Actively Recruiting
Effect of Remimazolam Sedation on Outcomes of Mechanically Ventilated Patients in the ICU
Led by Southeast University, China · Updated on 2026-05-19
80
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of remimazolam sedation compared to propofol in patients who are mechanically ventilated in the intensive care unit (ICU). Mechanical ventilation is a critical support for patients with respiratory failure but can cause discomfort and complications that require sedation. This study aims to assess how remimazolam, a new ultra-short-acting benzodiazepine sedative, impacts outcomes in these ICU patients, given its rapid onset, quick metabolism, and mild cardiorespiratory effects. Participants will be randomly assigned to receive either remimazolam or propofol sedation. Those in the remimazolam group will receive a loading dose followed by a continuous intravenous infusion with dose adjustments to maintain a target sedation level. The propofol group will receive an initial dose followed by continuous infusion with dose adjustments to reach the same sedation target. The study is a single-center, prospective, randomized controlled pilot trial designed to compare these two sedatives in mechanically ventilated ICU patients. During the study, patient sedation levels will be monitored using the Richmond Agitation-Sedation Scale (RASS) to maintain a target sedation depth. Researchers will evaluate outcomes including the number of ventilator-free days within 28 days, incidence of delirium, shock-free days, ICU and hospital length of stay, and mortality at 28 days. The study includes thorough monitoring of vital signs and patient safety to assess the effects of the sedatives over the course of treatment.
CONDITIONS
Brief Title
Effect of Remimazolam Sedation on Outcomes of Mechanically Ventilated Patients in the ICU
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Endotracheal intubation and mechanical ventilation for 24 to 96 hours before enrollment
- Expected need for ongoing invasive ventilation and sedation for at least 24 hours
- Target sedation level on Richmond Agitation-Sedation Scale (RASS) between 0 and -3
- Informed consent obtained from patient's family
You will not qualify if you...
- Body mass index (BMI) greater than 30 kg/m²
- Severe central nervous system diseases such as acute stroke, uncontrolled seizures, or severe dementia
- Mean arterial pressure below 55 mmHg despite fluids and vasopressors
- Heart rate below 50 beats per minute or second- or third-degree atrioventricular block without pacemaker
- Acute myocardial infarction or severe heart failure (NYHA class IV)
- Left ventricular ejection fraction below 30%
- Allergy or contraindication to benzodiazepines
- Substance dependence, alcohol abuse, or psychiatric disorders
- Acute hepatitis or severe liver dysfunction (Child-Pugh class C)
- Chronic kidney disease with glomerular filtration rate below 60 mL/min/1.73 m²
- Neuromuscular disease
- Use of extracorporeal membrane oxygenation (ECMO)
- Pregnancy or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - At least 24 hours of ongoing invasive ventilation and sedation
Participants receive sedation with either remimazolam or propofol to achieve and maintain a target sedation level while mechanically ventilated in the ICU.
Continuous monitoring during treatment period
Duration - Up to 60 days
Participants are observed for outcomes related to sedation, ventilation, ICU and hospital stay, delirium incidence, and mortality up to 60 days after treatment.
Regular visits or assessments during ICU and hospital stay as per routine care
Trial Site Locations
Total: 1 location
1
Zhongda Hospital
Nanjing, Jiangsu, China, 210009
Actively Recruiting
Research Team
J
Jingyuan Xu, M.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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