Actively Recruiting
Remimazolam Besylate in Sedation of Postcardioperative Patients
Led by First Affiliated Hospital of Zhejiang University · Updated on 2025-02-18
120
Participants Needed
1
Research Sites
15 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Intensive care medicine is vital in managing patients after cardiac surgery with endotracheal intubation，in order to provide extensive monitoring to assure clinical stabilization. During this time of recovery, sedation is frequently employed. However, prolonged sedation risks negative sequelae.At present,propofol, benzodiazepines, and dexmedetomidine are typical drugs used for sedation of patients in intensive care unit.Each has its own advantages and disadvantages.The investigators try to find near-ideal agents for sedation,characterized by good sedative effect,minimal adverse effects and rapid awakening facilitating earlier extubation.Remimazolam appeared to be an effective and safe sedative for short term sedation. Study participants were predicated on age (\> 18 years), admission following cardiac surgery, still mechanical ventilation within 48 hours,and prior informed consent.Participants were randomized to receive remimazolam besylate or propofol in a 1:1 ratio for sedation with a target sedation depth before extubation.Finally，the investigators will compare the sedation effect and safety between the 2 groups ，to prove if remimazolam is appropriate for sedation in patients after cardiac surgery in intensive care unit.
CONDITIONS
Official 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 lactating women
- Known or suspected allergy to the study drugs
- History of impaired consciousness or psychiatric illness
- Severe bradycardia with heart rate below 50 beats per minute
- Low systolic blood pressure below 90 mmHg despite fluid resuscitation and vasopressor use
- Second or third degree atrioventricular block or left ventricular ejection fraction below 30%
- Participation in other clinical studies within the past 3 months
AI-Screening
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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
CONTACT
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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