Actively Recruiting
Remimazolam Besylate Versus Propofol for Sedation of Postcardioperative Patients in Intensive Care Unit: A Prospective, Single-center, Randomized Non-inferior Trial
Led by First Affiliated Hospital of Zhejiang University · Updated on 2025-02-18
120
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating sedation methods for patients recovering in intensive care after cardiac surgery who require mechanical ventilation. The study compares two sedative drugs, remimazolam besylate and propofol, to determine which provides effective sedation with fewer side effects and quicker awakening to support earlier breathing tube removal. This trial is a prospective, single-center, randomized study focusing on sedation quality and safety in adults aged 18 and older. Participants are randomly assigned to receive either remimazolam or propofol through intravenous infusion. The remimazolam group starts at 0.2 mg/kg/h, adjustable up to 2 mg/kg/h, while the propofol group starts at 1 mg/kg/h, adjustable up to 4 mg/kg/h. Both aim to maintain a sedation level measured by the Richmond Agitation-Sedation Scale (RASS) between -2 and 0. If the maximum dose is insufficient, dexmedetomidine is added as a rescue sedative. Sedation is targeted until extubation, expected within 48 hours. During the study, participants will be monitored up to 28 days for sedation effectiveness, extubation success, vital signs, ventilator-free days, cognitive function assessed by the Confusion Assessment Method for the ICU (CAM-ICU), length of ICU stay, and mortality. The primary outcome is the percentage of time spent within the target sedation range over two days. Safety and recovery assessments help determine if remimazolam is a suitable sedative option for this patient group.
CONDITIONS
Brief Title
Remimazolam Besylate in Sedation of Postcardioperative Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Admitted to intensive care unit after cardiac surgery with mechanical ventilation
- Expected to be extubated within 48 hours
- Provided informed consent to participate
You will not qualify if you...
- Pregnant or breastfeeding women
- Known or suspected allergy to the study drugs
- History of impaired consciousness or psychiatric illness
- Severe slow heart rate (below 50 beats per minute)
- Low systolic blood pressure (below 90 mmHg) despite treatment
- Advanced atrioventricular block (second or third degree) or left ventricular ejection fraction below 30%
- Participation in another clinical study within the past 3 months
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 - Up to 2 days
Participants receive sedation with either remimazolam besylate or propofol intravenously while in the intensive care unit after cardiac surgery.
Continuous monitoring during sedation in ICU
Duration - Up to 28 days
Participants are monitored for ventilator-free days, cognitive assessment, length of ICU stay, and 28-day mortality after sedation treatment ends.
Assessments at multiple timepoints up to 28 days
Trial Site Locations
Total: 1 location
1
First afflilated hospital of zhejiang university school of medicine
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
Research Team
Y
Yu Wenqiao PhD
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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