Finding the right dose of remimazolam for sedation in young children
Effective Dose of Remimazolam for Loss of Consciousness in Children: A Prospective Dose Finding Study
This study is testing the right amount of a medication called remimazolam to safely help young children aged 2 to 8 fall asleep for medical procedures.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 2 Years to 8 Years |
| Sex | All |
| Sponsor | Seoul National University Hospital Academic / other |
| Locations | 1 site (Seoul) |
| Trial ID | NCT05975255 on ClinicalTrials.gov |
What this trial studies
This study aims to determine the effective dose of remimazolam for inducing loss of consciousness in children aged 2 to 8 years. Participants will receive intravenous remimazolam, which will be administered over 30 seconds, and the researchers will assess sedation after 2 minutes. The study employs an up-and-down method with a biased-coin design to adjust the dosage based on whether the previous participant was sedated. The goal is to establish the effective dose (ED90) for this age group.
Who should consider this trial
Good fit: Ideal candidates are children aged 2 to 8 years scheduled for general anesthesia or sedation with an American Society of Anesthesiologist Physical Status of 1 or 2.
Not a fit: Patients with respiratory issues, hypersensitivity to certain medications, or other specific health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a safe and effective sedation protocol for young children undergoing procedures requiring anesthesia.
How similar studies have performed: Other studies have explored sedation in children, but this specific approach to determining the effective dose of remimazolam is novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Seoul
- Seoul National University Hospital — Seoul, Korea, Republic of (Recruiting)
Study contacts
- Principal investigator: Jin-Tae Kim, M.D., Ph.D. — Seoul National University Hospital
- Study coordinator: Sang-Hwan Ji, M.D., Ph.D.
- Email: jsh1@snu.ac.kr
- Phone: 82-2-2072-3661
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.