Efficacy, Safety, and Pharmacokinetics of Sugammadex for Reversal of Neuromuscular Blockade (NMB) in Pediatric Participants (MK-8616-089)

Phase 4 Completed 288 enrolled Merck Sharp & Dohme LLC

RandomizedParallel-groupTriple-blindTreatment

Summary

This trial will evaluate the efficacy, safety, and pharmacokinetics of sugammadex for the reversal of both moderate and deep neuromuscular blockade (NMB) induced by either rocuronium or vecuronium in pediatric participants. The primary efficacy hypothesis of this investigation is that sugammadex is superior to neostigmine in reversing moderate NMB in pediatric participants as measured by time to recovery to a train-of-four (TOF) ratio of ≥0.9.

Timeline

Start: 2018-02-12
Primary completion: 2020-01-28
Completion: 2020-01-28

Publications

Voss T, Wang A, DeAngelis M, Speek M, Saldien V, Hammer GB, Wrishko R, Herring WJ. Sugammadex for reversal of neuromuscular blockade in pediatric patients: Results from a phase IV randomized study. Paediatr Anaesth. 2022 Mar;32(3):436-445. doi: 10.1111/pan.14370. Epub 2021 Dec 17.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Atropine	Other / unclassified	20 ug/kg	Intravenous
Comparator	Glycopyrrolate	Small molecule	10 ug/kg	Intravenous
Comparator	Neostigmine	Other / unclassified	50 ug/kg	Intravenous
Subject	Sugammadex	Other / unclassified	2 mg/kg	Intravenous
Subject	Sugammadex	Other / unclassified	4 mg/kg	Intravenous

Indications

No indication recorded.