drugset / Trial / NCT03728543

the Efficacy and Safety of Sugammadex in Children 0-2 Years Old

NCT03728543

Non-randomizedParallel-groupOpen-labelTreatment

Summary

Sugammadex is a selective antidote to muscle relaxants rocuronium bromide and vecuronium bromide. Sugammadex is a modified gamma-cyclodextrin, a compound that selectively binds rocuronium bromide and vecuronium bromide. It forms a complex with them in the blood plasma, which leads to the decrease in the concentration of muscle relaxant binding to nicotinic receptors in the neuromuscular synapse. The result is the the elimination of neuromuscular blockade caused by rocuronium bromide or vecuronium bromide. Sugammadex is used to eliminate neuromuscular blockade caused by rocuronium bromide in children aged 2 years and adolescents in standard clinical situations. The aim of the study is to prove the efficacy and safety of sugammadex in children under 2 years

Timeline

Start
2018-11-15
Primary completion
2019-11-15
Completion
2019-11-20

Drugs

EvaluationDrugModalityDoseRoute
Subject Sugammadex Other / unclassified 2 mg/kg Intravenous