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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Remimazolam Tosilate | Experimental | Remimazolam Tosilate at 5mg for initial dose |
|
| Propofol | Active Comparator | Propofol at 1.5mg/kg for initial dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remimazolam Tosilate | Drug | Initial dose plus supplemental doses as necessary |
| |
| 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 |
| 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 |
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Inclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical trial Ethnics Committee of Peking Union Medical College Hospital | Beijing | Beijing Municipality | 010 | China |
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| ID | Term |
|---|---|
| D015742 | Propofol |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Propofol |
| Drug |
Initial dose plus supplemental doses as necessary |
|
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 |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |