Coronary Artery Disease
Conditions
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.
Interventions
DRUGRemimazolam
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
DRUGPropofol
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
Sponsors
Shanghai Zhongshan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| 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
| 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
| 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 |
Countries
China
Contacts
Primary ContactGuo-wei Tu
Backup ContactGuang-wei Hao
Outcome results
None listed