Efficacy and Safety of Remimazolam Besylate Versus Propofol for Sedation in Critically Ill Patients With Deep Sedation

Efficacy and Safety of Remimazolam Besylate Versus Propofol for Sedation in Critically Ill Patients With Deep Sedation

The purpose of this study is to evaluate the efficacy and safety of remimazolam besylate compared to propofol for sedation in critically ill patients with deep sedation.

This is a single-center, prospective, randomized, controlled study using remimazolam besylate and propofol for sedation in critically ill patients with deep sedation. 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.

Inclusion Criteria:

• Age ≥ 18 and ≤ 80 years;
• Expected to require deep sedation ≥8 hours;
• Requirement for deep sedation (a Narcotrend index between 13 and 64).

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;
• Expected to have a general anesthesia within 8 hours;
• Pregnancy or lactation.