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CompletedNCT04871308DEXCARDUpdated Jan 30, 2026

Dexmedetomidine and Myocardial Protection

An interventional study of Dexmedetomidine and Control in Cardiac Surgery and Cardiopulmonary Bypass, sponsored by Seoul National University Hospital. Completed at 1 site in South Korea. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-01-30.

Sponsored by Seoul National University Hospital · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
224
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Cardiac Surgery
  • Cardiopulmonary Bypass
03

In context

Lead sponsor

Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • cardiac surgery utilizing cardiopulmonary bypass and aortic cross-clamp

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
224 participants (actual)

Study arms

  • Placebo comparator
    Control

    Placebo group using normal saline infusion

    Drug: Control

  • Active comparator
    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.

    Drug: Dexmedetomidine

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.

    Also known as: Precedex

  • DrugControl

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

06

What researchers measure

Primary outcomes

  1. cardiac troponin I

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

    Time frame: Three days after surgery

07

Study locations

1 site
  • Seoul National University Hospital
    Seoul, 03080, South Korea
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 30, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04871308
Lead sponsor
Seoul National University Hospital
Responsible party
Karam Nam, MD (Clinical Assistant Professor, Seoul National University Hospital) — Principal investigator
First posted
May 4, 2021
Start date
Jul 7, 2021
Primary completion
Dec 30, 2024
Completion
Jan 7, 2025
Last update
Jan 30, 2026

Study contacts

Karam Nam, M.D.
principal investigator · Seoul National University Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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