Dose Finding Study for Remimazolam in Children

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Drug Effect

Intervention / Treatment
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* Drug: Remimazolam besylate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Sequential Assignment
Interventional Model Description: Sequential allocation to drug dosage according to result of previous participant
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study group<br>Remimazolam administration and evaluation of sedative effect | Drug: Remimazolam besylate<br>* Intravenous administration of predetermined dose of Byfavo for 30 seconds<br>* Other names: Byfavo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Loss of consciousness | Score 3 or more in the University of Michigan Sedation Scale in less than 2 minutes after administration of remimazolam besylate | From start of remimazolam administration to 2 minute after end of administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| UMSS (University of Michigan Sedation Scale) | Serial measurement of University of Michigan Sedation Scale | From start of remimazolam administration to 2 minute after end of administration | 
| Heart rate | Serial measurement of heart rate | From start of remimazolam administration to 2 minute after end of administration | 
| Pulse oximetry | Serial measurement of pulse oximetry | From start of remimazolam administration to 2 minute after end of administration | 
| Noninvasive mean blood pressure | Serial measurement of noninvasive mean blood pressure | From start of remimazolam administration to 2 minute after end of administration | 
| Anesthetic depth | Serial measurement of electroencephalogram-based anesthetic depth monitoring | From start of remimazolam administration to 2 minute after end of administration | 
| Apnea | Incidence of apnea after administration of remimazolam besylate | From start of remimazolam administration to 2 minute after end of administration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dose, Remimazolam, Children