A Trial of Efficacy and Safety of Remimazolam Tosilate for Injection in Local Anesthesia Assisted Sedation

Study Overview
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Brief Summary
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To evaluate the efficacy and safety of Remimazolam Tosilate for injection in local anesthesia assisted sedation, and to explore the dose range of remazolam toluenesulfonate for injection in local anesthesia assisted sedation.

Official Title
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Efficacy and Safety of Remimazolam Tosilate for Injection in Local Anesthesia Assisted Sedation -- a Multicenter, Randomized, Single Blind, Positive Drug Parallel Controlled Phase II Clinical Trial

Conditions
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Local Anesthesia Assisted Sedation

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Able and willing to provide a written informed consent Subjects requiring local anesthesia assisted sedation Male or female Meet the weight standard Conform to the ASA Physical Status Classification Exclusion Criteria: Previous respiratory or pulmonary diseases Subjects who had received general anesthesia Subjects with a history of myocardial infarction or unstable angina pectoris Subjects with atrioventricular block or cardiac insufficiency Subjects with a history of ischemic stroke or transient ischemic attack Subjects with poor blood pressure control after medication Subjects with abnormal clotting function Subjects with a history of mental illness and a history of cognitive impairment epilepsy Subjects with a history or possibility of a difficult airway Subject with a history of substance abuse and drug abuse Abnormal values in the laboratory Allergic to a drug ingredient or component Pregnant or nursing women No birth control during the specified period of time Participated in clinical trials of other drugs (received experimental drugs) The inestigators determined that other conditions were inappropriate for participation in this clinical trial

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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
Interventional Model Description: Remimazolam Tosilate compared with Propofol Injection
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group A/B<br>Treatment group A: Remimazolam Tosilate Treatment group B: Remimazolam Tosilate | Drug: Remimazolam Tosilate<br>* Treatment group A: Remimazolam Tosilate; high dose Treatment group B: Remimazolam Tosilate; low dose<br>|
| Active Comparator: Treatment group C<br>Treatment group C: Propofol Injection. | Drug: Propofol Injection.<br>* Treatment group C: Propofol Injection.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The time to maintain target sedation as a percentage of the total study administration time. |  | through study completion,an average of about 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects who achieved target sedation within 3 minutes after starting intravenous injection of load dose test drugs; |  | 3 minutes after administration | 
| Proportion of subjects receiving remedial sedation; |  | through study completion,an average of about 1 hour | 
| The time from the start of intravenous injection of load dose test drug to the first achievement of target sedation; |  | Time to achieve target sedation, an average of about 4 minutes | 
| The time from stopping infusion of test drugs to reaching MOAA/S level 5 for the first time after operation |  | Recovery time, an average of about 7 minutes | 
| Anesthesiologists' satisfaction with sedation |  | through study completion,an average of about 1 hour | 
| Evaluation of subjects' satisfaction with sedation treatment; |  | through study completion,an average of about 1 hour | 
| Incidence of anterograde amnesia. |  | through study completion,an average of about 1 hour |