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

NCT07880548 · tracked via the Priya Life Science China tracker

Sponsor

Sun Yat-sen University

Phase

Phase 3

Started

2026-10-20

Last updated

2026-10-21

Condition(s) studied

Long-term Sedation for Mechanical VentilationCritically Ill Intensive Care Unit Patients

Investigational drug(s) / intervention(s)

Remimazolam groupPropofol group

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.

Study 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).

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: 1. Age ≥ 18 years; 2. The interval from ICU admission to the first receipt of mechanical ventilation is no more than 48 h, and the expected total duration of mechanical ventilation is ≥ 48 h; 3. At the time of randomization, more than 24 h of further mechanical ventilation is anticipated; 4. The attending clinician determines that sedation therapy is required; 5. the subject and/or their legal guardian signs the informed consent form (ICF); 6. Women and men of childbearing potential must agree to use highly effective contraception together with their partner and to refrain from donating oocytes or sperm from the time of ICF signing until 28 days after the last dose of study drug. Exclusion Criteria: 1. History of hypersensitivity to benzodiazepines, propofol, remifentanil, or to any of their components or excipients; 2. Severe neurological disease (e.g., myasthenia gravis, severe depression, schizophrenia, severe traumatic brain injury, massive cerebral infarction, status epilepticus, intracranial tumor, post-neurosurgical status); 3. Post-cardiac arrest (with clinician-assessed hypoxic-ischemic brain injury); 4. Subjects who require or are expected to require neuromuscular blocking agents after ICU admission; 5. Pregnant or breastfeeding women; 6. Life expectancy less than 24 hours; 7. Receipt of palliative care; 8. Hospice patients; 9. Severe hepatic impairment (Child-Pugh class C); 10. Participation in another clinical trial of an investigational drug with prior receipt of that drug; 11. Any other condition that, in the investigator's judgment, makes the subject unsuitable for participation in this clinical trial.

Primary outcome measure(s)

Time to successful extubation — From randomization to 28 days after randomization
Successful extubation defined as: (a) intubated patients - spontaneous breathing within 48 h after extubation without need for mechanical ventilatory support; (b) non-invasive ventilation patients - spontaneous breathing with PEEP/CPAP ≤ 5 cmH2O within 48 h; (c) tracheostomized patients - spontaneous breathing with PEEP/CPAP ≤ 5 cmH2O within 48 h.

Trial sites (21)

Facility	City	Region
Dongguan People's Hospital	Dongguan	Guangdong
First Affiliated Hospital, Sun Yat-sen University	Guangzhou	Guangdong
The Third Affiliated Hospital, Southern Medical University	Guangzhou	Guangdong
Longgang Central Hospital of Shenzhen	Shenzhen	Guangdong
The First Affiliated Hospital of Guangxi Medical University	Nanning	Guangxi
The First Affiliated Hospital of Henan University of Science & Technology	Luoyang	Henan
Zhengzhou Central Hospital	Zhengzhou	Henan
Renmin Hospital of Wuhan University	Wuhan	Hubei
Wuhan Third Hospital · Tongren Hospital of Wuhan University	Wuhan	Hubei
Affiliated Hospital of Nantong University	Nantong	Jiangsu
Wuxi People's Hospital	Wuxi	Jiangsu
The Affiliated Hospital of Xuzhou Medical University	Xuzhou	Jiangsu
Qinghai University Affiliated Hospital	Xining	Qinghai
Zibo Central Hospital	Zibo	Shandong
Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital	Chengdu	Sichuan
The Affiliated Hospital of Southwest Medical University	Luzhou	Sichuan
Sichuan Mianyang 404 Hospital	Mianyang	Sichuan
Jinhua Municipal Central Hospital	Jinhua	Zhejiang
Lishui Central Hospital	Lishui	Zhejiang
The First Affiliated Hospital of Ningbo University	Ningbo	Zhejiang
Peking University People's Hospital	Beijing	China

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07880548 on ClinicalTrials.gov ↗ ← All trials in China