Dose Finding Study for Remimazolam in Children

• Status: Recruiting
• Trial end date: 2024-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seoul National University Hospital

Criteria

Inclusion Criteria:

• Children scheduled to undergo general anesthesia or sedation

• American Society of Anesthesiologist Physical Status of 1 or 2

Exclusion Criteria:

• Presence of Upper respiratory tract infection or any pulmonary disease

• Presence of subglottic stenosis, laryngomalacia, or tracheomalacia

• History of hypersensitivity to benzodiazepines or propofol

• History of hypersensitivity to beans or peanut

• History of seizure

• Presence of arrhythmia, tachycardia, or bradycardia

• Presence of acute closed-angle glaucoma

• Patients with unstable vital sign

• Presence of sleep apnea

• Presence of galactose intolerance, Lapp lactase deficiency, or glucose-galactose absorption disorder

• History of hypersensitivity to dextran 40

• Refusal to enroll by one or more parents or legal guardian

• Other conditions the researchers regarded as inappropriate to enroll