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

Not Applicable

Not yet recruiting

• Conditions: Coronary Artery Disease
• Interventions: Drug: Remimazolam; Drug: Propofol

• Registration Number: NCT06496165
• Lead Sponsor: Shanghai Zhongshan Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-07
• Study First Submitted: 2024-07-03
• Study First Submitted QC: 2024-07-03
• Last Update Submitted: 2024-07-03
• Study First Posted: 2024-07-11
• Last Update Posted: 2024-07-11
• Study Start: 2024-07-15
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 338

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
remimazolam	Remimazolam	-
propofol	Propofol	-

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

Zhongshan Hospital Fudan university; 🇨🇳 Shanghai, Shanghai, China