CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 40 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/NCT03943888
NCT03943888Phase 2Completed

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

Seoul National University Hospital·interventional·Posted May 9, 2019·Updated Nov 14, 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 40 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
2020202120222023202420252026
First PostedMay 9, 2019
Enrollment StartAug 12, 2019
Primary CompletionFeb 20, 2020
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 7.1 years ago

Interventions

Sugammadex Injection 2mg/kgdrug

Intravenous injection of 2mg/kg of sugammadex sodium 15 minutes after rocuronium administration

Sugammadex Injection 4mg/kgdrug

Intravenous injection of 4mg/kg of sugammadex sodium 15 minutes after rocuronium administration

Sugammadex Injection 8mg/kgdrug

Intravenous injection of 8mg/kg of sugammadex sodium 15 minutes after rocuronium administration

Neuromuscular reversal agent injectiondrug

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