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

2306-198-1445

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.

2023-11-16

2024-10-31

2024-12-31

Recruiting

Early phase I

50

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Sequential allocation to drug dosage according to result of previous participant', 'primaryPurpose': 'SUPPORTIVE_CARE', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 50, 'type': 'ESTIMATED'}}

2023-11-22