Study of Remimazolam Tosilate in Patients Undergoing Diagnostic Upper GI Endoscopy

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety and efficacy of the sedation for Remimazolam or Propofol in patients undergoing diagnostic upper GI endoscopy.

Detailed Description
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This is a multi-center, ,parallel-group, single blind study using Remimazolam or propofol for sedation in patients undergoing diagnostic upper GI endoscopy.Subjects are randomized to different treatment groups (including 1 for Remimazolam Tosilate and 1 for propofol). Fentanyl are permitted during a diagnostic upper GI endoscopy.Efficacy and safety profiles of Remimazolam Tosilate are to be evaluated.

Official Title
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A Phase Ⅲ, Multicentre, Randomized, Single-blinded Study to Evaluate the Safety and Efficacy of the Sedation for Remimazolam or Propofol in Patients Undergoing Diagnostic Upper GI Endoscopy

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: subjects aged 18-60 years； intending to undergo diagnostic upper GI endoscopy; ASA( American Society of Anesthesiologists) I or II； 18 kg/m²<BMI(Body Mass Index)<30 kg/m²; the operation time of gastroscopy is not more than 30 min； Signed informed consent. Exclusion Criteria: Patients need to be Complicated gastroscopy; Patients need to be Tracheal intubation; Patients with respiratory management difficulties (Modified Mallampati grade IV）; one or more of the laboratory findings fall out of the limitations for this study(platelet,hemoglobin,aspartate aminotransferase,etc.); A history of drug abuse and / or alcohol abuse 2 years prior to the screening period； allergic to drugs used in the study; pregnant women or those in lactation period The subject has participated in other clinical trial within the 3 months prior to randomization.

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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Remimazolam Tosilate<br>Remimazolam Tosilate at 5mg for initial dose | Drug: Remimazolam Tosilate<br>* Initial dose plus supplemental doses as necessary<br>|
| Active Comparator: Propofol<br>Propofol at 1.5mg/kg for initial dose | Drug: Propofol<br>* Initial dose plus supplemental doses as necessary<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of successful sedation | successful sedation rate as measured by the proportion of subjects who experienced successful sedation during diagnostic upper GI endoscopy. | approximately 3 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sedation induction time | Sedation induction time is defined as from start of study drug injection to the first time of MOAA/S（The Observer's Assessment of Alertness/Sedation Scale） ≤ 3. | approximately 3 hours | 
| Sedation recovery time | Sedation induction time is defined as from stop of study drug injection to be wide awake. | approximately 3 hours | 
| rate of hypotension | rate of hypotension as measured by the proportion of subjects who experienced hypotension during a diagnostic upper GI endoscopy | approximately 3 hours | 
| rate of respiratory depression | rate of respiratory depression as measured by the proportion of subjects who experienced respiratory depression during a diagnostic upper GI endoscopy | approximately 3 hours |