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The purpose of this study is to evaluate the efficacy and safety of Remimazolam Tosilate for Injection for prolonged sedation(≥72h) during mechanical ventilation in the ICU.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Remimazolam Tosilate | Experimental | IV of Remimazolam Tosilate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remimazolam Tosilate | Drug | Loading dose: 0.08mg/kg , Maintenance dose: IV remimazolam tosilate, dose range 0-2.0mg/kg/h, increment or decrement of 0.1-0.2mg/kg/h |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of sedation success, sedation success is defined as the percentage of time maintaining target sedation in the entire drug administering time ≥ 70% without rescue sedation. | within 72 hours after administration of research drug |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of time maintaining target sedation in the entire drug administering time. | within 72 hours after administration of research drug | |
| Percentage of subjects receiving rescue sedation and the average dosage of rescue sedation | within 72 hours after administration of research drug |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Affiliated Hospital of Guizhou Medical University | Guiyang | Guizhou | 550001 | China |
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| Percentage of subjects receiving rescue analgesia and the average dosage of rescue analgesia | within 72 hours after administration of research drug |
| Wake-up time. | after stopping the research drug |
| Evaluation of nursing difficulty. | follow-up period (approx. 5-10 minutes) |
| Mechanical ventilation time. | at the time of extubation |