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OpenTrials
Completed

NCT Number: NCT04871308

Dexmedetomidine and Myocardial Protection

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.

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, 03080, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexmedetomidine

Drug

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.

Other names: Precedex

Control

Drug

During the same time window for dexmedetomidine, normal saline is infused at the same rate calculated for dexmedetomidine.

Primary outcomes

  1. cardiac troponin I

    Time frame: Three days after surgery

    Area under the curve of cardiac troponin I measured at 0, 6, 24, 48, 72 hours after surgery

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

Cardioprotective Effect of Dexmedetomidine in Patients Undergoing Cardiac Surgery With Cardiopulmonary Bypass: a Randomized, Placebo-controlled Trial

Acronym: DEXCARD

Important dates

Study start
2021
Primary completion
2024
Study completion
2025
First posted
May 4, 2021
Registry last updated
Jan 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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