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The purpose of this study is to find out the optimal dose for Remimazolam Tosilate as an intravenous general anaesthetic drug in operations and to determine its efficacy and safety profile comparing to propofol.
This is an multi-center，double-blinded，parallel and control study using Remimazolam or propofol for anesthesia in operations.Subjects are randomized to different treatment groups (including 3 for Remimazolam Tosilate and 1 for propofol) and anaesthetics are pumped contimuously into bodies.Analgesics and muscle relaxants are permitted during operations.Efficacy，safety and pharmacokinetic/pharmacodynamic profiles of Remimazolam Tosilate are to be evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Remimazolam Tosilate 1 | Experimental | IV pumping of Remimazolam Tosilate at 6mg/kg/h for anesthesia induction |
|
| Remimazolam Tosilate 2 | Experimental | intravenous pumping of Remimazolam Tosilate at 12mg/kg/h for anesthesia induction |
|
| Remimazolam Tosilate 3 | Experimental | intravenous pumping of Remimazolam Tosilate at 18mg/kg/h for anesthesia induction |
|
| Propofol | Active Comparator | single IV bolus of Propofol at 2.0-2.5mg/kg for anesthesia induction |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remimazolam Tosilate | Drug | IV pumping for anesthesia |
|
| Measure | Description | Time Frame |
|---|---|---|
| successful anaesthesia rate as measured by the proportion of subjects who experienced succesful anesthesia during operations | an average of 3 hours (immediately after opaerations) |
| Measure | Description | Time Frame |
|---|---|---|
| bispectral index(BIS) during anaesthesia as measured by bispectral index machine | every 5 minutes | |
| recovery time as measured by time | an average of 3 hours (after cessation of anesthetics pumping) |
| Measure | Description | Time Frame |
|---|---|---|
| rate of improper-depths sedation as measured by the proportion of subjects who experienced too-deep or too-shallow anesthesia during operations | an average of 3 hours (after anesthesia) | |
| rate of hypotention as measured by the proportion of subjects who experienced hypotention during operations |
Inclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking 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 | IV bolus for anesthesia |
|
| induction time as measured by time | 1-10 minutes (from the begining of anesthetics) |
| an average of 3 hours (after anesthesia) |
| rate of hyoxemia as measured by the proportion of subjects who experienced hyoxemia during operations | an average of 3 hours (after anesthesia) |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |