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The study is being conducted to evaluate the efficacy and safety of remimazolam tosilate compared to propofol for general anesthesia during elective surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group A | Experimental | IV pumping of remimazolam tosilate at 6mg/kg/h for anesthesia induction and 1mg/kg/h for anesthesia maintenance |
|
| Treatment B | Active Comparator | IV pumping of propofol at 120~150mg/kg/h for anesthesia induction and 3~12mg/kg/h for anesthesia maintenance |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remimazolam Tosilate | Drug | For induction and maintenance of general anesthesia |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage(%) of paticipants who experienced successful anesthesia during operation in each group | Average of 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Time from start of investigational medicinal product administration to loss of consciousness | Average of 2 hours | |
| Time from stop of investigational medicinal product to MOAA/S Score=5 | Average of 2 hours |
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Inclution Criteria:
Exclusion criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 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 |
For induction and maintenance of general anesthesia |
|
| Time from stop of investigational medicinal product to Aldrete Score>9 | Average of 2 hours |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |