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Effect of Remimazolam Sedation on Outcomes of Mechanically Ventilated Patients in the ICU

RecruitingPhase 3Ages 18 Years - anyAllSoutheast University, China
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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
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What it tests

  • Remimazolam
  • propofol
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Where

1 site
Zhongda Hospital
Nanjing, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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