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To evaluate the efficacy and safety of Remimazolam Tosilate for injection in local anesthesia assisted sedation, and to explore the dose range of remazolam toluenesulfonate for injection in local anesthesia assisted sedation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group A/B | Experimental | Treatment group A: Remimazolam Tosilate Treatment group B: Remimazolam Tosilate |
|
| Treatment group C | Active Comparator | Treatment group C: Propofol Injection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remimazolam Tosilate | Drug | Treatment group A: Remimazolam Tosilate; high dose Treatment group B: Remimazolam Tosilate; low dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| The time to maintain target sedation as a percentage of the total study administration time. | through study completion,an average of about 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects who achieved target sedation within 3 minutes after starting intravenous injection of load dose test drugs; | 3 minutes after administration | |
| Proportion of subjects receiving remedial sedation; | through study completion,an average of about 1 hour |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West China Hospital | Chengdu | Sichuan | 610041 | 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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Remimazolam Tosilate compared with Propofol Injection
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| Propofol Injection. | Drug | Treatment group C: Propofol Injection. |
|
| The time from the start of intravenous injection of load dose test drug to the first achievement of target sedation; | Time to achieve target sedation, an average of about 4 minutes |
| The time from stopping infusion of test drugs to reaching MOAA/S level 5 for the first time after operation | Recovery time, an average of about 7 minutes |
| Anesthesiologists' satisfaction with sedation | through study completion,an average of about 1 hour |
| Evaluation of subjects' satisfaction with sedation treatment; | through study completion,an average of about 1 hour |
| Incidence of anterograde amnesia. | through study completion,an average of about 1 hour |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |