Efficacy and Safety of Remimazolam Besylate Versus Propofol for Sedation in Mechanically Ventilated ICU Patients: a Pilot Study
Overview
- Phase
- Phase 2
- Intervention
- Sedation drugs
- Conditions
- Critical Illness
- Sponsor
- Wuhan Union Hospital, China
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- The percentage of time in the target sedation range without rescue sedation
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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 group and propofol group in a 1:1 ratio. Remifentanil is administered as the analgesic. Efficacy and safety profiles of remimazolam besylate are to be evaluated.
Investigators
Xiaobo Yang, MD
MD
Wuhan Union Hospital, China
Eligibility Criteria
Inclusion Criteria
- •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 Criteria
- •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;
Arms & Interventions
Propofol
Patients in the propofol group received propofol at an initial infusion rate of 2.0 mg/kg/h and adjusted to maintain a RASS score of -3 to 0.
Intervention: Sedation drugs
Remimazolam
Patients in the remimazolam group received remimazolam besylate at an initial infusion rate of 0.15 mg/kg/h and adjusted to maintain a RASS score of -3 to 0.
Intervention: Sedation drugs
Outcomes
Primary Outcomes
The percentage of time in the target sedation range without rescue sedation
Time Frame: From the beginning of using study sedatives until being extubated, being discharged from our ICU, the study drug was stopped for 24 hours by physicians, or 7 days after enrollment, whichever came first
The percentage of time in the target sedation range without rescue sedation
Secondary Outcomes
- Length of ICU stay(From start of study to 28 days)
- 28-day mortality(From start of study to 28 days)
- 7-day ventitlator free time(From start of study to 7 days)