Status:
COMPLETED
Efficacy and Safety of Remimazolam Besylate Versus Propofol for Sedation in Mechanically Ventilated ICU Patients
Lead Sponsor:
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Conditions:
Critical Illness
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of remimazolam compared to propofol for sedation in mechanically ventilated ICU patients.
Detailed Description
This is a single-center, prospective, randomized, controlled pilot study using remimazolam and propofol for sedation in mechanically ventilated ICU patients. Subjects are randomized to remimazolam gro...
Eligibility Criteria
Inclusion
- Age ≥ 18 and ≤ 75 years;
- Intubated and mechanically ventilated ≤96 hours before enrollment；
- Expected to require continuous invasive ventilation and sedation ≥24 hours;
- Requirement for light to moderate sedation (a RASS score of -3 to 0).
Exclusion
- Body mass index (BMI) \<18 or \>30 kg/m2;
- Acute severe neurological disorder and any other condition interfering with RASS assessment;
- Systolic blood pressure less than 90 mm Hg after appropriate intravenous volume replacement and continuous infusions of 2 vasopressors;
- Heart rate less than 50 beats/min;
- Second- or third-degree heart block in the absence of a pacemaker;
- Unstable angina;
- Acute myocardial infarction;
- Left ventricular ejection fraction less than 30%;
- Contraindicate or allergic to study drugs;
- Moribund state;
- Acute hepatitis or serious hepatic dysfunction (Child-Pugh class C);
- Chronic kidney disease with glomerular filtration rate (GFR) \< 60 ml/min/1.73m2;
- Alcohol abuse;
- Myasthenia gravis;
- Pregnancy or lactation.
Key Trial Info
Start Date :
May 10 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 12 2022
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04790734
Start Date
May 10 2021
End Date
May 12 2022
Last Update
September 15 2022
Active Locations (1)
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1
Department of Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, China