Ireland
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Recruiting Phase 3

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

NCT07596589 · tracked via the Priya Life Science China tracker
Phase
Phase 3
Started
2025-04-01
Last updated
2026-05-19

Condition(s) studied

Remimazolam BesylateMechanically Ventilated ICU PatientsSedation

Investigational drug(s) / intervention(s)

Remimazolam →propofol →

Remimazolam: In the intervention group, patients with a Richmond Agitation-Sedation Scale (RASS) score of -3 to 0 were given remimazolam besylate for injection at a loading dose of 0.08 mg/kg infused intravenously over 10 min, followed by a continuous infusion at a rate of 0.2 mg/kg/h. When dose adjustment was required, each step was 0.1-0.2 mg/kg/h, with a dose range of 0-2 mg/kg/h, until the target sedation level (RASS: -3 to 0) was achieved. If the target sedation level was not reached, an additional bolus dose of 0.08 mg/kg remimazolam besylate could be administered.

propofol: In the control group, patients received propofol emulsion injection at a loading dose of 0.3 mg/kg/h injected over 1 min, followed by a continuous infusion at a rate of 0.3 mg/kg/h. Dose adjustments were made in increments of 0.3-0.6 mg/kg/h, within a dose range of 0.3-4 mg/kg/h, to achieve the target sedation level (RASS: -3 to 0).

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • 28-day ventilator-free days — 28-day

Trial sites (1)

FacilityCityRegionStatus
Zhongda Hospital Nanjing Jiangsu Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07596589 on ClinicalTrials.gov ↗ ← All trials in China