CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 145 enrolled
Drug / intervention
Sugammadex 2 mg/kg +3 moredrug
Likely dose
Sugammadex 2 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03909165
NCT03909165Phase 4Completed
CompareCT.gov

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 Aged Birth to <2 Years

Merck Sharp & Dohme LLC·interventional·Posted Apr 9, 2019·Updated Jul 25, 2025

In Brief

A Phase 4 clinical trial evaluating Sugammadex 2 mg/kg, Sugammadex 4 mg/kg, and 2 other interventions for Neuromuscular Blockade. Completed, enrolled 145 participants across 39 sites in 14 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeuromuscular Blockade
CountriesAustralia, Belgium, Brazil, Denmark, Finland, France, Guatemala, Hungary, Malaysia, Mexico, Netherlands, Peru, Russia, United States
Collaborators--

Timeline

Phase 4CompletedFinished
2020202120222023202420252026
First PostedApr 9, 2019
Enrollment StartJul 23, 2019
Primary CompletionSep 21, 2023
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 7.2 years ago

Interventions

Sugammadex 2 mg/kgdrug

For moderate NMB reversal, a single IV bolus of sugammadex (2 mg/kg) will be given after final dose of neuromuscular blocking agent (NMBA; rocuronium or vecuronium) and within 2 minutes of the reappearance of a second twitch (T2) in response to train-of-four (TOF) stimulations.

Sugammadex 4 mg/kgdrug

For deep NMB reversal, a single IV bolus of sugammadex (4 mg/kg) will be given after final dose of NMBA (rocuronium or vecuronium) and within 2 minutes of detection of a target of 1 to 2 post-tetanic counts and no response to TOF stimulations (TOF=0).

Neostigmine + Glycopyrrolatedrug

For moderate NMB reversal, a single i.v. bolus containing both neostigmine (50 μg/kg; up to 5 mg maximum dose) as well as glycopyrrolate (10 μg/kg) will be given after final dose of NMBA (rocuronium or vecuronium) and within 2 minutes of the reappearance of T2 in response to TOF stimulations.

Neostigmine + Atropinedrug

For moderate NMB reversal, a single i.v. bolus containing both neostigmine (50 μg/kg; up to 5 mg maximum dose) as well as atropine (20 μg/kg) will be given after final dose of NMBA (rocuronium or vecuronium) and within 2 minutes of the reappearance of T2 in response to TOF stimulations.