drugset / Trial / NCT05053594

Different Doses of Neostigmine for Reversal of Moderate Neuromuscular Blockade in Children

NCT05053594

Phase 4 Unknown 60 enrolled Pontifical Catholic University of São Paulo
RandomizedParallel-groupTriple-blindTreatment

Summary

There is no recent information on the required dose of neostigmine for the reversal of cisatracurium-induced moderate neuromuscular blockade (NMB) \[Train-of-four (TOF) count = 1-3)\] in children. The aim of this study will be to evaluate by means of a prospective, randomized and double-blinded clinical trial, the time required for reversal of moderate NMB (TOFc 3) to T4/T1 (TOF ratio, TOFr) \> 0.9 and TOFr = 1.0 after administration of different doses of neostigmine (10, 20 or 30 mcg/kg) or placebo in children undergoing inhalational (sevoflurane) general anesthesia. In addition, the probability of NMB reversal in less than 10 minutes, the presence of bradycardia, respiratory complications and postoperative vomiting will be evaluated. The time for reversal is expected to be inversely proportional to the administered dose of neostigmine.

Timeline

Start
2021-10-01
Primary completion
2022-02-01
Completion
2022-02-20

Drugs

EvaluationDrugModalityDoseRoute
Subject Neostigmine Other / unclassified 10 ug/kg
Subject Neostigmine Other / unclassified 20 ug/kg
Subject Neostigmine Other / unclassified 30 ug/kg