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

NCT ID: NCT05539521

Last Updated: 2022-09-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-05
• Study Completion Date: 2023-03-31

Brief 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.

Detailed 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.

Conditions

Critically Ill; Deep Sedation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Remimazolam Besylate

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.

Group Type: EXPERIMENTAL

Remimazolam Besylate

Intervention Type: DRUG

sedation drugs

Propofol

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.

Group Type: ACTIVE_COMPARATOR

Propofol

Intervention Type: DRUG

Propofol

Interventions

Remimazolam Besylate

sedation drugs

Intervention Type: DRUG

Propofol

Propofol

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

OTHER

Sponsor Role: lead

Responsible Party

Xiaobo Yang, MD

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

You Shang, Professor

Role: PRINCIPAL_INVESTIGATOR

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Locations

Department of Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Xiaobo Yang, MD

Role: CONTACT

want.tofly@aliyun.com

+8602785351606

Facility Contacts

Xiaobo Yang

Role: primary

Other Identifiers

WUHICU202202

Identifier Type: -

Identifier Source: org_study_id