Status:
UNKNOWN
Dose Finding Study for Remimazolam in Children
Lead Sponsor:
Seoul National University Hospital
Conditions:
Drug Effect
Eligibility:
All Genders
2-8 years
Phase:
PHASE2
Brief 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 a...
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. ...
Eligibility Criteria
Inclusion
- Children scheduled to undergo general anesthesia or sedation
- American Society of Anesthesiologist Physical Status of 1 or 2
Exclusion
- 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
Key Trial Info
Start Date :
November 16 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT05975255
Start Date
November 16 2023
End Date
December 31 2024
Last Update
November 22 2023
Active Locations (1)
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1
Seoul National University Hospital
Seoul, South Korea, 03080