Efficacy and Safety of Remimazolam Besylate Versus Propofol for Sedation in Mechanically Ventilated ICU Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Efficacy and Safety of Remimazolam Besylate Versus Propofol for Sedation in Mechanically Ventilated ICU Patients: a Pilot Study

Conditions
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Critical Illness

Intervention / Treatment
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* Drug: Sedation drugs


Participation Criteria
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Eligibility Criteria
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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; 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Remimazolam<br>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. | Drug: Sedation drugs<br>* Different sedation drugs<br>|
| Active Comparator: Propofol<br>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. | Drug: Sedation drugs<br>* Different sedation drugs<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percentage of time in the target sedation range without rescue sedation | The percentage of time in the target sedation range without rescue sedation | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of ICU stay | Length of ICU stay | From start of study to 28 days | 
| 28-day mortality | 28-day mortality | From start of study to 28 days | 
| 7-day ventitlator free time | 7-day ventitlator free time | From start of study to 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Remimazolam besylate, Propofol, Intensive care unit, Mechanical ventilation