Drug Effect
Conditions
Keywords
Remimazolam, Children, Dose
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.
Interventions
DRUGRemimazolam besylate
Intravenous administration of predetermined dose of Byfavo for 30 seconds
Sponsors
Seoul National University Hospital
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Sequential allocation to drug dosage according to result of previous participant
Eligibility
Sex/Gender
ALL
Age
2 Years to 8 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| Anesthetic depth | From start of remimazolam administration to 2 minute after end of administration | Serial measurement of electroencephalogram-based anesthetic depth monitoring |
| Apnea | From start of remimazolam administration to 2 minute after end of administration | Incidence of apnea after administration of remimazolam besylate |
| Noninvasive mean blood pressure | From start of remimazolam administration to 2 minute after end of administration | Serial measurement of noninvasive mean blood pressure |
Countries
South Korea
Contacts
Primary ContactSang-Hwan Ji, M.D., Ph.D.
Outcome results
None listed