Remimazolam sedation in ICU patients on mechanical ventilation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-center, prospective, randomized controlled pilot study in ICU patients who require mechanical ventilation and sedation. Participants will be assigned to receive remimazolam or an alternative sedative (such as propofol) to reach a target RASS between 0 and -3. The goal is to observe effects on outcomes relevant to ventilation and recovery, with safety and tolerability monitored throughout the course of sedation and withdrawal. The trial aims to generate preliminary data to inform larger studies on sedation strategies in this population.

Why it matters

Who can join: the full rules

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

Where it's running

• Zhongda Hospital
  Nanjing, Jiangsu, China Recruiting

Study contacts

• Study coordinator: Jingyuan Xu, M.D.
• Email: xujingyuanmail@163.com
• Phone: 00862583262500

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.