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

• Status: Recruiting
• Trial end date: 2023-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wuhan Union Hospital, China
• Treatments: Propofol

Criteria

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.