drugset / Trial / NCT03229486

Effect of Sugammadex vs. Neostigmine/Glycopyrrolate on Pediatric Emergence Delirium in Sevoflurane-rocuronium Anesthesia

NCT03229486

Phase 4 Completed 40 enrolled Pusan National University Yangsan Hospital
RandomizedParallel-groupTriple-blindPrevention

Summary

The aim of this study is to investigate the effect of sugammadex vs. a conventional acetylcholinesterase inhibitor, neostigmine on emergence delirium (ED) during sevoflurane-rocuronium anesthesia in pediatric patients Additionally, the efficacy features of sugammadex compared to neostigmine will be examined by measuring the time from start of administration of reversal agents to recovery of train-of-four (TOF) ratio to 0.7, 0.8, and 0.9. Although the etiology of ED remains unclear, a sense of suffocation or breathing difficulty during emergence from anesthesia has been suggested as a possible cause. Thus, reversal of neuromuscular blockade with sugammadex in pediatric patients maintained with sevoflurane-rocuronium anesthesia may decrease ED due to its faster reversal of neuromuscular blockade and decreased possibility of residual blockade.

Timeline

Start
2017-03-01
Primary completion
2019-07-30
Completion
2019-12-30

Drugs

EvaluationDrugModalityDoseRoute
Comparator Neostigmine Other / unclassified 0.06 mg/kg Intravenous
Subject Sugammadex Other / unclassified 2 mg/kg Intravenous
Comparator Glycopyrronium Unknown 0.005 mg/kg Intravenous

Indications