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The purpose of this study is to evaluate the efficacy and safety of Remimazolam Tosilate for Injection for sedation in the ICU.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Remimazolam Tosilate for Injection | Experimental |
| |
| Propofol Medium and Long Chain Fat Emulsion Injection | Active Comparator |
|
| 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 24 hours after administration of research drug |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of time maintaining target sedation in the entire drug administering time. | within 24 hours after administration of research drug | |
| Percentage of subjects receiving rescue sedation | within 24 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 First Affiliated Hospital, Sun Yat-sen University | Guangzhou | Guangdong | 510080 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41855428 | Derived | Guan X, Liu N, Lin F, Yu J, Yang M, Zhou Q, Chen K, Yu X, Huang X, Zhu J, Lyu J, Gui C, Hu Z, Zheng S, He B, Wang M, Yu Z, Ma X, Lv A, Zhang J, Xu J, Ye J, Gong J, Tian X, Zhou J, Zhou F, Yu L, He W, Li X, Yin T, Zhao H, Ding Y, Chen M. Efficacy and Safety of Remimazolam Tosylate versus Propofol for Sedation of Postoperative Mechanically Ventilated Patients in Intensive Care Units: A Multicenter, Randomized, Single-blind, Noninferiority, Phase 3 Trial. Anesthesiology. 2026 Jul 1;145(1):72-83. doi: 10.1097/ALN.0000000000006047. Epub 2026 Mar 19. |
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| Propofol Medium and Long Chain Fat Emulsion Injection | Drug | Loading dose: 0.3-0.5mg/kg Maintenance dose: IV Propofol Medium and Long Chain Fat Emulsion Injection, dose range 0.3-4.0mg/kg/h, increment or decrement of 0.3-0.6mg/kg/h |
|
| The number of additional doses of the research drug | within 24 hours after administration of research drug] |
| The total dosage of Fentanyl | within 24 hours after administration of research drug |
| Wake-up time. | within 6 hours after stopping the research drug |
| Stopping the research drug to extubation time. | within 6 hours after stopping the research drug |
| Nursing scale score | follow-up period (approx. 5-10 minutes) |