neostigmine has been researched along with Bradyarrhythmia in 51 studies
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.
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.
| Excerpt | Relevance | Reference |
|---|---|---|
| "To review the literature on the safety and effectiveness of neostigmine for the treatment of postoperative acute colonic pseudo-obstruction." | 8.88 | Intravenous neostigmine for postoperative acute colonic pseudo-obstruction. ( Elsner, JL; Ensor, CR; Smith, JM, 2012) |
| " We report the case of a critically ill patient with ACPO who experienced bradycardia and a brief episode of asystole when receiving concomitant dexmedetomidine and neostigmine infusions but who later remained hemodynamically stable when receiving propofol and neostigmine infusions." | 8.12 | Asystole Following Concomitant Intravenous Administration of Neostigmine and Dexmedetomidine in a Patient With Acute Colonic Pseudo-Obstruction. ( Bell, CM; Parli, SE; Procter, LD, 2022) |
| "To compare clinical response of intermittent bolus versus continuous infusion neostigmine for acute colonic pseudo-obstruction (ACPO)." | 7.96 | 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) |
| "Beginning in September 2016 through initiation of data collection, we identified from our data warehouse that all patients were treated with sugammadex for reversal of neuromuscular blockade, from birth through adolescence, and retrospectively matched, by case type and age group, to historical neostigmine-treated controls." | 7.91 | 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) |
| "Neostigmine is traditionally administered intravenously for treatment of acute colonic pseudo-obstruction (ACPO), though use is associated with administration constraints and adverse effects." | 7.88 | 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) |
| "Neostigmine significantly decreases colonic compliance in patients with refractory chronic constipation." | 7.83 | Evaluating the safety and the effects on colonic compliance of neostigmine during motility testing in patients with chronic constipation. ( Acosta, A; Bharucha, AE; Camilleri, M; Halland, M; Lee, T; Mouchli, MA; Parthasarathy, G; Vijayvargiya, P, 2016) |
| "These observations indicate that neostigmine produces bradycardia following cardiac transplantation, and suggest that a greater response may be observed in remotely than in recently transplanted patients." | 7.69 | Neostigmine-induced bradycardia following recent vs remote cardiac transplantation in the same patient. ( Backman, SB; Fox, GS; Ralley, FE; Stein, RD, 1996) |
| "Neostigmine evoked bradycardia in vagotomized, propranolol-treated cats." | 7.68 | Mechanism of the bradycardia produced in the cat by the anticholinesterase neostigmine. ( Bachoo, M; Backman, SB; Polosa, C, 1993) |
| "Pediatric participants recovered from rocuronium- or vecuronium-induced moderate neuromuscular blockade significantly faster with sugammadex 2 mg/kg than with neostigmine." | 5.51 | Sugammadex for reversal of neuromuscular blockade in pediatric patients: Results from a phase IV randomized study. ( DeAngelis, M; Hammer, GB; Herring, WJ; Saldien, V; Speek, M; Voss, T; Wang, A; Wrishko, R, 2022) |
| "Compared with neostigmine/glycopyrrolate, incidence of TE sinus bradycardia was significantly lower with sugammadex 2 mg/kg and incidence of TE sinus tachycardia was significantly lower with sugammadex 2 mg/kg and 4 mg/kg." | 5.41 | 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) |
| " 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." | 5.31 | Retrospective study of neostigmine for the treatment of acute colonic pseudo-obstruction. ( Abeyta, BJ; Albrecht, RM; Schermer, CR, 2001) |
| "The use of intrathecal neostigmine as an analgesic drug in perianal surgery is unsatisfactory because of prolonged motor blockade and nausea." | 5.10 | Analgesic effects of intrathecal neostigmine in perianal surgery. ( Erman, M; Karsli, B; Yegin, A; Yilmaz, M, 2003) |
| "To review the literature on the safety and effectiveness of neostigmine for the treatment of postoperative acute colonic pseudo-obstruction." | 4.88 | Intravenous neostigmine for postoperative acute colonic pseudo-obstruction. ( Elsner, JL; Ensor, CR; Smith, JM, 2012) |
| "Sugammadex and neostigmine given to reverse residual neuromuscular blockade can cause side effects including bradycardia, anaphylaxis, bronchospasm, and even cardiac arrest." | 4.12 | 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) |
| " We report the case of a critically ill patient with ACPO who experienced bradycardia and a brief episode of asystole when receiving concomitant dexmedetomidine and neostigmine infusions but who later remained hemodynamically stable when receiving propofol and neostigmine infusions." | 4.12 | Asystole Following Concomitant Intravenous Administration of Neostigmine and Dexmedetomidine in a Patient With Acute Colonic Pseudo-Obstruction. ( Bell, CM; Parli, SE; Procter, LD, 2022) |
| "To compare clinical response of intermittent bolus versus continuous infusion neostigmine for acute colonic pseudo-obstruction (ACPO)." | 3.96 | 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) |
| "Neuromuscular blockade reversal with neostigmine and glycopyrrolate was associated with an increased incidence of intraoperative tachycardia and bradycardia but not with 30-day postoperative cardiovascular complications." | 3.96 | Effects of Anticholinesterase Reversal Under General Anesthesia on Postoperative Cardiovascular Complications: A Retrospective Cohort Study. ( Deng, H; Eikermann, M; Forman, SA; Houle, TT; Kelly, BJ; Lihn, AL; Nourmahnad, A; Scheffenbichler, FT; Shaydenfish, D; Xu, X, 2020) |
| "Beginning in September 2016 through initiation of data collection, we identified from our data warehouse that all patients were treated with sugammadex for reversal of neuromuscular blockade, from birth through adolescence, and retrospectively matched, by case type and age group, to historical neostigmine-treated controls." | 3.91 | 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) |
| "Neostigmine is traditionally administered intravenously for treatment of acute colonic pseudo-obstruction (ACPO), though use is associated with administration constraints and adverse effects." | 3.88 | 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) |
| "Neostigmine significantly decreases colonic compliance in patients with refractory chronic constipation." | 3.83 | Evaluating the safety and the effects on colonic compliance of neostigmine during motility testing in patients with chronic constipation. ( Acosta, A; Bharucha, AE; Camilleri, M; Halland, M; Lee, T; Mouchli, MA; Parthasarathy, G; Vijayvargiya, P, 2016) |
| "These observations indicate that neostigmine produces bradycardia following cardiac transplantation, and suggest that a greater response may be observed in remotely than in recently transplanted patients." | 3.69 | Neostigmine-induced bradycardia following recent vs remote cardiac transplantation in the same patient. ( Backman, SB; Fox, GS; Ralley, FE; Stein, RD, 1996) |
| "Neostigmine evoked bradycardia in vagotomized, propranolol-treated cats." | 3.68 | Mechanism of the bradycardia produced in the cat by the anticholinesterase neostigmine. ( Bachoo, M; Backman, SB; Polosa, C, 1993) |
| "Sugammadex-induced bradycardia is common and, in most instances, of minimal clinical consequence." | 3.01 | Clarifying the grey space of sugammadex induced bradycardia. ( Chacin, R; Johnson, KB, 2023) |
| "Fentanyl was continued at the designated rate through the initial postoperative phase." | 2.71 | Effect-site concentration of propofol for recovery of consciousness is virtually independent of fentanyl effect-site concentration. ( Iwakiri, H; Matsukawa, T; Nagata, O; Ozaki, M; Sessler, DI, 2003) |
| "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." | 2.66 | Atropine-neostigmine mixture: a dose-response study. ( Gomaa, M; Naguib, M, 1989) |
| "Here, we report a case of cardiac arrest complicating neostigmine use in a 16-year-old woman with cerebral palsy who was being treated in the intensive care unit after orthopaedic surgery." | 1.37 | Cardiac arrest complicating neostigmine use for bowel opening in a critically ill patient. ( Maher, L; Young, PJ, 2011) |
| " 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." | 1.31 | Retrospective study of neostigmine for the treatment of acute colonic pseudo-obstruction. ( Abeyta, BJ; Albrecht, RM; Schermer, CR, 2001) |
| Timeframe | Studies, this research(%) | All Research% |
|---|---|---|
| pre-1990 | 23 (45.10) | 18.7374 |
| 1990's | 8 (15.69) | 18.2507 |
| 2000's | 6 (11.76) | 29.6817 |
| 2010's | 6 (11.76) | 24.3611 |
| 2020's | 8 (15.69) | 2.80 |
| Authors | Studies |
|---|---|
| Herring, WJ | 2 |
| Mukai, Y | 1 |
| Wang, A | 2 |
| Lutkiewicz, J | 1 |
| Lombard, JF | 1 |
| Lin, L | 1 |
| Watkins, M | 1 |
| Broussard, DM | 1 |
| Blobner, M | 1 |
| Voss, T | 1 |
| DeAngelis, M | 1 |
| Speek, M | 1 |
| Saldien, V | 1 |
| Hammer, GB | 1 |
| Wrishko, R | 1 |
| Ruetzler, K | 1 |
| Li, K | 1 |
| Chhabada, S | 1 |
| Maheshwari, K | 1 |
| Chahar, P | 1 |
| Khanna, S | 1 |
| Schmidt, MT | 1 |
| Yang, D | 1 |
| Turan, A | 1 |
| Sessler, DI | 2 |
| Paredes, S | 1 |
| Torres, VH | 1 |
| Chaves-Cardona, H | 1 |
| Matus, M | 1 |
| Porter, S | 1 |
| Renew, JR | 1 |
| Johnson, KB | 1 |
| Chacin, R | 1 |
| Gaver, RS | 1 |
| Brenn, BR | 1 |
| Gartley, A | 1 |
| Donahue, BS | 1 |
| Bell, CM | 1 |
| Procter, LD | 1 |
| Parli, SE | 1 |
| Kram, B | 1 |
| Greenland, M | 1 |
| Grant, M | 1 |
| Campbell, ME | 1 |
| Wells, C | 1 |
| Sommer, C | 1 |
| Smedley, LW | 1 |
| Foster, DB | 1 |
| Barthol, CA | 1 |
| Hall, R | 1 |
| Gutierrez, GC | 1 |
| Shaydenfish, D | 1 |
| Scheffenbichler, FT | 1 |
| Kelly, BJ | 1 |
| Lihn, AL | 1 |
| Deng, H | 1 |
| Nourmahnad, A | 1 |
| Xu, X | 1 |
| Houle, TT | 1 |
| Eikermann, M | 1 |
| Forman, SA | 1 |
| Mouchli, MA | 1 |
| Camilleri, M | 1 |
| Lee, T | 1 |
| Parthasarathy, G | 1 |
| Vijayvargiya, P | 1 |
| Halland, M | 1 |
| Acosta, A | 1 |
| Bharucha, AE | 1 |
| Dodds, MM | 1 |
| Frazer, CD | 1 |
| Lipman, J | 1 |
| Reade, M | 1 |
| Beccaria, P | 1 |
| Cabrini, L | 1 |
| Garancini, MP | 1 |
| Colombo, S | 1 |
| Maher, L | 1 |
| Young, PJ | 1 |
| Elsner, JL | 1 |
| Smith, JM | 1 |
| Ensor, CR | 1 |
| Iwakiri, H | 1 |
| Nagata, O | 1 |
| Matsukawa, T | 1 |
| Ozaki, M | 1 |
| Yegin, A | 1 |
| Yilmaz, M | 1 |
| Karsli, B | 1 |
| Erman, M | 1 |
| GOTTLIEB, JD | 1 |
| SWEET, RB | 1 |
| STOJANOV, EA | 1 |
| Nymark, M | 1 |
| Rasmussen, J | 1 |
| Yan, HC | 1 |
| Seidl, DC | 1 |
| Martin, DE | 1 |
| Long, G | 1 |
| Marsh, HM | 1 |
| Backman, SB | 4 |
| Ralley, FE | 3 |
| Fox, GS | 3 |
| Bachoo, M | 1 |
| Polosa, C | 1 |
| Stein, RD | 1 |
| Fuchs-Buder, T | 1 |
| Ziegenfuss, T | 1 |
| Lysakowski, K | 1 |
| Tassonyi, E | 1 |
| Abbasakoor, F | 1 |
| Evans, A | 1 |
| Stephenson, BM | 1 |
| Vavilala, MS | 1 |
| Lam, AM | 1 |
| Chang, Y | 1 |
| Hoover, DB | 1 |
| Hancock, JC | 1 |
| Mullins, ME | 1 |
| Dribben, W | 1 |
| Abeyta, BJ | 1 |
| Albrecht, RM | 1 |
| Schermer, CR | 1 |
| Chiche, P | 1 |
| Lellouch, A | 1 |
| Denizeau, JP | 1 |
| Sprague, DH | 1 |
| Oduro, KA | 1 |
| Haruta, K | 1 |
| Iguchi, A | 1 |
| Matsubara, T | 1 |
| Itoh, K | 1 |
| Chen, CL | 1 |
| Yoshida, S | 1 |
| Terada, R | 1 |
| Kanashiro, M | 1 |
| Suzuki, O | 1 |
| Nishimura, H | 1 |
| Naguib, M | 1 |
| Gomaa, M | 1 |
| Eldor, J | 1 |
| Hoffman, B | 1 |
| Davidson, JT | 1 |
| Lowe, PA | 1 |
| Triantafillou, AN | 1 |
| Tsueda, K | 1 |
| Berg, J | 1 |
| Wieman, TJ | 1 |
| Robinson, SJ | 1 |
| Dighton, DH | 1 |
| Gray, GW | 1 |
| Marriott, HJ | 1 |
| Ramamurthy, S | 1 |
| Shaker, MH | 1 |
| Winnie, AP | 1 |
| Gravenstein, JS | 1 |
| Suga, F | 1 |
| Snow, JB | 1 |
| Varma, DR | 1 |
| Fekete, M | 1 |
| Tipton, CM | 1 |
| Barnard, RJ | 1 |
| Tharp, GD | 1 |
| Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
|---|---|---|---|---|---|---|---|
| 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 4 | 344 participants (Actual) | Interventional | 2017-12-20 | Completed | ||
| 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 4 | 288 participants (Actual) | Interventional | 2018-02-12 | Completed | ||
| Evaluating the Safety and Efficacy of Different Routes of Neostigmine Administration for Acute Colonic Pseudo Obstruction: a Prospective Randomized Trial[NCT04951726] | Phase 4 | 90 participants (Anticipated) | Interventional | 2022-02-04 | Recruiting | ||
| [information is prepared from clinicaltrials.gov, extracted Sep-2024] | |||||||
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
| Intervention | Percentage of Participants (Number) |
|---|---|
| Sugammadex 2 mg/kg | 11.4 |
| Sugammadex 4 mg/kg | 7.5 |
| Sugammadex 16 mg/kg | 10.3 |
| Neostigmine + Glycopyrrolate | 5.9 |
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
| Intervention | Percentage of participants (Number) |
|---|---|
| Sugammadex 2 mg/kg | 94.3 |
| Sugammadex 4 mg/kg | 88.8 |
| Sugammadex 16 mg/kg | 92.6 |
| Neostigmine + Glycopyrrolate | 88.2 |
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
| Intervention | Percentage of participants (Number) |
|---|---|
| Sugammadex 2 mg/kg | 1.0 |
| Sugammadex 4 mg/kg | 0.0 |
| Sugammadex 16 mg/kg | 1.5 |
| Neostigmine + Glycopyrrolate | 2.0 |
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
| Intervention | Percentage of participants (Number) |
|---|---|
| Sugammadex 2 mg/kg | 1.0 |
| Sugammadex 4 mg/kg | 1.9 |
| Sugammadex 16 mg/kg | 7.4 |
| Neostigmine + Glycopyrrolate | 7.8 |
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
| Intervention | Percentage of participants (Number) |
|---|---|
| Sugammadex 2 mg/kg | 6.7 |
| Sugammadex 4 mg/kg | 9.3 |
| Sugammadex 16 mg/kg | 8.8 |
| Neostigmine + Glycopyrrolate | 21.6 |
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
| Intervention | Percentage of Participants (Number) | ||||||
|---|---|---|---|---|---|---|---|
| With one or more ECIs | Adjudicated Hypersensitivity | Adjudicated Anaphylaxis | Clinically Relevant Bradycardia | Clinically Relevant Tachycardia | Other Clinically Relevant Cardiac Arrhythmia | Drug Induced Liver Injury | |
| Neostigmine + Glycopyrrolate | 3.9 | 0.0 | 0.0 | 2.0 | 0.0 | 2.0 | 0.0 |
| Sugammadex 16 mg/kg | 7.4 | 0.0 | 0.0 | 0.0 | 5.9 | 1.5 | 0.0 |
| Sugammadex 2 mg/kg | 1.9 | 0.0 | 0.0 | 0.0 | 1.9 | 0.0 | 0.0 |
| Sugammadex 4 mg/kg | 5.6 | 0.0 | 0.0 | 2.8 | 1.9 | 0.9 | 0.0 |
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
| Intervention | Liters (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 |
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
| Intervention | hr*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 |
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
| Intervention | µg/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 |
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
| Intervention | Percentage of Participants (Number) |
|---|---|
| Part B: Neostigmine + (Glycopyrrolate or Atropine) | 97.1 |
| Parts A and B: Sugammadex 2 mg | 78.4 |
| Parts A and B: Sugammadex 4 mg | 74.9 |
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
| Intervention | L/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 |
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
| Intervention | Hours (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 |
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
| Intervention | Minutes (Geometric Mean) |
|---|---|
| Part B: Sugammadex 2 mg/kg | 1.1 |
| Part B: Sugammadex 4 mg/kg | 1.3 |
| Part B: Neostigmine + (Glycopyrrolate or Atropine) | 3.7 |
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
| Intervention | Minutes (Geometric Mean) |
|---|---|
| Part B: Sugammadex 2 mg/kg | 1.3 |
| Part B: Sugammadex 4 mg/kg | 1.5 |
| Part B: Neostigmine + (Glycopyrrolate or Atropine) | 5.0 |
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
| Intervention | Minutes (Geometric Mean) |
|---|---|
| Part B: Sugammadex 2 mg/kg | 1.6 |
| Part B: Sugammadex 4 mg/kg | 1.9 |
| Part B: Neostigmine + (Glycopyrrolate or Atropine) | 7.5 |
4 reviews available for neostigmine and Bradyarrhythmia
| Article | Year |
|---|---|
Clarifying the grey space of sugammadex induced bradycardia.
Topics: Bradycardia; Humans; Neostigmine; Neuromuscular Blockade; Retrospective Studies; Sugammadex | 2023 |
Intravenous neostigmine for postoperative acute colonic pseudo-obstruction.
Topics: Bradycardia; Cholinesterase Inhibitors; Colonic Pseudo-Obstruction; Humans; Infusions, Intravenous; | 2012 |
Treatment of cardiac arrhythmias.
Topics: Adams-Stokes Syndrome; Arrhythmia, Sinus; Arrhythmias, Cardiac; Atrial Fibrillation; Atrial Flutter; | 1964 |
Management of cardiac dysrhythmias complicating acute myocardial infarction.
Topics: Arrhythmias, Cardiac; Atrial Fibrillation; Atrial Flutter; Atropine; Bradycardia; Bretylium Compound | 1968 |
7 trials available for neostigmine and Bradyarrhythmia
| Article | Year |
|---|---|
A randomized trial evaluating the safety profile of sugammadex in high surgical risk ASA physical class 3 or 4 participants.
Topics: Aged; Bradycardia; Cholinergic Agents; Double-Blind Method; Female; Glycopyrrolate; Humans; Male; Ne | 2021 |
Sugammadex for reversal of neuromuscular blockade in pediatric patients: Results from a phase IV randomized study.
Topics: Anaphylaxis; Anesthetics; Bradycardia; Child; Humans; Neostigmine; Neuromuscular Blockade; Neuromusc | 2022 |
Effect-site concentration of propofol for recovery of consciousness is virtually independent of fentanyl effect-site concentration.
Topics: Adult; Anesthesia Recovery Period; Anesthetics, Intravenous; Atropine; Bradycardia; Female; Fentanyl | 2003 |
Analgesic effects of intrathecal neostigmine in perianal surgery.
Topics: Anal Canal; Anesthesia, Local; Anesthetics, Combined; Anesthetics, Local; Bradycardia; Bupivacaine; | 2003 |
Antagonism of vecuronium-induced neuromuscular block in patients pretreated with magnesium sulphate: dose-effect relationship of neostigmine.
Topics: Adult; Anti-Arrhythmia Agents; Anticonvulsants; Bradycardia; Cholinesterase Inhibitors; Dose-Respons | 1999 |
Glycopyrrolate methobromide: 2. comparison with atropine sulphate in anaesthesia.
Topics: Adolescent; Adult; Aged; Atropine; Blood Pressure; Bradycardia; Female; Glycopyrrolate; Humans; Inje | 1975 |
Atropine-neostigmine mixture: a dose-response study.
Topics: Adult; Anesthesia, Inhalation; Atropine; Bradycardia; Dose-Response Relationship, Drug; Female; Hear | 1989 |
40 other studies available for neostigmine and Bradyarrhythmia
| Article | Year |
|---|---|
Sugammadex Versus Neostigmine for Reversal of Residual Neuromuscular Blocks After Surgery: A Retrospective Cohort Analysis of Postoperative Side Effects.
Topics: Anaphylaxis; Bradycardia; Bronchial Spasm; Child; Cohort Studies; Delayed Emergence from Anesthesia; | 2022 |
An appraisal of neostigmine versus sugammadex for neuromuscular blockade reversal in patients with a prior heart transplant.
Topics: Anesthetics; Bradycardia; Heart Transplantation; Humans; Hypotension; Neostigmine; Neuromuscular Blo | 2023 |
Retrospective Analysis of the Safety and Efficacy of Sugammadex Versus Neostigmine for the Reversal of Neuromuscular Blockade in Children.
Topics: Adolescent; Age Factors; Anesthesia Recovery Period; Bradycardia; Child; Child, Preschool; Cholinest | 2019 |
Asystole Following Concomitant Intravenous Administration of Neostigmine and Dexmedetomidine in a Patient With Acute Colonic Pseudo-Obstruction.
Topics: Acute Disease; Bradycardia; Colonic Pseudo-Obstruction; Dexmedetomidine; Heart Arrest; Humans; Infus | 2022 |
Efficacy and Safety of Subcutaneous Neostigmine for Ileus, Acute Colonic Pseudo-obstruction, or Refractory Constipation.
Topics: Acute Disease; Adult; Aged; Bradycardia; Cholinesterase Inhibitors; Colonic Pseudo-Obstruction; Cons | 2018 |
Safety and Efficacy of Intermittent Bolus and Continuous Infusion Neostigmine for Acute Colonic Pseudo-Obstruction.
Topics: Acute Disease; Adult; Aged; Bradycardia; Cholinesterase Inhibitors; Colonic Pseudo-Obstruction; Defe | 2020 |
Effects of Anticholinesterase Reversal Under General Anesthesia on Postoperative Cardiovascular Complications: A Retrospective Cohort Study.
Topics: Adult; Aged; Anesthesia, General; Boston; Bradycardia; Cholinesterase Inhibitors; Female; Glycopyrro | 2020 |
Evaluating the safety and the effects on colonic compliance of neostigmine during motility testing in patients with chronic constipation.
Topics: Adult; Bradycardia; Cholinesterase Inhibitors; Chronic Disease; Colon; Constipation; Female; Gastroi | 2016 |
Use of neostigmine for acute colonic pseudo-obstruction in a patient receiving dexmedetomidine.
Topics: Acute Disease; Analgesics, Non-Narcotic; Bradycardia; Cholinesterase Inhibitors; Colonic Pseudo-Obst | 2016 |
Recurarisation in a surgical ward.
Topics: Acetaminophen; Aged; Analgesics, Non-Narcotic; Anesthesia Recovery Period; Anesthesia, General; Anes | 2008 |
Cardiac arrest complicating neostigmine use for bowel opening in a critically ill patient.
Topics: Adolescent; Bradycardia; Cholinesterase Inhibitors; Colonic Pseudo-Obstruction; Critical Illness; Fe | 2011 |
The antagonism of curare: the cardiac effects of atropine and neostigmine.
Topics: Arrhythmias, Cardiac; Atropine; Bradycardia; Curare; Heart; Humans; Neostigmine | 1963 |
[GALANTHAMINUM HYDROBROMICUM ("NIVALINE"), A NEW ANTIDOTE OF NON-POLARIZING MUSCLE RELAXANTS. PHARMACOLOGY AND CLINICAL USE].
Topics: Anesthesia; Anesthesiology; Animals; Antidotes; Atropine; Biomedical Research; Bradycardia; Cats; Ga | 1964 |
Effect of certain drugs upon amitriptyline induced electrocardiographic changes.
Topics: Acetylcholine; Amitriptyline; Animals; Atropine; Blood Pressure; Bradycardia; Bundle-Branch Block; E | 1966 |
The provocative test and their diagnostic value in sinus node failure.
Topics: Adult; Atropine; Bradycardia; Electrocardiography; Female; Heart Rate; Humans; Isoproterenol; Male; | 1984 |
Prolonged bradycardia after neostigmine administration in a patient taking nadolol.
Topics: Anesthesia, General; Bradycardia; Drug Interactions; Female; Humans; Hypertension; Middle Aged; Nado | 1984 |
The effect on heart rate of neuromuscular blockade reversal by pyridostigmine.
Topics: Adolescent; Adult; Atropine; Bradycardia; Female; Heart Rate; Humans; Middle Aged; Neostigmine; Neur | 1981 |
Anaesthesia for cardiac transplant patients.
Topics: Anesthesia; Animals; Bradycardia; Cats; Cholinesterase Inhibitors; Heart Rate; Heart Transplantation | 1994 |
Neostigmine produces bradycardia in a heart transplant patient.
Topics: Atropine; Bradycardia; Heart Transplantation; Humans; Male; Middle Aged; Neostigmine | 1993 |
Mechanism of the bradycardia produced in the cat by the anticholinesterase neostigmine.
Topics: Acetylcholine; Animals; Bradycardia; Cats; Edrophonium; Heart Rate; Neostigmine; Parasympathetic Ner | 1993 |
Neostigmine-induced bradycardia following recent vs remote cardiac transplantation in the same patient.
Topics: Bradycardia; Cholinesterase Inhibitors; Heart Transplantation; Humans; Male; Middle Aged; Neostigmin | 1996 |
Neostigmine for acute colonic pseudo-obstruction.
Topics: Acute Disease; Bradycardia; Colonic Pseudo-Obstruction; Contrast Media; Diagnostic Errors; Enema; Gl | 1999 |
Neostigmine for acute colonic pseudo-obstruction.
Topics: Acute Disease; Bradycardia; Cholinesterase Inhibitors; Colonic Pseudo-Obstruction; Glycopyrrolate; H | 1999 |
Endogenous tachykinins cause bradycardia by stimulating cholinergic neurons in the isolated guinea pig heart.
Topics: Acetylcholine; Animals; Atropine; Bradycardia; Calcitonin Gene-Related Peptide; Capsaicin; Cholinerg | 2000 |
Physostigmine treatment of gamma-hydroxybutyric acid overdose: appropriate or inappropriate use of a reversal agent?
Topics: Anesthetics; Bradycardia; Cholinesterase Inhibitors; Drug Overdose; Humans; Hydroxybutyrates; Neosti | 2000 |
Retrospective study of neostigmine for the treatment of acute colonic pseudo-obstruction.
Topics: Acute Disease; Aged; Aged, 80 and over; Algorithms; Bradycardia; Colonic Pseudo-Obstruction; Contrai | 2001 |
Autonomic influences and cardiac conduction in patients with sinus node disease.
Topics: Adult; Aged; Ajmaline; Arrhythmia, Sinus; Atropine; Blood Pressure; Bradycardia; Bundle of His; Digi | 1976 |
Severe bradycardia after neostigmine in a patient taking propranolol to control paroxysmal atrial tachycardia.
Topics: Bradycardia; Heart; Humans; Injections, Intravenous; Male; Middle Aged; Neostigmine; Propranolol; Ta | 1975 |
Stimulation of muscarinic cholinoceptive neurons in the hippocampus evokes a pressor response with bradycardia.
Topics: Animals; Atropine Derivatives; Blood Pressure; Bradycardia; Epinephrine; Heart Rate; Hippocampus; Ki | 1992 |
Prolonged bradycardia and hypotension after neostigmine administration in a patient receiving atenolol.
Topics: Aged; Atenolol; Bradycardia; Drug Interactions; Female; Humans; Hypotension; Neostigmine; Pancuroniu | 1987 |
Verapamil-neostigmine interaction?
Topics: Bradycardia; Drug Interactions; Female; Humans; Intraoperative Complications; Middle Aged; Neostigmi | 1986 |
Refractory bradycardia after reversal of muscle relaxant in a diabetic with vagal neuropathy.
Topics: Autonomic Nervous System Diseases; Blood Pressure; Bradycardia; Diabetic Neuropathies; Glycopyrrolat | 1986 |
Sinus bradycardia. Autonomic influences and clinical assessment.
Topics: Adams-Stokes Syndrome; Adolescent; Adult; Aged; Atropine; Autonomic Nervous System; Bradycardia; Dip | 1974 |
Acute experiments on neuroeffector function in canine esophageal achalasia.
Topics: Acetylcholine; Animals; Atropine; Blood Pressure; Bradycardia; Deglutition; Dog Diseases; Dogs; Elec | 1974 |
Glycopyrrolate as a substitute for atropine in neostigmine reversal of muscle relaxant drugs.
Topics: Anesthesia; Atropine; Bradycardia; Curare; Drug Combinations; Female; Glycopyrrolate; Heart Rate; Hu | 1972 |
The belladonna drugs.
Topics: Anesthesia; Atropa belladonna; Atropine; Blood Pressure; Bradycardia; Cardiac Output; Central Nervou | 1968 |
Cholinergic control of cochlear blood flow.
Topics: Acetylcholine; Animals; Atropine; Bethanechol Compounds; Blood Pressure; Bradycardia; Cochlea; Edrop | 1969 |
Cholinergic transmission in the cat medulla oblongata in the initiation of vagal bradycardia.
Topics: Animals; Atropine; Blood Pressure; Bradycardia; Cats; Electric Stimulation; Female; Hexamethonium Co | 1966 |
A possible role of cholinergic effects in the noradrenaline potentiating action of imipramine.
Topics: Animals; Arrhythmias, Cardiac; Bradycardia; Cats; Dogs; Electrocardiography; Female; Hexamethonium C | 1966 |
Cholinesterase activity in trained and nontrained rats.
Topics: Acetylcholine; Animals; Atropine; Body Weight; Bradycardia; Butyrates; Cholinesterases; Conditioning | 1966 |