CompletedPhase 2

Efficacy and Safety of Remimazolam Besylate Versus Propofol for Sedation in Mechanically Ventilated ICU Patients

China60 participantsStarted 2021-05-10

Plain-language summary

The purpose of this study is to evaluate the efficacy and safety of remimazolam compared to propofol for sedation in mechanically ventilated ICU patients.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age ≥ 18 and ≤ 75 years; * Intubated and mechanically ventilated ≤96 hours before enrollment； * Expected to require continuous invasive ventilation and sedation ≥24 hours; * Requirement for light to moderate sedation (a RASS score of -3 to 0). Exclusion Criteria: * Body mass index (BMI) \<18 or \>30 kg/m2; * Acute severe neurological disorder and any other condition interfering with RASS assessment; * Systolic blood pressure less than 90 mm Hg after appropriate intravenous volume replacement and continuous infusions of 2 vasopressors; * Heart rate less than 50 beats/min; * Second- or third-degree heart block in the absence of a pacemaker; * Unstable angina; * Acute myocardial infarction; * Left ventricular ejection fraction less than 30%; * Contraindicate or allergic to study drugs; * Moribund state; * Acute hepatitis or serious hepatic dysfunction (Child-Pugh class C); * Chronic kidney disease with glomerular filtration rate (GFR) \< 60 ml/min/1.73m2; * Alcohol abuse; * Myasthenia gravis; * Pregnancy or lactation.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The percentage of time in the target sedation range without rescue sedation

Timeframe: From the beginning of using study sedatives until being extubated, being discharged from our ICU, the study drug was stopped for 24 hours by physicians, or 7 days after enrollment, whichever came first

Trial details

NCT IDNCT04790734

SponsorUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-04-12

View on ClinicalTrials.gov More Critical Illness trials

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.