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

RecruitingPhase 3

Sponsor: Southeast University, China

Conditions: Remimazolam Besylate, Mechanically Ventilated ICU Patients, Sedation

Interventions: Remimazolam, propofol

Countries: China

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (1)

Nanjing, Jiangsu, China