Effect of Remimazolam Sedation on Outcomes of Mechanically Ventilated Patients in the ICU
Recruiting now · Phase 3
Conditions studied: Remimazolam Besylate, Mechanically Ventilated ICU Patients, Sedation
In brief
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.
Key facts
- Study ID
- NCT07596589
- Run by
- Southeast University, China
- People needed
- 80
- Starts
- 2025-04-01
- Expected to finish
- 2027-01-31
- Last updated by the study team
- 2026-05-19
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Zhongda Hospital — Nanjing, Jiangsu, China (enrolling)
Full record on ClinicalTrials.gov
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