Dexmedetomidine and Myocardial Protection (DEXCARD)

Seoul National University

Status: Completed

Conditions: Cardiac Surgery; Cardiopulmonary Bypass

Treatments: Drug: Control; Drug: Dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT04871308

DEXCARD

Details and patient eligibility

About

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.

Enrollment: 224 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

224 participants in 2 patient groups, including a placebo group

Control

Placebo Comparator group

Description:

Placebo group using normal saline infusion

Treatment:

Drug: Control

Dexmedetomidine

Active Comparator group

Description:

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.

Treatment:

Drug: Dexmedetomidine