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

Huazhong University of Science and Technology

Status and phase: Enrolling; Phase 2

Conditions: Critically Ill; Deep Sedation

Treatments: Drug: Remimazolam Besylate; Drug: Propofol

Study type: Interventional

Funder types: Other

Identifiers

NCT05539521

WUHICU202202

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Remimazolam Besylate

Experimental group

Description:

Patients in the remimazolam group received remimazolam besylate at an initial infusion rate of 0.3 mg/kg/h and adjusted to maintain a Narcotrend index between 13 and 64.

Treatment:

Drug: Remimazolam Besylate

Propofol

Active Comparator group

Description:

Patients in the propofol group received propofol at an initial infusion rate of 3.0 mg/kg/h and adjusted to maintain a Narcotrend index between 13 and 64.

Treatment:

Drug: Propofol