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The purpose of this study is to explore the optimal dose regimen of Remimazolam Tosilate for Injection for sedation in the ICU, as well as preliminarily evaluate the efficacy and safety of Remimazolam Tosilate for Injection for sedation in the ICU.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A:Remimazolam Tosilate | Experimental |
| |
| B:Remimazolam Tosilate | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remimazolam Tosilate | Drug | Loading dose: 0.08mg/kg IV of Remimazolam Tosilate, Maintenance dose: IV remimazolam tosilate, dose range 0-2.0mg/kg/h, increment or decrement of 0.1mg/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 and the average dosage of 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 | 510060 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42164575 | Derived | Liu N, Lin F, Wen J, Yu X, Zhou F, Yu Z, Yang M, Yu L, Lv A, Sun Y, Shen F, He B, Hu Z, Yin T, Li X, Zhao H, Wu J, Chen C, Nie Y, Zuo L, Guan X, Chen M. Efficacy and safety of remimazolam tosylate for sedation in ICU patients: A multicenter, randomized, phase 2 study. J Intensive Med. 2026 Mar 28;6(3):247-254. doi: 10.1016/j.jointm.2026.01.009. eCollection 2026 Jun. | |
| 36920745 |
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This is a Multicenter, Randomized, Single Blind, Dose Finding, Phase II Clinical Trial to explore the optimal dose regimen of Remimazolam Tosilate for Injection for sedation in the ICU, as well as preliminarily evaluate the efficacy and safety of Remimazolam Tosilate for Injection for sedation in the ICU
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| Remimazolam Tosilate | Drug | Loading dose: 0.08mg/kg, Drug: Propofol Injection Maintenance dose: IV remimazolam tosilate, dose range 0-2.0mg/kg/h, increment or decrement of 0.2mg/kg/h IV of Propofol Injection |
|
| Percentage of subjects receiving rescue analgesia and the average dosage of rescue analgesiaassessment time point after drug administering. | within 24 hours after administration of research drug |
| The number of times to change the infusion rate | within 24 hours after administration of research drug |
| Wake-up time. | within 8 hours after stopping the research drug |
| Evaluation of nursing difficulty. | follow-up period (approx. 5-10 minutes) |
| Mechanical ventilation time. | at the time of extubation |
| Liu N, Jiang Z, Nie Y, Zuo L, Chen C, Si X, Liu Q, Chen M, Guan X. Study Protocol of a Multicenter, Randomized, Single-Blind Trial: Efficacy and Safety of Remimazolam Tosylate for Sedation in ICU Patients. Adv Ther. 2023 May;40(5):2524-2533. doi: 10.1007/s12325-023-02456-7. Epub 2023 Mar 15. |