Step 2 of A Two-step Trial to Evaluate the Effectiveness and Safety of Remimazolam Besylate for Sedation in ICU Patients

Phase 3 Completed 164 enrolled Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Yichang Humanwell Pharmaceutical Co., Ltd., China · collab

RandomizedParallel-groupSingle-blindTreatment

Summary

A randomized non-inferior trial comparing remimazolam besylate with propofol for short-term sedation during invasive mechanical ventilation in intensive care units

Timeline

Start: 2023-02-28
Primary completion: 2023-11-25
Completion: 2023-11-25

Publications

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.
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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Propofol	Small molecule	0.3 mg/kg	Intravenous
Subject	Remimazolam	Small molecule	0.2 mg/kg	Intravenous
Background	Remifentanil	Small molecule	1.5 ug/kg	—
Background	Remifentanil	Small molecule	12 ug/kg	—

Indications

No indication recorded.