A Study Comparing Remimazolam Tosilate and Propofol for Intravenous General Anaesthesia in Operations

Study Overview
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Brief Summary
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The purpose of this study is to find out the optimal dose for Remimazolam Tosilate as an intravenous general anaesthetic drug in operations and to determine its efficacy and safety profile comparing to propofol.

Detailed Description
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This is an multi-center，double-blinded，parallel and control study using Remimazolam or propofol for anesthesia in operations.Subjects are randomized to different treatment groups (including 3 for Remimazolam Tosilate and 1 for propofol) and anaesthetics are pumped contimuously into bodies.Analgesics and muscle relaxants are permitted during operations.Efficacy，safety and pharmacokinetic/pharmacodynamic profiles of Remimazolam Tosilate are to be evaluated.

Conditions
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General Anesthesia

Intervention / Treatment
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* Drug: Remimazolam Tosilate
* Drug: Propofol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: subjects aged 18-60 years； intending to have non-emergency operations； ASA( American Society of Anesthesiologists) I or II； 18 kg/m²<BMI(Body Mass Index)<30 kg/m². Exclusion Criteria: people with contraindications to general anaesthesia; one or more of the laboratory findings fall out of the limitations for this study(platelet,hemoglobin,aspartate aminotransferase,etc.); history of recent use of narcotics,analgesics,anaesthetics and benzodiazepine hypnotics; history of severe cardiovascular disease; uncontrolled blood glucose level; cerebral disease or mental disorder; allergic to drugs used in the study; pregnant women or those in lactation period.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Remimazolam Tosilate 1<br>IV pumping of Remimazolam Tosilate at 6mg/kg/h for anesthesia induction | Drug: Remimazolam Tosilate<br>* IV pumping for anesthesia<br>|
| Experimental: Remimazolam Tosilate 2<br>intravenous pumping of Remimazolam Tosilate at 12mg/kg/h for anesthesia induction | Drug: Remimazolam Tosilate<br>* IV pumping for anesthesia<br>|
| Experimental: Remimazolam Tosilate 3<br>intravenous pumping of Remimazolam Tosilate at 18mg/kg/h for anesthesia induction | Drug: Remimazolam Tosilate<br>* IV pumping for anesthesia<br>|
| Active Comparator: Propofol<br>single IV bolus of Propofol at 2.0-2.5mg/kg for anesthesia induction | Drug: Propofol<br>* IV bolus for anesthesia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| successful anaesthesia rate as measured by the proportion of subjects who experienced succesful anesthesia during operations |  | an average of 3 hours (immediately after opaerations) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bispectral index(BIS) during anaesthesia as measured by bispectral index machine |  | every 5 minutes | 
| recovery time as measured by time |  | an average of 3 hours (after cessation of anesthetics pumping) | 
| induction time as measured by time |  | 1-10 minutes (from the begining of anesthetics) |