Remimazolam Bolus for General Anesthesia

Study Overview
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Brief Summary
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It is important to estimate the adequate dose of remimazolam intravenous bolus injection to induce the loss of consciousness. We will determine the ED50 and ED95 of remimazolam intravenous bolus on the loss of consciousness in patients undergoing general anesthesia.

Official Title
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ED50 and ED95 of Remimazolam Intravenous Bolus on the Loss of Consciousness in Patients Undergoing General Anesthesia

Conditions
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Loss of Consciousness

Intervention / Treatment
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* Drug: 0.02 mg/kg, age<65
* Drug: 0.07 mg/kg, age<65
* Drug: 0.12 mg/kg, age<65
* Drug: 0.17 mg/kg, age<65
* Drug: 0.22 mg/kg, age<65
* Drug: 0.27 mg/kg, age<65
* Drug: 0.02 mg/kg, age≥65
* Drug: 0.07 mg/kg, age≥65
* Drug: 0.12 mg/kg, age≥65
* Drug: 0.17 mg/kg, age≥65
* Drug: 0.22 mg/kg, age≥65
* Drug: 0.27 mg/kg, age≥65


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged 19 years old or older, with American Society of Anesthesiologists Physical Status 1-3, and scheduled for general anesthesia Exclusion Criteria: Patients scheduled for liver surgery Uncontrolled hypertension Uncontrolled diabetes mellitus Liver disease Kidney disease Intolerance or hypersensitivity to benzodiazepine Addiction Glaucoma Heart failure Peripheral vascular disease Obstuctive lung disease Patients scheduled for regional anesthesia before general anesthesia Pregnancy

Ages Eligible for Study
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Minimum Age: 19 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: Other
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1 (0.02 mg/kg, age<65)<br>Remimazolam of 0.02 mg/kg will be infused in patients aged<65. | Drug: 0.02 mg/kg, age<65<br>* Remimazolam of 0.02 mg/kg will be infused in patients aged<65.<br>|
| Active Comparator: 2 (0.07 mg/kg, age<65)<br>Remimazolam of 0.07 mg/kg will be infused in patients aged<65. | Drug: 0.07 mg/kg, age<65<br>* Remimazolam of 0.07 mg/kg will be infused in patients aged<65.<br>|
| Active Comparator: 3 (0.12 mg/kg, age<65)<br>Remimazolam of 0.12 mg/kg will be infused in patients aged<65. | Drug: 0.12 mg/kg, age<65<br>* Remimazolam of 0.12 mg/kg will be infused in patients aged<65.<br>|
| Active Comparator: 4 (0.17 mg/kg, age<65)<br>Remimazolam of 0.17 mg/kg will be infused in patients aged<65. | Drug: 0.17 mg/kg, age<65<br>* Remimazolam of 0.17 mg/kg will be infused in patients aged<65.<br>|
| Active Comparator: 5(0.22 mg/kg, age<65)<br>Remimazolam of 0.22 mg/kg will be infused in patients aged<65. | Drug: 0.22 mg/kg, age<65<br>* Remimazolam of 0.22 mg/kg will be infused in patients aged<65.<br>|
| Active Comparator: 6(0.27 mg/kg, age<65)<br>Remimazolam of 0.27 mg/kg will be infused in patients aged<65. | Drug: 0.27 mg/kg, age<65<br>* Remimazolam of 0.27 mg/kg will be infused in patients aged<65.<br>|
| Active Comparator: 7 (0.02 mg/kg, age≥65)<br>Remimazolam of 0.02 mg/kg will be infused in patients aged≥65. | Drug: 0.02 mg/kg, age≥65<br>* Remimazolam of 0.02 mg/kg will be infused in patients aged≥65.<br>|
| Active Comparator: 8 (0.07 mg/kg, age≥65)<br>Remimazolam of 0.07 mg/kg will be infused in patients aged≥65. | Drug: 0.07 mg/kg, age≥65<br>* Remimazolam of 0.07 mg/kg will be infused in patients aged≥65.<br>|
| Active Comparator: 9 (0.12 mg/kg, age≥65)<br>Remimazolam of 0.12 mg/kg will be infused in patients aged≥65. | Drug: 0.12 mg/kg, age≥65<br>* Remimazolam of 0.12 mg/kg will be infused in patients aged≥65<br>|
| Active Comparator: 10 (0.17 mg/kg, age≥65)<br>Remimazolam of 0.17 mg/kg will be infused in patients aged≥65. | Drug: 0.17 mg/kg, age≥65<br>* Remimazolam of 0.17 mg/kg will be infused in patients aged≥65.<br>|
| Active Comparator: 11 (0.22 mg/kg, age≥65)<br>Remimazolam of 0.22 mg/kg will be infused in patients aged≥65. | Drug: 0.22 mg/kg, age≥65<br>* Remimazolam of 0.22 mg/kg will be infused in patients aged≥65.<br>|
| Active Comparator: 12 (0.27 mg/kg, age≥65)<br>Remimazolam of 0.27 mg/kg will be infused in patients aged≥65. | Drug: 0.27 mg/kg, age≥65<br>* Remimazolam of 0.27 mg/kg will be infused in patients aged≥65.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Loss of consciousness within 5 minutes | Loss of consciousness will be evaluated at 5 minutes after infusion. | At 5 minutes after infusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to loss of consciousness | Time to loss of consciousness will be assessed at 5 minutes after infusion. | At 5 minutes after infusion (time to loss of consciousness) | 
| blood pressure | Blood pressure will be measured at 0, 1, 2, 3, 4, 5 minutes after infusion. | At 5 minutes after infusion | 
| heart rate | Heart rate will be measured at 0, 1, 2, 3, 4, 5 minutes after infusion. | At 5 minutes after infusion | 
| sedline | Sedline will be measured at 0, 1, 2, 3, 4, 5 minutes after infusion. | At 5 minutes after infusion |