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NOT YET RECRUITING
NCT07880548
PHASE3

Remimazolam vs Propofol for Long-Term Sedation in Mechanically Ventilated ICU Patients

Sponsor: Sun Yat-sen University

View on ClinicalTrials.gov

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

DRUG

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.

DRUG

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