Efficacy, Safety, and Pharmacokinetics of Sugammadex (MK-8616) for Reversal of Neuromuscular Blockade in Pediatric Participants Aged Birth to <2 Years (MK-8616-169)

Phase 4 Completed 145 enrolled Merck Sharp & Dohme LLC

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study will evaluate the efficacy, safety, and pharmacokinetics (PK) of sugammadex (MK-8616) for reversal of both moderate and deep neuromuscular blockade (NMB) in pediatric participants aged birth to \<2 years. The primary hypothesis of this study is that sugammadex is superior to neostigmine in reversing moderate NMB as measured by time to neuromuscular recovery.

Timeline

Start: 2019-07-23
Primary completion: 2023-09-21
Completion: 2023-09-21

Publications

Results Mensah-Osman E, Mukai Y, Wang A, Matuszczak M, Saldien V, Leibensperger H, Speek M, Locco A, Wrishko R, Gee A, Herring WJ; New Collective Author. Sugammadex for Reversal of Neuromuscular Blockade in Neonates and Infants Less than 2 Years Old: Results from a Phase IV Randomized Clinical Trial. Anesthesiology. 2025 Aug 1;143(2):300-312. doi: 10.1097/ALN.0000000000005535. Epub 2025 May 5.

Drugs

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

Indications

No indication recorded.