Dexmedetomidine and Myocardial Protection

Not Applicable

Active, not recruiting

• Conditions: Cardiopulmonary Bypass; Cardiac Surgery
• Interventions: Drug: Control; Drug: Dexmedetomidine

• Registration Number: NCT04871308
• Lead Sponsor: Seoul National University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-05-03
• Study First Submitted QC: 2021-05-03
• Study First Posted: 2021-05-04
• Study Start: 2021-07-07
• Primary Completion: 2024-12-30
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-01
• Last Update Posted: 2025-04-04
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 224

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Control	Placebo group using normal saline infusion
Dexmedetomidine	Dexmedetomidine	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.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of