Page last updated: 2024-10-31

neostigmine and Anaphylaxis

neostigmine has been researched along with Anaphylaxis in 17 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.

Anaphylaxis: An acute hypersensitivity reaction due to exposure to a previously encountered ANTIGEN. The reaction may include rapidly progressing URTICARIA, respiratory distress, vascular collapse, systemic SHOCK, and death.

Research Excerpts

ExcerptRelevanceReference
"This was a retrospective multicentre observational study of patients who underwent surgery under general anaesthesia between 2012 and 2016 to compare the incidence of anaphylaxis with sugammadex with that of neostigmine at four tertiary hospitals in Japan."7.96Comparison of incidence of anaphylaxis between sugammadex and neostigmine: a retrospective multicentre observational study. ( Horiuchi, T; Nagumo, K; Orihara, M; Saito, S; Sakamoto, S; Takazawa, T; Tomioka, A; Tomita, Y; Yokohama, A; Yoshida, N, 2020)
"A patient developed anaphylaxis during anaesthesia, towards the end of surgery, 30 s after intravenous administration of neostigmine."7.70Anaphylaxis caused by neostigmine. ( Ewan, PW; Seed, MJ, 2000)
" Participants aged 2 to <17 years, under moderate or deep neuromuscular blockade, were administered sugammadex (2 or 4 mg/kg) or neostigmine (50 µg/kg; for moderate neuromuscular blockade only)."5.51Sugammadex 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)
"Sugammadex and neostigmine given to reverse residual neuromuscular blockade can cause side effects including bradycardia, anaphylaxis, bronchospasm, and even cardiac arrest."4.12Sugammadex 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)
"This was a retrospective multicentre observational study of patients who underwent surgery under general anaesthesia between 2012 and 2016 to compare the incidence of anaphylaxis with sugammadex with that of neostigmine at four tertiary hospitals in Japan."3.96Comparison of incidence of anaphylaxis between sugammadex and neostigmine: a retrospective multicentre observational study. ( Horiuchi, T; Nagumo, K; Orihara, M; Saito, S; Sakamoto, S; Takazawa, T; Tomioka, A; Tomita, Y; Yokohama, A; Yoshida, N, 2020)
" The automated MedDRA query method showed no apparent increase in hypersensitivity or anaphylaxis with sugammadex as compared to placebo or neostigmine."3.88Incidence of hypersensitivity and anaphylaxis with sugammadex. ( Adkinson, F; Assaid, C; Gurner, DM; Herring, WJ; McCrea, J; Min, KC; Sisk, CM; Woo, T, 2018)
" Immunized BP2 mice developed an acute bronchoconstriction in vivo and airway muscle contraction in vitro in response to ovalbumin (OA) and these contractions were dose dependent."3.70Anaphylactic bronchoconstriction in BP2 mice: interactions between serotonin and acetylcholine. ( Brink, C; Eum, SY; Labat, C; Lefort, J; Norel, X; Vargaftig, BB, 1999)
"A patient developed anaphylaxis during anaesthesia, towards the end of surgery, 30 s after intravenous administration of neostigmine."3.70Anaphylaxis caused by neostigmine. ( Ewan, PW; Seed, MJ, 2000)
"Anaphylactoid reaction is a rapid systemic allergic reaction to many kinds of allergen."1.43[Anaphylactoid Reactions Suspected to Be Caused by Neostigmine in Pediatric Patients under General Anesthesia]. ( Arai, M; Asagoe, Y; Iwasai, S; Kinoshita, Y; Matsuzaki, T; Sato, T, 2016)

Research

Studies (17)

TimeframeStudies, this research(%)All Research%
pre-19903 (17.65)18.7374
1990's1 (5.88)18.2507
2000's4 (23.53)29.6817
2010's3 (17.65)24.3611
2020's6 (35.29)2.80

Authors

AuthorsStudies
Voss, T1
Wang, A1
DeAngelis, M1
Speek, M1
Saldien, V1
Hammer, GB1
Wrishko, R1
Herring, WJ2
Ruetzler, K1
Li, K1
Chhabada, S1
Maheshwari, K1
Chahar, P1
Khanna, S1
Schmidt, MT1
Yang, D1
Turan, A1
Sessler, DI1
Orihara, M1
Takazawa, T1
Horiuchi, T1
Sakamoto, S1
Nagumo, K1
Tomita, Y1
Tomioka, A1
Yoshida, N1
Yokohama, A1
Saito, S1
McKenzie, AJ1
Banik, RK1
Karuppiah, S1
Kaizer, AM1
de Boer, HD1
Hunter, JM1
Min, KC1
Woo, T1
Assaid, C1
McCrea, J1
Gurner, DM1
Sisk, CM1
Adkinson, F1
Hermite, L1
Louvier, N1
Hilaire, P1
Orry, D1
Seltzer, S1
Collet, E1
Iwasai, S1
Kinoshita, Y1
Asagoe, Y1
Matsuzaki, T1
Arai, M1
Sato, T1
RITTWAGEN, M1
ROMANO, FJ1
SVIGALS, MP1
Coelho, D1
Fernandes, T1
Branga, P1
Malheiro, D1
Rodrigues, J1
Nezhinskaya, GI1
Vladykin, AL1
Sapronov, NS1
Eum, SY1
Norel, X1
Lefort, J1
Labat, C1
Vargaftig, BB1
Brink, C1
Seed, MJ1
Ewan, PW1
McNicholas, JJ1
Harban, FM1
Lysenkov, SP1
Proskuriakov, IA1
Rosenthale, ME1
Dervinis, A1
Kassarich, J1

Clinical Trials (1)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
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
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

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

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

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

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

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

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

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

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

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

Trials

1 trial available for neostigmine and Anaphylaxis

ArticleYear
Sugammadex for reversal of neuromuscular blockade in pediatric patients: Results from a phase IV randomized study.
    Paediatric anaesthesia, 2022, Volume: 32, Issue:3

    Topics: Anaphylaxis; Anesthetics; Bradycardia; Child; Humans; Neostigmine; Neuromuscular Blockade; Neuromusc

2022

Other Studies

16 other studies available for neostigmine and Anaphylaxis

ArticleYear
Sugammadex Versus Neostigmine for Reversal of Residual Neuromuscular Blocks After Surgery: A Retrospective Cohort Analysis of Postoperative Side Effects.
    Anesthesia and analgesia, 2022, 05-01, Volume: 134, Issue:5

    Topics: Anaphylaxis; Bradycardia; Bronchial Spasm; Child; Cohort Studies; Delayed Emergence from Anesthesia;

2022
Comparison of incidence of anaphylaxis between sugammadex and neostigmine: a retrospective multicentre observational study.
    British journal of anaesthesia, 2020, Volume: 124, Issue:2

    Topics: Adolescent; Adult; Aged; Anaphylaxis; Cholinesterase Inhibitors; Female; Humans; Incidence; Japan; M

2020
Neostigmine anaphlaxis: A rare and missed diagnosis.
    Anaesthesia and intensive care, 2020, Volume: 48, Issue:1

    Topics: Anaphylaxis; Cholinesterase Inhibitors; Humans; Missed Diagnosis; Neostigmine

2020
Statistical significance versus clinical relevance. Comment on Br J Anaesth 2020; 124: 154-63.
    British journal of anaesthesia, 2020, Volume: 124, Issue:6

    Topics: Anaphylaxis; Humans; Incidence; Neostigmine; Retrospective Studies; Sugammadex

2020
Sugammadex or neostigmine: should potential anaphylaxis be the overriding factor in the choice of a reversal drug? Comment on Br J Anaesth 2020; 124: 154-63.
    British journal of anaesthesia, 2020, Volume: 125, Issue:2

    Topics: Anaphylaxis; Humans; Incidence; Neostigmine; Neuromuscular Blockade; Retrospective Studies; Sugammad

2020
Incidence of hypersensitivity and anaphylaxis with sugammadex.
    Journal of clinical anesthesia, 2018, Volume: 47

    Topics: Adult; Aged; Anaphylaxis; Anesthesia Recovery Period; Anesthesia, General; Cholinesterase Inhibitors

2018
Neostigmine induced anaphylaxis in the wake of surgery.
    Anaesthesia, critical care & pain medicine, 2015, Volume: 34, Issue:2

    Topics: Aged; Anaphylaxis; Cholinesterase Inhibitors; Female; Humans; Neostigmine; Postoperative Complicatio

2015
[Anaphylactoid Reactions Suspected to Be Caused by Neostigmine in Pediatric Patients under General Anesthesia].
    Masui. The Japanese journal of anesthesiology, 2016, Volume: 65, Issue:4

    Topics: Anaphylaxis; Anesthesia, General; Female; Humans; Infant; Male; Neostigmine

2016
A study on the incidence of allergy in children with rheumatic fever.
    Archives of pediatrics, 1946, Volume: 63, Issue:12

    Topics: Anaphylaxis; Child; Hypersensitivity; Immune System Diseases; Incidence; Infant; Neostigmine; Rheuma

1946
Intraoperative anaphylaxis after intravenous atropine.
    European journal of anaesthesiology, 2007, Volume: 24, Issue:3

    Topics: Adjuvants, Anesthesia; Aged; Anaphylaxis; Anesthesia, General; Anti-Inflammatory Agents; Atropine; B

2007
Cholinergic modulation of anaphylactic shock: plasma proteins influence.
    Life sciences, 2007, May-30, Volume: 80, Issue:24-25

    Topics: Anaphylaxis; Animals; Blood Proteins; C-Reactive Protein; Cholinergic Agents; Cholinesterase Inhibit

2007
Anaphylactic bronchoconstriction in BP2 mice: interactions between serotonin and acetylcholine.
    British journal of pharmacology, 1999, Volume: 126, Issue:1

    Topics: Acetylcholine; Anaphylaxis; Animals; Atropine; Bronchoconstriction; Bronchodilator Agents; Cholinest

1999
Anaphylaxis caused by neostigmine.
    Anaesthesia, 2000, Volume: 55, Issue:6

    Topics: Anaphylaxis; Cholinesterase Inhibitors; Female; Humans; Intraoperative Complications; Middle Aged; N

2000
Anaphylaxis caused by neostigmine.
    Anaesthesia, 2000, Volume: 55, Issue:10

    Topics: Anaphylaxis; Cholinesterase Inhibitors; Edrophonium; Humans; Neostigmine; Neuromuscular Blockade

2000
[Allergic shock caused by trimecaine in prolonged peridural blockade].
    Vestnik khirurgii imeni I. I. Grekova, 1978, Volume: 120, Issue:5

    Topics: Acetanilides; Adolescent; Anaphylaxis; Anesthesia, Epidural; Female; Humans; Neostigmine; Time Facto

1978
Bronchodilator activity of the prostaglandins E 1 and E 2 .
    The Journal of pharmacology and experimental therapeutics, 1971, Volume: 178, Issue:3

    Topics: Aerosols; Airway Resistance; Anaphylaxis; Animals; Blood Pressure; Bronchodilator Agents; Cats; Cycl

1971