the Efficacy and Safety of Sugammadex in Children 0-2 Years Old
Status:
Unknown status
Trial end date:
2019-11-20
Target enrollment:
Participant gender:
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
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
Federal Research Institute of Pediatric Hematology, Oncology and Immunology