Sugammadex for Reversal of Neuromuscular Blockade in Neonates and Infants Less than 2 Years Old: Results from a Phase IV Randomized Clinical Trial.

ABSTRACT:

Background

Sugammadex is well tolerated and effective for reversing neuromuscular blockade (NMB) in adults and children as young as 2 yr old. There is little information on its use in younger children. The aim of this study was to evaluate the efficacy and tolerability of sugammadex in children under 2 yr of age.

Methods

This was a phase IV, randomized, parallel-group, multicenter clinical trial of sugammadex in participants aged birth to less than 2 yr (NCT03909165). Part A was open label and included pharmacokinetic assessments to determine whether sugammadex dose adjustment for part B was necessary based on age. Part B was double-blind and evaluated doses of 2 and 4 mg/kg sugammadex. Participants were randomized to (1) moderate NMB and reversal with 2 mg/kg sugammadex; (2

SUBMITTER: Mensah-Osman E 

PROVIDER: S-EPMC12227211 | biostudies-literature | 2025 Aug

REPOSITORIES: biostudies-literature