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The purpose of this study is to evaluate the efficacy and safety of Remimazolam Tosilate for Injection for sedation in non-intubated diagnostic and therapeutic procedures
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Remimazolam Tosilate for Injection(5mg) | Experimental |
| |
| Remimazolam Tosilate for Injection(10mg) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remimazolam Tosilate for Injection | Drug | Initial loading dose of 5mg, with additional doses of 2.5mg as necessary |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of sedation success, Sedation success | Rate of sedation success, Sedation success is defined as: 1) Completion of the entire non-intubated diagnostic and therapeutic procedure; 2) No need for additional rescue sedation; 3) During the sedation induction phase, the MOAA/S score should be ≤3 within 2 minutes after the end of the initial dose administration or after ≤2 additional administrations; 4) No more than 2 additional administrations in every 5-minute. | day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of additional administrations. | day 1 | |
| Percentage of subjects needing additional administration. | day 1 | |
| One-time success rate of endoscope insertion during the diagnostic and therapeutic procedure. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qin Liu | Contact | +0518-82342973 | qin.liu@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Hospital, Fudan University | Shanghai | Shanghai Municipality | 200032 | China |
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| Remimazolam Tosilate for Injection | Drug | Initial loading dose of 10mg, with additional doses of 2.5mg as necessary |
|
| day 1 |
| Rate of over-sedation. | day 1 |
| Sedation induction time | day 1 |
| Wake-up time. | day 1 |
| Time to discharge. | day 1 |
| Rate of sedation-related hypotension and rate of sedation-related hypotension needing treatment. | day 1 |
| Rate of respiratory depression during sedation. | day 1 |
| Investigator's Satisfaction with Sedation Assessment: The scoring range is from 0 to 10, where 0 represents dissatisfaction and 10 represents complete satisfaction. | day 1 |
| Participant's satisfaction with Sedation Assessment: The scoring range is from 0 to 10, where 0 represents dissatisfaction and 10 represents complete satisfaction. | day 1 |
| ID | Term |
|---|---|
| D007267 | Injections |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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