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

Phase 2

Completed

• Conditions: Critical Illness
• Interventions: Drug: Sedation drugs

• Registration Number: NCT04790734
• Lead Sponsor: Wuhan Union Hospital, China

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.

Study Timeline

• Study First Submitted: 2021-03-08
• Study First Submitted QC: 2021-03-09
• Study First Posted: 2021-03-10
• Study Start: 2021-05-10
• Primary Completion: 2022-04-12
• Study Completion: 2022-05-12
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-12
• Last Update Posted: 2022-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Remimazolam	Sedation drugs	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.
Propofol	Sedation drugs	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.

Primary Outcome Measures

Name	Time	Method
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	The percentage of time in the target sedation range without rescue sedation

Secondary Outcome Measures

Name	Time	Method
Length of ICU stay	From start of study to 28 days	Length of ICU stay
28-day mortality	From start of study to 28 days	28-day mortality
7-day ventitlator free time	From start of study to 7 days	7-day ventitlator free time

Trial Locations

Locations (1)

Department of Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology; 🇨🇳 Wuhan, China