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Remimazolam vs Propofol for Long-Term Sedation in Mechanically Ventilated ICU Patients
Sponsor: Sun Yat-sen University
Summary
This multicenter, randomized, controlled, non-inferiority trial is designed to determine whether remimazolam is non-inferior to propofol for prolonged sedation in adult ICU patients requiring mechanical ventilation for ≥48 hours. A total of 274 patients will be enrolled across 21 geographically diverse hospitals in China and allocated in a 1:1 ratio to receive either remimazolam or propofol using centralized, computer-generated block randomization. The primary endpoint is time to successful extubation-defined as extubation without reintubation within 48 hours. Secondary endpoints include quantitative measures of sedation quality (e.g., RASS, time to target sedation), clinically outcomes (e.g., length of ICU stay, 28-day and 90-day all-cause mortality), and comprehensive safety evaluation (e.g., incidence and severity of hypotension, post-sedation delirium).
Official title: Remimazolam Tosylate for Long-Term Sedation in Mechanically Ventilated ICU Patients: A Multicenter, Randomized, Propofol-Controlled, Non-Inferiority Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
274
Start Date
2026-10-20
Completion Date
2028-08-31
Last Updated
2026-10-19
Healthy Volunteers
No
Interventions
Remimazolam group
Remimazolam tosilate injection by IV infusion: loading dose 0.05-0.10 mg/kg over ≥ 1 min, then maintenance starting at 0.2 mg/kg/h, titrated in 0.1-0.2 mg/kg/h to achieve the target depth of sedation RASS -2 to +1; maintenance range 0-2 mg/kg/h; up to 28 days of study drug treatment.
Propofol group
Propofol by IV infusion: loading dose 0.3-0.5 mg/kg over ≥ 1 min, then maintenance starting at 0.3 mg/kg/h, titrated in 0.3-0.6 mg/kg/h to achieve the target depth of sedation RASS -2 to +1; maintenance range 0-4 mg/kg/h; up to 28 days of study drug treatment.
Locations (21)
Dongguan People's Hospital
Dongguan, Guangdong, China
First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
The Third Affiliated Hospital, Southern Medical University
Guangzhou, Guangdong, China
Longgang Central Hospital of Shenzhen
Shenzhen, Guangdong, China
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
The First Affiliated Hospital of Henan University of Science & Technology
Luoyang, Henan, China
Zhengzhou Central Hospital
Zhengzhou, Henan, China
Renmin Hospital of Wuhan University
Wuhan, Hubei, China
Wuhan Third Hospital · Tongren Hospital of Wuhan University
Wuhan, Hubei, China
Affiliated Hospital of Nantong University
Nantong, Jiangsu, China
Wuxi People's Hospital
Wuxi, Jiangsu, China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
Qinghai University Affiliated Hospital
Xining, Qinghai, China
Zibo Central Hospital
Zibo, Shandong, China
Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital
Chengdu, Sichuan, China
The Affiliated Hospital of Southwest Medical University
Luzhou, Sichuan, China
Sichuan Mianyang 404 Hospital
Mianyang, Sichuan, China
Jinhua Municipal Central Hospital
Jinhua, Zhejiang, China
Lishui Central Hospital
Lishui, Zhejiang, China
The First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, China
Peking University People's Hospital
Beijing, China