatening; resulted in persistent or significant disability or incapacity; resulted in or prolonged an existing inpatient hospitalization; was a congenital anomaly or birth defect; was an other important medical event, was a cancer; or was associated with an overdose. (NCT03346057)
Timeframe: Up to 7 days

InterventionPercentage of Participants (Number)
Sugammadex 2 mg/kg11.4
Sugammadex 4 mg/kg7.5
Sugammadex 16 mg/kg10.3
Neostigmine + Glycopyrrolate5.9

[back to top]

Percentage of Participants With Treatment-Emergent Sinus Tachycardia Events

The percentage of participants experiencing treatment-emergent sinus tachycardia events was identified with continuous ECG monitoring. Treatment-emergent sinus tachycardia is defined as a heart rate ≥100 bpm that has also increased more than 20% compared to participant baseline heart rate value, sustained for at least 1 minute after administration of study intervention. Treatment-emergent sinus tachycardia events may or may not have been considered an AE, as determined by investigator judgment. (NCT03346057)
Timeframe: Up to approximately 35 minutes post-administration

InterventionPercentage of participants (Number)
Sugammadex 2 mg/kg6.7
Sugammadex 4 mg/kg9.3
Sugammadex 16 mg/kg8.8
Neostigmine + Glycopyrrolate21.6

[back to top]

Percentage of Participants Experiencing an Event of Clinical Interest (ECI) Up To 7 Days After Administration of Study Intervention

As per the protocol primary analysis, the percentage of participants experiencing an ECI up to 7 days after administration of study intervention was reported. ECIs were a discrete set of both AEs and SAEs, specifically designated as such for the trial. For the purposes of this investigation, ECIs included 1) drug-induced liver injury; 2) clinically-relevant arrhythmias, inclusive of bradycardia and tachycardia defined as events necessitating intervention, as determined by investigator judgment; and 3) instances of hypersensitivity and/or anaphylaxis adjudicated by an external expert Adjudication Committee. A participant could have experienced more than one type of ECI. (NCT03346057)
Timeframe: Up to 7 days

,,,
InterventionPercentage of Participants (Number)
With one or more ECIsAdjudicated HypersensitivityAdjudicated AnaphylaxisClinically Relevant BradycardiaClinically Relevant TachycardiaOther Clinically Relevant Cardiac ArrhythmiaDrug Induced Liver Injury
Neostigmine + Glycopyrrolate3.90.00.02.00.02.00.0
Sugammadex 16 mg/kg7.40.00.00.05.91.50.0
Sugammadex 2 mg/kg1.90.00.00.01.90.00.0
Sugammadex 4 mg/kg5.60.00.02.81.90.90.0

[back to top]

Percentage of Participants With Other Treatment-Emergent Cardiac Arrhythmia Events

The percentage of participants experiencing other treatment-emergent cardiac arrhythmia events was identified with continuous ECG monitoring. Other treatment-emergent cardiac arrhythmias were defined as new or worsening arrhythmias (e.g., atrial fibrillation, atrial tachycardia, ventricular fibrillation, or ventricular tachyarrhythmia), sustained for at least 1 minute after administration of study intervention. Worsening arrhythmia events may or may not have been considered an AE, as determined by investigator judgment. (NCT03346057)
Timeframe: Up to approximately 35 minutes post-administration

InterventionPercentage of participants (Number)
Sugammadex 2 mg/kg1.0
Sugammadex 4 mg/kg0.0
Sugammadex 16 mg/kg1.5
Neostigmine + Glycopyrrolate2.0

[back to top]

Percentage of Participants Experiencing an Adverse Event (AE) Up To 7 Days After Administration of Study Intervention

As per the protocol primary analysis, the percentage of participants experiencing an AE up to 7 days after administration of study intervention was reported. An AE was defined as any untoward medical occurrence in a participant which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that was temporally associated with the use of the Sponsor's product was also an AE. (NCT03346057)
Timeframe: Up to 7 days

InterventionPercentage of participants (Number)
Sugammadex 2 mg/kg94.3
Sugammadex 4 mg/kg88.8
Sugammadex 16 mg/kg92.6
Neostigmine + Glycopyrrolate88.2

[back to top]

Time to Recovery (TTR) of Participant Train of Four (TOF) Ratio to ≥0.8: Geometric Mean Analysis

The efficacy analysis of TTR of participant TOF ratio to ≥0.8 was performed by estimating the geometric mean of TTR within each treatment group. TTR was monitored by applying electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to magnitudes of the first and fourth twitches respectively, after nerve stimulation. The T4/T1 ratio (TOF; expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB. A faster TTR of the TOF ratio to 0.8 indicates faster recovery from NMB. As specified by the protocol, analyses for this outcome measure were conducted in participants pooled by dosing method across depth of NMB (Sugammadex ABW [2 mg/kg ABW plus 4 mg/kg ABW] and Sugammadex IBW [2 mg/kg IBW plus 4 mg/kg IBW]) as well as in all randomized treatment arms separated by depth of NMB (Sugammadex 2 mg/kg ABW, Sugammadex 4 mg/kg ABW, Sugammadex 2 mg/kg IBW, and Sugammadex 4 mg/kg IBW). (NCT03346070)
Timeframe: Up to 69 minutes

InterventionMinutes (Geometric Mean)
Sugammadex 2 mg/kg ABW1.6
Sugammadex 4 mg/kg ABW1.5
Sugammadex ABW (2 mg/kg ABW Plus 4 mg/kg ABW)1.5
Sugammadex 2 mg/kg IBW2.5
Sugammadex 4 mg/kg IBW2.6
Sugammadex IBW (2 mg/kg IBW Plus 4 mg/kg IBW)2.5
Neostigmine/Glycopyrrolate16.6

[back to top]

Time to Recovery (TTR) of Participant Train Of Four (TOF) Ratio to ≥0.9: Primary Kaplan-Meier Analysis

The primary efficacy analysis of TTR of TOF ratio to ≥0.9 was performed by estimating event rates within each treatment group using the Kaplan-Meier method. TTR was monitored by applying electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to magnitudes of the first and fourth twitches respectively, after nerve stimulation. The T4/T1 ratio (TOF; expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB. A faster TTR of the TOF ratio to 0.9 indicates faster recovery from NMB. As specified by the protocol, analyses for this outcome measure were conducted in participants pooled by dosing method across depth of NMB (Sugammadex ABW [2 mg/kg ABW plus 4 mg/kg ABW] and Sugammadex IBW [2 mg/kg IBW plus 4 mg/kg IBW]) as well as in all randomized treatment arms separated by depth of NMB (Sugammadex 2 mg/kg ABW, Sugammadex 4 mg/kg ABW, Sugammadex 2 mg/kg IBW, and Sugammadex 4 mg/kg IBW). (NCT03346070)
Timeframe: Up to 76 minutes

InterventionMinutes (Median)
Sugammadex 2 mg/kg ABW1.7
Sugammadex 4 mg/kg ABW1.8
Sugammadex ABW (2 mg/kg ABW Plus 4 mg/kg ABW)1.8
Sugammadex 2 mg/kg IBW3.4
Sugammadex 4 mg/kg IBW3.3
Sugammadex IBW (2 mg/kg IBW Plus 4 mg/kg IBW)3.3
Neostigmine/Glycopyrrolate34.5

[back to top]

Percentage of Participants With Prolonged (>10 Minutes) Time to Recovery (TTR) of the Train Of Four (TOF) Ratio to ≥0.9

Following administration of study intervention, the percentage of participants experiencing prolonged (>10 minutes) recovery to a TOF ratio ≥0.9 was calculated. TTR was monitored by applying electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to magnitudes of the first and fourth twitches respectively, after nerve stimulation. The T4/T1 ratio (TOF; expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB. A faster TTR of the TOF ratio to 0.9 indicates faster recovery from NMB. As specified by the protocol, analyses for this outcome measure were conducted in participants pooled by dosing method across depth of NMB (Sugammadex ABW [2 mg/kg ABW plus 4 mg/kg ABW] and Sugammadex IBW [2 mg/kg IBW plus 4 mg/kg IBW]) as well as in all randomized treatment arms separated by depth of NMB (Sugammadex 2 mg/kg ABW, Sugammadex 4 mg/kg ABW, Sugammadex 2 mg/kg IBW, and Sugammadex 4 mg/kg IBW). (NCT03346070)
Timeframe: Up to 76 minutes

InterventionPercentage of participants (Number)
Sugammadex 2 mg/kg ABW7.9
Sugammadex 4 mg/kg ABW2.7
Sugammadex ABW (2 mg/kg ABW Plus 4 mg/kg ABW)5.3
Sugammadex 2 mg/kg IBW5.4
Sugammadex 4 mg/kg IBW0.0
Sugammadex IBW (2 mg/kg IBW Plus 4 mg/kg IBW)2.7
Neostigmine/Glycopyrrolate84.2

[back to top]

Percentage of Participants With Other Treatment-Emergent Cardiac Arrhythmia Events

The percentage of participants experiencing other treatment-emergent cardiac arrhythmia events were identified with continuous ECG monitoring. Other treatment-emergent cardiac arrhythmias are defined as new or worsening arrhythmias (e.g., atrial fibrillation, atrial tachyarrhythmia, ventricular fibrillation, or ventricular tachyarrhythmia), sustained for at least 1 minute after administration of study intervention. Worsening arrhythmia events may or may not be considered an AE, as determined by investigator judgment. As specified by the protocol, analyses for this outcome measure were conducted in participants pooled by dosing method across depth of NMB (Sugammadex ABW [2 mg/kg ABW plus 4 mg/kg ABW] and Sugammadex IBW [2 mg/kg IBW plus 4 mg/kg IBW]) as well as in all randomized treatment arms separated by depth of NMB (Sugammadex 2 mg/kg ABW, Sugammadex 4 mg/kg ABW, Sugammadex 2 mg/kg IBW, and Sugammadex 4 mg/kg IBW). (NCT03346070)
Timeframe: Up to 35 minutes

InterventionPercentage of participants (Number)
Sugammadex 2 mg/kg ABW0.0
Sugammadex 4 mg/kg ABW0.0
Sugammadex ABW (2 mg/kg ABW Plus 4 mg/kg ABW)0.0
Sugammadex 2 mg/kg IBW2.6
Sugammadex 4 mg/kg IBW0.0
Sugammadex IBW (2 mg/kg IBW Plus 4 mg/kg IBW)1.4
Neostigmine/Glycopyrrolate2.6

[back to top]

Percentage of Participants Experiencing a Serious Adverse Event (SAE) After Administration of Study Intervention

The percentage of participants experiencing an SAE following administration of study intervention was monitored. An SAE is an adverse event that: results in death; is life threatening; results in persistent or significant disability or incapacity; results in or prolongs a hospitalization; is a congenital anomaly or birth defect; is a cancer; or may jeopardize the participant, potentially requiring medical or surgical intervention. As specified by the protocol, analyses for this outcome measure were conducted in participants pooled by dosing method across depth of NMB (Sugammadex ABW [2 mg/kg ABW plus 4 mg/kg ABW] and Sugammadex IBW [2 mg/kg IBW plus 4 mg/kg IBW]) as well as in all randomized treatment arms separated by depth of NMB (Sugammadex 2 mg/kg ABW, Sugammadex 4 mg/kg ABW, Sugammadex 2 mg/kg IBW, and Sugammadex 4 mg/kg IBW). (NCT03346070)
Timeframe: Up to 7 days

InterventionPercentage of participants (Number)
Sugammadex 2 mg/kg ABW2.6
Sugammadex 4 mg/kg ABW0.0
Sugammadex ABW (2 mg/kg ABW Plus 4 mg/kg ABW)1.3
Sugammadex 2 mg/kg IBW5.3
Sugammadex 4 mg/kg IBW8.3
Sugammadex IBW (2 mg/kg IBW Plus 4 mg/kg IBW)6.8
Neostigmine/Glycopyrrolate7.9

[back to top]

Percentage of Participants With Treatment-Emergent Sinus Bradycardia Events

The percentage of participants experiencing treatment-emergent bradycardia events were identified with continuous electrocardiogram (ECG) monitoring. Treatment-emergent sinus bradycardia is defined as a heart rate <60 bpm that has also decreased more than 20% compared to participant baseline heart rate value, sustained for at least 1 minute after administration of study intervention. Treatment-emergent sinus bradycardia events may or may not be considered an adverse event (AE), as determined by investigator judgment. As specified by the protocol, analyses for this outcome measure were conducted in participants pooled by dosing method across depth of NMB (Sugammadex ABW [2 mg/kg ABW plus 4 mg/kg ABW] and Sugammadex IBW [2 mg/kg IBW plus 4 mg/kg IBW]) as well as in all randomized treatment arms separated by depth of NMB (Sugammadex 2 mg/kg ABW, Sugammadex 4 mg/kg ABW, Sugammadex 2 mg/kg IBW, and Sugammadex 4 mg/kg IBW). (NCT03346070)
Timeframe: Up to 35 minutes

InterventionPercentage of participants (Number)
Sugammadex 2 mg/kg ABW5.3
Sugammadex 4 mg/kg ABW5.3
Sugammadex ABW (2 mg/kg ABW Plus 4 mg/kg ABW)5.3
Sugammadex 2 mg/kg IBW2.6
Sugammadex 4 mg/kg IBW5.6
Sugammadex IBW (2 mg/kg IBW Plus 4 mg/kg IBW)4.1
Neostigmine/Glycopyrrolate2.6

[back to top]

Percentage of Participants With Treatment-Emergent Sinus Tachycardia Events

The percentage of participants experiencing treatment-emergent sinus tachycardia events were identified with continuous ECG monitoring. Treatment-emergent sinus tachycardia is defined as a heart rate ≥100 bpm that has also increased more than 20% compared to participant baseline heart rate value, sustained for at least 1 minute after administration of study intervention. Treatment-emergent sinus tachycardia events may or may not be considered an AE, as determined by investigator judgment. As specified by the protocol, analyses for this outcome measure were conducted in participants pooled by dosing method across depth of NMB (Sugammadex ABW [2 mg/kg ABW plus 4 mg/kg ABW] and Sugammadex IBW [2 mg/kg IBW plus 4 mg/kg IBW]) as well as in all randomized treatment arms separated by depth of NMB (Sugammadex 2 mg/kg ABW, Sugammadex 4 mg/kg ABW, Sugammadex 2 mg/kg IBW, and Sugammadex 4 mg/kg IBW). (NCT03346070)
Timeframe: Up to 35 minutes

InterventionPercentage of participants (Number)
Sugammadex 2 mg/kg ABW10.5
Sugammadex 4 mg/kg ABW13.2
Sugammadex ABW (2 mg/kg ABW Plus 4 mg/kg ABW)11.8
Sugammadex 2 mg/kg IBW7.9
Sugammadex 4 mg/kg IBW2.8
Sugammadex IBW (2 mg/kg IBW Plus 4 mg/kg IBW)5.4
Neostigmine/Glycopyrrolate7.9

[back to top]

Time to Recovery (TTR) of Participant Train of Four (TOF) Ratio to ≥0.7: Geometric Mean Analysis

The efficacy analysis of TTR of participant TOF ratio to ≥0.7 was performed by estimating the geometric mean of TTR within each treatment group. TTR was monitored by applying electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to magnitudes of the first and fourth twitches respectively, after nerve stimulation. The T4/T1 ratio (TOF; expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB. A faster TTR of the TOF ratio to 0.7 indicates faster recovery from NMB. As specified by the protocol, analyses for this outcome measure were conducted in participants pooled by dosing method across depth of NMB (Sugammadex ABW [2 mg/kg ABW plus 4 mg/kg ABW] and Sugammadex IBW [2 mg/kg IBW plus 4 mg/kg IBW]) as well as in all randomized treatment arms separated by depth of NMB (Sugammadex 2 mg/kg ABW, Sugammadex 4 mg/kg ABW, Sugammadex 2 mg/kg IBW, and Sugammadex 4 mg/kg IBW). (NCT03346070)
Timeframe: Up to 61 minutes

InterventionMinutes (Geometric Mean)
Sugammadex 2 mg/kg ABW1.4
Sugammadex 4 mg/kg ABW1.3
Sugammadex ABW (2 mg/kg ABW Plus 4 mg/kg ABW)1.4
Sugammadex 2 mg/kg IBW2.1
Sugammadex 4 mg/kg IBW2.0
Sugammadex IBW (2 mg/kg IBW Plus 4 mg/kg IBW)2.1
Neostigmine/Glycopyrrolate10.9

[back to top]

Time to Recovery (TTR) of Participant Train of Four (TOF) Ratio to ≥0.9: Secondary Geometric Mean Analysis

The secondary efficacy analysis of TTR of participant TOF ratio to ≥0.9 was performed by estimating the geometric mean of TTR within each treatment group. TTR was monitored by applying electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to magnitudes of the first and fourth twitches respectively, after nerve stimulation. The T4/T1 ratio (TOF; expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB. A faster TTR of the TOF ratio to 0.9 indicates faster recovery from NMB. As specified by the protocol, analyses for this outcome measure were conducted in participants pooled by dosing method across depth of NMB (Sugammadex ABW [2 mg/kg ABW plus 4 mg/kg ABW] and Sugammadex IBW [2 mg/kg IBW plus 4 mg/kg IBW]) as well as in all randomized treatment arms separated by depth of NMB (Sugammadex 2 mg/kg ABW, Sugammadex 4 mg/kg ABW, Sugammadex 2 mg/kg IBW, and Sugammadex 4 mg/kg IBW). (NCT03346070)
Timeframe: Up to 76 minutes

InterventionMinutes (Geometric Mean)
Sugammadex 2 mg/kg ABW2.0
Sugammadex 4 mg/kg ABW1.9
Sugammadex ABW (2 mg/kg ABW Plus 4 mg/kg ABW)2.0
Sugammadex 2 mg/kg IBW3.2
Sugammadex 4 mg/kg IBW3.5
Sugammadex IBW (2 mg/kg IBW Plus 4 mg/kg IBW)3.3
Neostigmine/Glycopyrrolate23.1

[back to top]

Percentage of Participants Experiencing an Event of Clinical Interest (ECI) After Administration of Study Intervention

The percentage of participants experiencing an ECI following administration of study intervention was monitored. ECIs are a discrete set of both AEs and SAEs, specifically designated as such for the trial. For the purposes of this investigation, ECIs included 1) drug-induced liver injury; 2) clinically-relevant arrhythmias, inclusive of bradycardia and tachycardia defined as events necessitating intervention, as determined by investigator judgment; and 3) instances of hypersensitivity and/or anaphylaxis adjudicated by an external expert Adjudication Committee. As specified by the protocol, analyses for this outcome measure were conducted in participants pooled by dosing method across depth of NMB (Sugammadex ABW [2 mg/kg ABW plus 4 mg/kg ABW] and Sugammadex IBW [2 mg/kg IBW plus 4 mg/kg IBW]) as well as in all randomized treatment arms separated by depth of NMB (Sugammadex 2 mg/kg ABW, Sugammadex 4 mg/kg ABW, Sugammadex 2 mg/kg IBW, and Sugammadex 4 mg/kg IBW). (NCT03346070)
Timeframe: Up to 7 days

InterventionPercentage of participants (Number)
Sugammadex 2 mg/kg ABW0.0
Sugammadex 4 mg/kg ABW2.6
Sugammadex ABW (2 mg/kg ABW Plus 4 mg/kg ABW)1.3
Sugammadex 2 mg/kg IBW2.6
Sugammadex 4 mg/kg IBW2.8
Sugammadex IBW (2 mg/kg IBW Plus 4 mg/kg IBW)2.7
Neostigmine/Glycopyrrolate2.6

[back to top]

Percentage of Participants Experiencing an Adverse Event (AE) After Administration of Study Intervention

The percentage of participants experiencing an AE following administration of study intervention was monitored. An AE is any unfavorable and unintended medical occurrence, symptom, or disease witnessed in a participant, regardless of whether or not a causal relationship with the study treatment can be demonstrated. Further, any worsening (i.e. any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of the study treatment is also considered an AE. As specified by the protocol, analyses for this outcome measure were conducted in participants pooled by dosing method across depth of NMB (Sugammadex ABW [2 mg/kg ABW plus 4 mg/kg ABW] and Sugammadex IBW [2 mg/kg IBW plus 4 mg/kg IBW]) as well as in all randomized treatment arms separated by depth of NMB (Sugammadex 2 mg/kg ABW, Sugammadex 4 mg/kg ABW, Sugammadex 2 mg/kg IBW, and Sugammadex 4 mg/kg IBW). (NCT03346070)
Timeframe: Up to 7 days

InterventionPercentage of participants (Number)
Sugammadex 2 mg/kg ABW94.7
Sugammadex 4 mg/kg ABW86.8
Sugammadex ABW (2 mg/kg ABW Plus 4 mg/kg ABW)90.8
Sugammadex 2 mg/kg IBW94.7
Sugammadex 4 mg/kg IBW91.7
Sugammadex IBW (2 mg/kg IBW Plus 4 mg/kg IBW)93.2
Neostigmine/Glycopyrrolate89.5

[back to top]

Apparent Volume of Distribution (Vz) of Sugammadex [Part A]

The Vz of sugammadex, defined as the amount of drug administered relative to plasma concentrations, was determined in each Part A arm. (NCT03351608)
Timeframe: 2 minutes (min), 15 min, 30 min, 60 min, 4-6 hours (hrs), and 10 hrs post-dose

InterventionLiters (Geometric Mean)
Part A: Sugammadex 2 mg (2 to <6 Years)3.58
Part A: Sugammadex 2 mg (6 to <12 Years)6.65
Part A: Sugammadex 2 mg (12 to <17 Years)10.8
Part A: Sugammadex 4 mg (2 to <6 Years)4.00
Part A: Sugammadex 4 mg (6 to <12 Years)8.22
Part A: Sugammadex 4 mg (12 to <17 Years)12.3

[back to top]

Time to Recovery of Participant Train-of-Four (TOF) Ratio to ≥0.9 [Part B]

The time to recovery of TOF ratio to ≥0.9 after administration of study intervention was determined for each Part B arm. The TOF ratio is the ratio of the magnitude of the fourth (T4) and first (T1) thumb twitches elicited by 4 electrical stimulations of the ulnar nerve, indicating the current degree of NMB as a decimal from 0 (loss of T4 twitch) to 1 (no NMB). Values closer to 1 indicate less NMB. Per protocol, the efficacy analysis is based on comparison of the Part B: Sugammadex 2 mg arm versus the Part B: Neostigmine + (Glycopyrrolate or Atropine) arm. (NCT03351608)
Timeframe: Up to 30 minutes post-dose

InterventionMinutes (Geometric Mean)
Part B: Sugammadex 2 mg/kg1.6
Part B: Sugammadex 4 mg/kg1.9
Part B: Neostigmine + (Glycopyrrolate or Atropine)7.5

[back to top]

Time to Recovery of Participant TOF Ratio to ≥0.8 [Part B]

The time to recovery of TOF ratio to ≥0.8 after administration of study intervention was determined for each Part B arm. The TOF ratio is the ratio of the magnitude of the fourth (T4) and first (T1) thumb twitches elicited by 4 electrical stimulations of the ulnar nerve, indicating the current degree of NMB as a decimal from 0 (loss of T4 twitch) to 1 (no NMB). Values closer to 1 indicate less NMB. (NCT03351608)
Timeframe: Up to 30 minutes post-dose

InterventionMinutes (Geometric Mean)
Part B: Sugammadex 2 mg/kg1.3
Part B: Sugammadex 4 mg/kg1.5
Part B: Neostigmine + (Glycopyrrolate or Atropine)5.0

[back to top]

Time to Recovery of Participant TOF Ratio to ≥0.7 [Part B]

The time to recovery of TOF ratio to ≥0.7 after administration of study intervention was determined for each Part B arm. The TOF ratio is the ratio of the magnitude of the fourth (T4) and first (T1) thumb twitches elicited by 4 electrical stimulations of the ulnar nerve, indicating the current degree of NMB as a decimal from 0 (loss of T4 twitch) to 1 (no NMB). Values closer to 1 indicate less NMB. (NCT03351608)
Timeframe: Up to 30 minutes post-dose

InterventionMinutes (Geometric Mean)
Part B: Sugammadex 2 mg/kg1.1
Part B: Sugammadex 4 mg/kg1.3
Part B: Neostigmine + (Glycopyrrolate or Atropine)3.7

[back to top]

Plasma Half-Life (t½) of Sugammadex [Part A]

The t½ of sugammadex, defined as the time required for the plasma concentration to decrease to 50% of maximum, was determined in each Part A arm. (NCT03351608)
Timeframe: 2 minutes (min), 15 min, 30 min, 60 min, 4-6 hours (hrs), and 10 hrs post-dose

InterventionHours (Median)
Part A: Sugammadex 2 mg (2 to <6 Years)1.15
Part A: Sugammadex 2 mg (6 to <12 Years)1.19
Part A: Sugammadex 2 mg (12 to <17 Years)1.49
Part A: Sugammadex 4 mg (2 to <6 Years)1.12
Part A: Sugammadex 4 mg (6 to <12 Years)1.56
Part A: Sugammadex 4 mg (12 to <17 Years)1.51

[back to top]

Plasma Clearance (CL) of Sugammadex [Part A]

The CL of sugammadex, defined as the rate of elimination relative to plasma concentration, was determined in each Part A arm. (NCT03351608)
Timeframe: 2 minutes (min), 15 min, 30 min, 60 min, 4-6 hours (hrs), and 10 hrs post-dose

InterventionL/hr (Geometric Mean)
Part A: Sugammadex 2 mg (2 to <6 Years)2.30
Part A: Sugammadex 2 mg (6 to <12 Years)3.58
Part A: Sugammadex 2 mg (12 to <17 Years)4.68
Part A: Sugammadex 4 mg (2 to <6 Years)2.26
Part A: Sugammadex 4 mg (6 to <12 Years)3.43
Part A: Sugammadex 4 mg (12 to <17 Years)5.69

[back to top]

Percentage of Participants With ≥1 Adverse Event (AE) [Parts A and B]

The percentage of participants with ≥1 AE(s) for up to 7 days after treatment was determined for each treatment group, pooled according to treatment received. An AE is defined as any unfavorable and unintended medical occurrence, symptom, or disease witnessed in a participant, regardless of whether or not a causal relationship with the study treatment can be demonstrated. (NCT03351608)
Timeframe: Up to 7 days

InterventionPercentage of Participants (Number)
Part B: Neostigmine + (Glycopyrrolate or Atropine)97.1
Parts A and B: Sugammadex 2 mg78.4
Parts A and B: Sugammadex 4 mg74.9

[back to top]

Maximum Plasma Concentration (Cmax) of Sugammadex [Part A]

The Cmax of sugammadex, defined as the maximum plasma concentration, was determined in each Part A arm. (NCT03351608)
Timeframe: 2 minutes (min), 15 min, 30 min, 60 min, 4-6 hours (hrs), and 10 hrs post-dose

Interventionµg/mL (Geometric Mean)
Part A: Sugammadex 2 mg (2 to <6 Years)17.5
Part A: Sugammadex 2 mg (6 to <12 Years)32.2
Part A: Sugammadex 2 mg (12 to <17 Years)41.3
Part A: Sugammadex 4 mg (2 to <6 Years)47.1
Part A: Sugammadex 4 mg (6 to <12 Years)51.6
Part A: Sugammadex 4 mg (12 to <17 Years)61.9

[back to top]

Area Under the Plasma Concentration-Time Curve (AUC) From Dosing to Infinity (AUC0-∞) of Sugammadex [Part A]

The AUCo-∞ for sugammadex, defined as the area under the plasma concentration versus time plot, was determined in each Part A arm. (NCT03351608)
Timeframe: 2 minutes (min), 15 min, 30 min, 60 min, 4-6 hours (hrs), and 10 hrs post-dose

Interventionhr*μg/mL (Geometric Mean)
Part A: Sugammadex 2 mg (2 to <6 Years)14.1
Part A: Sugammadex 2 mg (6 to <12 Years)18.8
Part A: Sugammadex 2 mg (12 to <17 Years)27.6
Part A: Sugammadex 4 mg (2 to <6 Years)26.9
Part A: Sugammadex 4 mg (6 to <12 Years)38.2
Part A: Sugammadex 4 mg (12 to <17 Years)49.2

[back to top]

Time Until Complete Reversal of Neuromuscular Blockade

Measure how long it takes to return from a TOF of 2 to a TOF ≥ 0.9. (NCT03904550)
Timeframe: In the operating room, the amount of time after administration of the reversal syringe to reach recovery of neuromuscular function (TOFR ≥ 90%) assessed up to 30 minutes.

InterventionMinutes (Mean)
Cisatracurium + Neostigmine14.8
Rocuronium + Sugammadex3.5

[back to top]

Tidal Volume

Tidal volume post-reversal prior to extubation (NCT03939923)
Timeframe: between 30 minutes to 1 hour after extubation

InterventionLiters (Mean)
Neostigmine/Glycopyrrolate1.16
Sugammadex1.0975

[back to top]

Peak Flow Rate

Peak flow rate - measured by peak flow meter post-extubation at 30-60 mins (NCT03939923)
Timeframe: 30-60 minutes post-extubation

InterventionL/min (Mean)
Neostigmine/Glycopyrrolate1.4609
Sugammadex1.416

[back to top]

Blood Pressure (First Measurement of Systolic Blood Pressure Post Reversal)

Blood pressure; measure of systolic blood pressure of subject is obtained post-reversal prior to extubation of trachea (NCT03939923)
Timeframe: 0 minutes to 2 hours after study drug administration

InterventionmmHg (Mean)
Neostigmine/Glycopyrrolate105.6
Sugammadex112.1

[back to top]

Time to Extubation

"Time to extubation: West Virginia University Hospitals use an electronic medical record (EMR) to chart procedure stop. The definition for time to extubation is from the time the investigators chart procedure stop to the time of extubation." (NCT03939923)
Timeframe: 0 minutes of study drug to 3 days after study drug administration

InterventionMinutes (Mean)
Neostigmine/Glycopyrrolate10.4
Sugammadex6

[back to top]

Heart Rate

Heart rate post-reversal prior to extubation (NCT03939923)
Timeframe: 0 minutes to 2 hours after study drug administration

Interventionbeats per minute (Mean)
Neostigmine/Glycopyrrolate81.5385
Sugammadex81.1622

[back to top]

Plasma Concentrations

Plasma concentrations of rocuronium and sugammadex sodium (NCT03943888)
Timeframe: From anesthetic induction to 480 minutes after sugammadex administration

,,
Interventionmcg/mL (Mean)
SugammadexRocuronium
Sugammadex 2mg28.55.3
Sugammadex 4mg58.28.0
Sugammadex 8mg118.95.4

[back to top]

Plasma Concentrations

Plasma concentrations of rocuronium and sugammadex sodium (NCT03943888)
Timeframe: From anesthetic induction to 480 minutes after sugammadex administration

Interventionmcg/mL (Mean)
Rocuronium
Conventional Reversal6.8

[back to top]

Neuromuscular Recovery

Time to recovery of train-of-four T4/T1 ratio to 90% after sugammadex sodium or neuromuscular reversal agent administration up to 30 minutes to 1 hour. (NCT03943888)
Timeframe: up to 30 minutes to 1 hour

InterventionMinutes (Mean)
Sugammadex 2mg5.7
Sugammadex 4mg3.1
Sugammadex 8mg1.1
Conventional Reversal43.7

[back to top]

Incidence of Postoperative Residual Neuromuscular Blockade at Time of Extubation

Train-of-four ratio <0.9 as measured by electromyography or <1.0 measured by acceleromyography (NCT03958201)
Timeframe: Within two minutes of extubation

InterventionParticipants (Count of Participants)
Subjects Undergoing Elective Surgery Involving the Intraoperative Use of Rocuronium0

[back to top]

Incidence of Severe Postoperative Residual Neuromuscular Blockade at Time of Extubation

Train-of-four ratio <0.7 as measured by electromyography (NCT03958201)
Timeframe: Within two minutes of extubation

InterventionParticipants (Count of Participants)
Subjects Undergoing Elective Surgery Involving the Intraoperative Use of Rocuronium0

[back to top]