Effect of Remimazolam Sedation on Outcomes of Mechanically Ventilated Patients in the ICU (NCT07596589) | Clinical Trial Compass
RecruitingPhase 3
Effect of Remimazolam Sedation on Outcomes of Mechanically Ventilated Patients in the ICU
China80 participantsStarted 2025-04-01
Plain-language summary
The goal of this clinical trial is to evaluate the effect of remimazolam sedation on outcomes of mechanically ventilated ICU patients through a single-center, prospective, randomized controlled, pilot study.
Who can participate
Age range
18 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 years;
* Endotracheal intubation and mechanical ventilation for 24-96 hours before enrollment Expected need for continued invasive ventilation and sedation for at least 24 hours;
* Target sedation depth on the Richmond Agitation-Sedation Scale (RASS) between 0 and -3;
* Informed consent obtained from the patient's family
Exclusion Criteria:
* Body mass index (BMI) \> 30 kg/m²
* Severe central nervous system disease (e.g., acute stroke, uncontrolled seizures, or severe dementia) or any other condition that precludes RASS assessment
* Mean arterial pressure (MAP) \< 55 mmHg despite intravenous fluid resuscitation and vasopressors
* Heart rate \< 50 beats per minute, or second-degree or third-degree atrioventricular block in the absence of a pacemaker
* Acute myocardial infarction or severe heart failure (New York Heart Association \[NYHA\] class IV)
* Left ventricular ejection fraction \< 30%
* Any contraindication or allergy to benzodiazepines
* Substance dependence, alcohol abuse, or psychiatric/psychological disorders. Alcohol abuse was defined as regular consumption of \> 14 drinks per week (1 drink = 150 mL wine, 360 mL beer, or 45 mL liquor)
* Acute hepatitis or severe hepatic dysfunction (Child-Pugh class C)
* Chronic kidney disease with a glomerular filtration rate (GFR) \< 60 mL/min/1.73 m²
* Neuromuscular disease
* Patients on extracorporeal membrane oxygenation (ECMO)
* Pregnancy or breastfeeding
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.