A Clinical Study of Remimazolam Tosilate Compared to Propofol for General Anesthesia During Elective Surgery

Study Overview
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Brief Summary
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The study is being conducted to evaluate the efficacy and safety of remimazolam tosilate compared to propofol for general anesthesia during elective surgery.

Official Title
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A Multicenter, Randomized, Single-blind, Parallel and Control Phase III Trial Evaluating the Efficacy and Safety of Remimazolam Tosilate Compared to Propofol for General Anesthesia During Elective Surgery.

Conditions
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Anesthesia for Elective Surgery Patients

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


Participation Criteria
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Eligibility Criteria
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Inclution Criteria: 18 60 years, female or male Patients scheduled for an elective surgical procedure(mechanical ventilation via endotracheal tube) BMI: 18 30 kg/m2 Patients understand clearly and participate in the study voluntarily, and sign the informed consent Exclusion criteria: Patients scheduled for emergency surgery Patients with a history of drug abuse and / or alcohol abuse 2 years prior to the screening period One or more of the laboratory findings fall out of the limitations for this study(platelet,hemoglobin,aspartate aminotransferase,etc.) Pregnant women or those in lactation period Allergic to drugs used in the study Patients with respiratory management difficulties (Modified Mallampati grade IV) Patients have participated in other clinical trial within the 3 months prior to randomization Any patient judged by the Principal Investigator (PI) or Sub-Investigator to be inappropriate for the subject for any other reason

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

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group A<br>IV pumping of remimazolam tosilate at 6mg/kg/h for anesthesia induction and 1mg/kg/h for anesthesia maintenance | Drug: Remimazolam Tosilate<br>* For induction and maintenance of general anesthesia<br>|
| Active Comparator: Treatment B<br>IV pumping of propofol at 120 150mg/kg/h for anesthesia induction and 3 12mg/kg/h for anesthesia maintenance | Drug: Propofol<br>* For induction and maintenance of general anesthesia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage(%) of paticipants who experienced successful anesthesia during operation in each group |  | Average of 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time from start of investigational medicinal product administration to loss of consciousness |  | Average of 2 hours | 
| Time from stop of investigational medicinal product to MOAA/S Score=5 |  | Average of 2 hours | 
| Time from stop of investigational medicinal product to Aldrete Score>9 |  | Average of 2 hours |