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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Remimazolam Tosilate 1 | Experimental | IV of Remimazolam Tosilate at 5mg for initial dose |
|
| Remimazolam Tosilate 2 | Experimental | IV of Remimazolam Tosilate at 7mg for initial dose |
|
| Remimazolam Tosilate 3 | Experimental | IV of Remimazolam Tosilate at 8mg for initial dose |
|
| Remimazolam Tosilate 4 | Experimental | IV of Remimazolam Tosilate at 5mg for initial dose.At the end of the endoscopy, flumazenil was injected. |
|
| Propofol | Active Comparator | IV of 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 |
|---|---|---|
| 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) |
| 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) |
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Inclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Union Medical College Hospital | Beijing | Beijing Municipality | 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. |
|
| 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 )] |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |