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| Name | Class |
|---|---|
| Yichang Humanwell Pharmaceutical Co., Ltd., China | INDUSTRY |
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A randomized non-inferior trial comparing remimazolam besylate with propofol for short-term sedation during invasive mechanical ventilation in intensive care units
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Remimazolam besylate | Experimental | Remimazolam besylate |
|
| Propofol | Active Comparator | Propofol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remimazolam besylate | Drug | 0~2.0mg/kg/h |
| |
| Propofol |
| Measure | Description | Time Frame |
|---|---|---|
| Successful sedation | 70% of time in the target sedation range in participants without rescue sedation | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| The percentage of time in the target sedation range without rescue sedation | The percentage of time in the target sedation range without rescue sedation | 24 hours |
| Number of patients needing rescue sedation |
| Measure | Description | Time Frame |
|---|---|---|
| Hypotension | Whether hypotension occurs in participants | 24 hours |
| Delirium | Whether delirium occurs in participants | 24 hours |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wuhan Union Hospital | Wuhan | Hubei | 430022 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41915173 | Derived | Yang X, Pan J, Gong X, Lv A, Liang F, Liu J, Li D, Fu S, Pan A, Yu L, Zhang L, Chen T, Zhan L, Qin B, Lin F, Xiong X, Zhu Y, He Z, Sun R, Sun T, Qian S, Wen D, Zou X, Qi H, Shu H, Song L, Wang C, Shang Y. Short-term light sedation with remimazolam besylate versus propofol in the ICU (SHOSREB): a multicentre, randomized, single-blind, controlled trial. Intensive Care Med. 2026 May;52(5):1001-1011. doi: 10.1007/s00134-026-08381-x. Epub 2026 Mar 31. | |
| 40493335 |
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| Drug |
0.3~4.0mg/kg/h |
|
| Remifentanil | Drug | 1.5~12μg/kg/h |
|
Whether participants need sedative drugs other than the study drug to re maintain targeted sedation level
| 24 hours |
| Number of patients needing repeated boluses of the study drug | Whether participants need repeated boluses of the study durg other than the loading dose to maintain targeted sedation level | 24 hours |
| The amount of remifentanil in ug/kg/h | The amount of remifentanil in ug/kg/h used in each patient in both groups | 24 hours |
| Derived |
| Tang Y, Shu H, Ren L, Li R, Zou X, Qi H, Ouyang Y, Wu Y, Xu J, Fang X, Yang X, Shang Y. Remimazolam Besylate Versus Propofol for Short-Term Sedation in Critically Ill Patients Receiving Mechanical Ventilation: Protocol for a Multicenter Randomized Non-inferior Trial. Adv Ther. 2025 Aug;42(8):4081-4088. doi: 10.1007/s12325-025-03268-7. Epub 2025 Jun 10. |
| ID | Term |
|---|---|
| D015742 | Propofol |
| D000077208 | Remifentanil |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011422 | Propionates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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