Clinical trial NCT06496165: Remimazolam Besylate and Propofol Sedation on Hemodynamic for Coronary Artery Bypass Graft Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Coronary Artery Disease
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2024-07-11
Enrollment: 338
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: rate of hypotension during infusion of remimazolam or propofol in patients undergoing coronary artery bypass surgery
timeFrame: Within 8 hours of study drug used
Secondary outcomes:
measure: RASS score during infusion of remimazolam or propofol in patients undergoing coronary artery bypass surgery
timeFrame: Within 8 hours of study drug used
Other outcomes:
measure: rate of delirium during infusion of remimazolam or propofol in patients undergoing coronary artery bypass surgery
timeFrame: Within 8 hours of study drug used
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital Fudan university
state: Shanghai
Study officials:
affiliation: Fudan University
name: Zhe Luo
role: PRINCIPAL_INVESTIGATOR
References: