A Study of Remimazolam Tosilate for Sedation in the ICU

Summary

The purpose of this study is to evaluate the efficacy and safety of Remimazolam Tosilate for Injection for sedation in the ICU.

Timeline

Start

2024-03-12

Primary completion

2024-08-13

Completion

2024-09-24

Outcome

Met primary endpoint

paper Sedation success rate was 98.1% with remimazolam tosylate and 96.2% with propofol (difference, 1.9%; 95% CI, -3.3 to 7.8%) PMID 41855428 ↗

paper CONCLUSIONS: Remimazolam tosylate demonstrated noninferior efficacy and good tolerability compared with propofol for short-term sedation in postoperative mechanically ventilated intensive care unit patients. PMID 41855428 ↗

Publications

• 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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Propofol	Small molecule	0.3 mg/kg	Intravenous
Comparator	Propofol	Small molecule	4 mg/kg	Intravenous
Subject	Remimazolam	Small molecule	0 mg/kg	Intravenous
Subject	Remimazolam	Small molecule	2 mg/kg	Intravenous

Indications

No indication recorded.