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

Fudan University

Status

Not yet enrolling

Conditions

Coronary Artery Disease

Treatments

Drug: Remimazolam

Drug: Propofol

Study type

Interventional

Funder types

Other

Identifiers

NCT06496165

REMAP

Details and patient eligibility

About

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.

Enrollment

338 estimated patients

Sex

All

Ages

60+ years old

Volunteers

No Healthy Volunteers

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