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A multicenter, randomized, single-blind, active controlled, parallel group study comparing remimazolam tosilate to propofol in patients undergoing bronchoscopy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Remimazolam Tosilate | Experimental |
| |
| Propofol | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remimazolam Tosilate | Drug | Intravenous injection at a dose of 0.3mg/kg for sedation induction and continuous intravenous infusion at an initiative dose of 1 mg/kg/h for sedation maintenance. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage (%) of participants who experienced successful sedation in undergoing bronchoscopy in each group | From the onset of administration of the study drug to removal of bronchoscope on Day 1 of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Time from start of investigational medicinal product administration to loss of consciousness | From the onset of administration of the study drug to unconsciousness on Day 1 of treatment | |
| Time from stop of investigational medicinal product to MOAA/S Score=5 |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peking Union Medical College Hospital | Peking Union Medical College Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Beijing | 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 | Intravenous injection at a dose of 1.5~2.5mg/kg for sedation induction and continuous intravenous infusion at the dose of 0~12 mg/kg/h for sedation maintenance |
|
| From the last dose of study drug until the patient has recovered to fully alert on Day 1 of treatment |
| Time from stop of investigational medicinal product to Aldrete Score≥9 | From the end of administration of the study drug until the patient reaches the modified Aldrete's system score of ≥9 points on Day 1 of treatment |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |