Remimazolam Besylate and Propofol Sedation on Hemodynamic for Coronary Artery Bypass Graft Patients

Comparison of the Effects of Remimazolam Besylate and Propofol Sedation on Hemodynamic for Coronary Artery Bypass Graft Patients：a Prospective, Single Blinded, Randomized Controlled Trial

In the immediate postoperative period following cardiac surgery, many patients require short-term sedation until cardiovascular and respiratory stability has been achieved and weaning from artificial ventilation can be started. For these patients, current guideline recommended propofol over benzodiazepine, mainly because of the short elimination half life of propofol. However, hypotension, a very common side effect of propofol, may impose restrictions on its use in some cardiac surgery patients. Remimazolam besylate is a novel, ultra-short-acting benzodiazepine that undergoes organ-independent metabolism by tissue esterases into an inactive metabolite. In other words, remimazolam has both the property of quick offset of effect like propofol and the stable hemodynamic effect like midazolam, making it favorable for use as a sedative in cardiac surgery patients. The aim of this study is to evaluate the hemodynamic effect of remimazolam besylate versus propofol in patients undergoing cardiac surgery.

Study Overview

• Status: Not yet recruiting
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Drug: Remimazolam; Drug: Propofol

• Study Type: Interventional
• Enrollment (Estimated): 338
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Guang-wei Hao; Phone Number: 02164041990; Email: hao.guangwei@zs-hospital.sh.cn
• Study Contact Backup: Name: Guo-wei Tu; Phone Number: 13501996995; Email: tu.guowei@zs-hospital.sh.cn

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Zhongshan Hospital Fudan University
      • Contact: Guang-wei Hao; Phone Number: 02164041990; Email: hao.guangwei@zs-hospital.sh.cn
      • Contact: Guo-wei Tu; Phone Number: 02164041990; Email: tu.guowei@zs-hospital.sh.cn
      • Principal Investigator: Zhe Luo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Sign the informed consent form voluntarily and follow the plan requirements;
• age over 60 years old;
• post coronary artery bypass surgery;
• anticipated mechanical ventilation duration >8 hours
• admission to the cardiac surgery intensive care unit of Zhongshan hospital, Fudan University

Exclusion Criteria:

• delirium before surgery
• severe cognitive dysfunction before surgery
• patients with over degree II A-V block or consistent bradycardia
• patients who are still not awake 12 hours after surgery
• patients who are agitated or cannot follow command
• patients with mechanical circulatory support (ECMO, IABP)
• patients who are allergy to propofol or remimazolam
• BMI≥30kg/m2
• patients with much drainage, the surgery ask for blood pressure control or reopen the chest

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: propofol	Drug: Propofol; Intravenous pump injection. The loading dose will be 0.5mg/kg, the maintenance dose will be 1-4mg/kg/h, with the target RASS be -2-0
Experimental: remimazolam	Drug: Remimazolam; Intravenous pump injection. The loading dose will be 0.1mg/kg, the maintenance dose will be 0.1-0.5mg/kg/h, with the target RASS be -2-0

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
rate of hypotension during infusion of remimazolam or propofol in patients undergoing coronary artery bypass surgery	Within 8 hours of study drug used

Secondary Outcome Measures

Outcome Measure	Time Frame
RASS score during infusion of remimazolam or propofol in patients undergoing coronary artery bypass surgery	Within 8 hours of study drug used

Other Outcome Measures

Outcome Measure	Time Frame
rate of delirium during infusion of remimazolam or propofol in patients undergoing coronary artery bypass surgery	Within 8 hours of study drug used

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital
• Investigators: Principal Investigator: Zhe Luo, Fudan University

Study record dates

Study Major Dates

• Study Start (Estimated): July 15, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: July 3, 2024
• First Submitted That Met QC Criteria: July 3, 2024
• First Posted (Actual): July 11, 2024

Study Record Updates

• Last Update Posted (Actual): July 11, 2024
• Last Update Submitted That Met QC Criteria: July 3, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Hypnotics and Sedatives; Propofol
• Other Study ID Numbers: REMAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No