Dose Finding Study for Remimazolam in Children
- Registration Number
- NCT05975255
- Lead Sponsor
- Seoul National University Hospital
- 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 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 50
- Children scheduled to undergo general anesthesia or sedation
- American Society of Anesthesiologist Physical Status of 1 or 2
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Study group Remimazolam besylate Remimazolam administration and evaluation of sedative effect
- Primary Outcome Measures
Name Time Method Loss of consciousness From start of remimazolam administration to 2 minute after end of administration Score 3 or more in the University of Michigan Sedation Scale in less than 2 minutes after administration of remimazolam besylate
- Secondary Outcome Measures
Name Time Method Apnea From start of remimazolam administration to 2 minute after end of administration Incidence of apnea after administration of remimazolam besylate
UMSS (University of Michigan Sedation Scale) From start of remimazolam administration to 2 minute after end of administration Serial measurement of University of Michigan Sedation Scale
Heart rate From start of remimazolam administration to 2 minute after end of administration Serial measurement of heart rate
Pulse oximetry From start of remimazolam administration to 2 minute after end of administration Serial measurement of pulse oximetry
Noninvasive mean blood pressure From start of remimazolam administration to 2 minute after end of administration Serial measurement of noninvasive mean blood pressure
Anesthetic depth From start of remimazolam administration to 2 minute after end of administration Serial measurement of electroencephalogram-based anesthetic depth monitoring
Trial Locations
- Locations (1)
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of