A 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 find out the optimal dose for Remimazolam Tosilate as a procedural sedative during a diagnostic upper GI endoscopy and to assess its efficacy and safety profile comparing to propofol.

Detailed Description
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This is an multi-center,single-blinded,parallel-group,dose-finding study using Remimazolam or propofol for sedation in patients undergoing diagnostic upper GI endoscopy.Subjects are randomized to different treatment groups (including 4 for Remimazolam Tosilate and 1 for propofol).Lidocaine and fentanyl are permitted during a diagnostic upper GI endoscopy.Efficacy and safety profiles of Remimazolam Tosilate are to be evaluated.

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 American Society of Anesthesiologists Physical Status Score (ASA PS) I or II； 18 kg/m²<BMI(Body Mass Index)<30 kg/m². Exclusion Criteria: Patients with a suspected upper GI bleed an conditions predisposing to hemorrhage at the discretion of the investigator; 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; 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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Remimazolam Tosilate 1<br>IV of Remimazolam Tosilate at 5mg for initial dose | Drug: Remimazolam Tosilate<br>* Initial dose plus supplemental doses as necessary.<br>|
| Experimental: Remimazolam Tosilate 2<br>IV of Remimazolam Tosilate at 7mg for initial dose | Drug: Remimazolam Tosilate<br>* Initial dose plus supplemental doses as necessary.<br>|
| Experimental: Remimazolam Tosilate 3<br>IV of Remimazolam Tosilate at 8mg for initial dose | Drug: Remimazolam Tosilate<br>* Initial dose plus supplemental doses as necessary.<br>|
| Experimental: Remimazolam Tosilate 4<br>IV of Remimazolam Tosilate at 5mg for initial dose.At the end of the endoscopy, flumazenil was injected. | Drug: Remimazolam Tosilate<br>* Initial dose plus supplemental doses as necessary.<br>|
| Active Comparator: Propofol<br>IV of 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 |
| --- | --- | --- |
| successful sedation rate as measured by the proportion of subjects who experienced successful sedation during diagnostic upper GI endoscopy. |  | From start of study drug injection to patient discharge (approx. 3 hours) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| recovery time as measured by time |  | After the last of study drug injection to patient discharge (approx. 3 hours) | 
| rate of hypotension as measured by the proportion of subjects who experienced hypotension during a diagnostic upper GI endoscopy |  | From start of study drug injection to patient discharge (approx. 3 hours) | 
| rate of hypoxaemia as measured by the proportion of subjects who experienced hypoxaemia during a diagnostic upper GI endoscopy |  | From start of study drug injection to patient discharge (approx. 3 hours) | 
| rate of respiratory depression as measured by the proportion of subjects who experienced respiratory depression during a diagnostic upper GI endoscopy |  | From start of study drug injection to patient discharge (approx. 3 hours) | 
| pain on injection was assessed by the patient immediately after administration of the study drug |  | 1-10 minutes (from the beginning of sedation )] |