CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 32 enrolled
Drug / intervention
Sugammadex Injection 2mg/kg +3 moredrug
Likely dose
Sugammadex Injection 2mg/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/NCT04347486
NCT04347486Phase 2Completed

Pharmacokinetic-pharmacodynamic Analysis of Conventional Reversal of Rocuronium-induced Neuromuscular Blockade by Sugammadex in Children

Seoul National University Hospital·interventional·Posted Apr 15, 2020·Updated Feb 10, 2022

In Brief

A Phase 2 clinical trial evaluating Sugammadex Injection 2mg/kg, Sugammadex Injection 4mg/kg, and 2 other interventions for Anesthesia, General and Neuromuscular Blockade. Completed, enrolled 32 participants across 1 site.

Detailed Summary

This study administers sugammadex sodium to pediatric patients under general anesthesia with rocuronium. Pharmacokinetic and pharmacodynamic analysis are performed based on plasma concentration of sugammadex sodium and monitoring of neuromuscular blockade.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSouth Korea

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedApr 15, 2020
Enrollment StartApr 29, 2020
Primary CompletionDec 7, 2021
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 6.2 years ago

Interventions

Sugammadex Injection 2mg/kgdrug

Intravenous injection of 2mg/kg of sugammadex sodium on reappearance of T2

Sugammadex Injection 4mg/kgdrug

Intravenous injection of 4mg/kg of sugammadex sodium on reappearance of T2

Sugammadex Injection 8mg/kgdrug

Intravenous injection of 8mg/kg of sugammadex sodium on reappearance of T2

Neuromuscular reversal agent injectiondrug

Intravenous injection of 0.02mg/kg of atropine and 0.03mg/kg of neostigmine