Dose Finding Study for Remimazolam in Children

Status Recruiting

Clinical Trial Summary

This study aims to find effective dose of remimazolam for inducing loss of consciousness in children aged 2 to 8 years old. We will explore ED90 of remimazolam for loss of consciousness in 2 minutes after intravenous injection, via a up-and-down method with biased-coin design.

Clinical Trial Description

We will administer remimazolam intravenously to the study participants. Remimazolam will be infused in 30 seconds to the participants, and we will wait for 2 minutes for the participants be sedated. When a participant was not sedated in 2 minutes, dose of remimazolam in the next participant will be escalated by 0.05mg/kg. When a participant was sedated in 2 minutes, dose of remimazolam in the next participant will be decreased by 0.05mg/kg or maintained as same. The probability of decrement and maintenance will be 90% and 10% respectively. The dose of remimazolam in the first participant of the study will be 0.05mg/kg. We will collect the results and obtain ED90 of remimazolam for loss of consciousness in children aged 2 to 8 years old. ;

Study Design

Related Conditions & MeSH terms

Drug Effect

Clinical Trial Details

NCT number	NCT05975255
Study type	Interventional
Source	Seoul National University Hospital
Contact	Sang-Hwan Ji, M.D., Ph.D.
Phone	82-2-2072-3661
Email	jsh1@snu.ac.kr
Status	Recruiting
Phase	Phase 2
Start date	November 16, 2023
Completion date	December 31, 2024

View Details

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