Sugammadex Dose Finding Under Two Years Old

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
AgeUp to 23
SponsorSang-Hwan Ji

About this trial

This is a prospective dose-finding study of sugammadex for conventional reversal of rocuronium-induced neuromuscular blockade in children under two years of age. This study will explore 50% effective dose and 95% effective dose of sugammadex for reversal of neuromuscular blockade in less than two minutes under biased coin up-and-down method.

Eligibility criteria

Qualifiers

Childern younger than 2 years old who are scheduled to undergo surgery under general anesthesia

American Society of Anesthesiologists Physical Status 1 or 2

Disqualifiers

History of hypersensitivity to rocuronium or any anesthetics

Presence of cardiovascular or genitourinary disease

Presence of severe renal dysfunction or in need of dialysis

Presence of severe hepatic dysfunction or coagualtion disorder

Trial design

Treatments tested in this trial

  • Sugammadex

Treatment groups

33 Participants
are divided into 1 treatment group

Sponsors and collaborators

Sang-Hwan Ji

Lead sponsor

Seoul National University Hospital

Sponsor institution