Cardiac Surgery, Cardiopulmonary Bypass
Conditions
Brief summary
Dexmedetomidine, an alpha-2 agonist, is a sedative that is widely used in various clinical settings because, compared to benzodiazepines, it preserves respiratory function better and its duration of action is short. Recent experimental studies showed a possibility that dexmedetomidine may have an organoprotective effect from ischemic-reperfusion injury by reducing inflammatory response. Besides, dexmedetomidine is known to be related with attenuated sympathetic tone and improved microcirculation. Taken together, it is plausible that dexmedetomidine exerts cardioprotection in patients undergoing cardiac surgery with cardiopulmonary bypass and aortic cross-clamp. The aim of this trial is to test the effect of dexmedetomidine on postoperative cardiac troponin I measurements in patients undergoing cardiac surgery.
Interventions
DRUGDexmedetomidine
Anesthesia is induced using midazolam or etomidate, and sufentanil. A target-controlled infusion of propofol and remifentanil is used for anesthesia maintenance. From anesthesia induction before the initiation of cardiopulmonary bypass, dexmedetomidine is infused intravenously at a rate of 0.5 mcg/kg/hr after a loading dose infusion of 0.75 mcg/kg for 10 mins.
DRUGControl
During the same time window for dexmedetomidine, normal saline is infused at the same rate calculated for dexmedetomidine.
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* cardiac surgery utilizing cardiopulmonary bypass and aortic cross-clamp
Exclusion criteria
* Coronary artery bypass grafting * Concomitant cryo-Maze procedure * Myectomy * Heart transplantation * Concomitant major non-cardiac surgery * Isolated complicated congenital heart surgery * descending thoracic aorta surgery with partial cardiopulmonary bypass * Emergency surgery * Minimally invasive or robot-assisted surgery * Estimated GFR \<30 ml/min/1.73 m2 * Documented end-stage renal disease * Preoperative renal replacement therapy * Preoperative history of percutaneous coronary intervention within 6 month before surgery * Acute coronary syndrome within 4 weeks before surgery * Preoperative mechanical circulatory support devices
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| cardiac troponin I | Three days after surgery | Area under the curve of cardiac troponin I measured at 0, 6, 24, 48, 72 hours after surgery |
Countries
South Korea
Contacts
PRINCIPAL_INVESTIGATORKaram Nam, M.D.
Seoul National University Hospital
Outcome results
None listed