A Clinical Study of Remimazolam Tosilate in Patients Undergoing Bronchoscopy

Study Overview
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Brief Summary
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A multicenter, randomized, single-blind, active controlled, parallel group study comparing remimazolam tosilate to propofol in patients undergoing bronchoscopy.

Official Title
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A Phase III Clinical Study Evaluating the Efficacy and Safety of Remimazolam Tosilate Compared to Propofol in Patients Undergoing Bronchoscopy

Conditions
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Sedation

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: 18 80 years, female or male Patients scheduled for an bronchoscopy procedure 18 kg/m2<BMI<30kg/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 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: 80 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: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Remimazolam Tosilate<br> | Drug: Remimazolam Tosilate<br>* Intravenous injection at a dose of 0.3mg/kg for sedation induction and continuous intravenous infusion at an initiative dose of 1 mg/kg/h for sedation maintenance.<br>|
| Active Comparator: Propofol<br> | Drug: Propofol<br>* Intravenous injection at a dose of 1.5 2.5mg/kg for sedation induction and continuous intravenous infusion at the dose of 0 12 mg/kg/h for sedation maintenance<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage (%) of participants who experienced successful sedation in undergoing bronchoscopy in each group |  | From the onset of administration of the study drug to removal of bronchoscope on Day 1 of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time from start of investigational medicinal product administration to loss of consciousness |  | From the onset of administration of the study drug to unconsciousness on Day 1 of treatment | 
| Time from stop of investigational medicinal product to MOAA/S Score=5 |  | From the last dose of study drug until the patient has recovered to fully alert on Day 1 of treatment | 
| Time from stop of investigational medicinal product to Aldrete Score≥9 |  | From the end of administration of the study drug until the patient reaches the modified Aldrete's system score of ≥9 points on Day 1 of treatment |