NCT05975255

Dose Finding Study for Remimazolam in Children

Effective Dose of Remimazolam for Loss of Consciousness in Children: A Prospective Dose Finding Study

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 2 Years – 8 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Drug Effect

Interventions

Type	Name	Description
DRUG	Remimazolam besylate	Intravenous administration of predetermined dose of Byfavo for 30 seconds

Timeline

• Start date: 2023-11-16
• Primary completion: 2024-10-31
• Completion: 2024-12-31
• First posted: 2023-08-03
• Last updated: 2023-11-22

Locations

1 site across 1 country: South Korea