NCT04871308

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
224

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 3, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 4, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

July 7, 2021

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2024

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 7, 2025

Completed
Last Updated

January 30, 2026

Status Verified

January 1, 2026

Enrollment Period

3.5 years

First QC Date

May 3, 2021

Last Update Submit

January 28, 2026

Conditions

Cardiac SurgeryCardiopulmonary Bypass

Outcome Measures

Primary Outcomes (1)

  • cardiac troponin I

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

    Three days after surgery

Study Arms (2)

Control

PLACEBO COMPARATOR

Placebo group using normal saline infusion

Drug: Control

Dexmedetomidine

ACTIVE COMPARATOR

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

DexmedetomidineDRUG

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
Dexmedetomidine
ControlDRUG

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

Control

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • cardiac surgery utilizing cardiopulmonary bypass and aortic cross-clamp

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

MeSH Terms

Interventions

Dexmedetomidine

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Karam Nam, M.D.

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Assistant Professor

Study Record Dates

First Submitted

May 3, 2021

First Posted

May 4, 2021

Study Start

July 7, 2021

Primary Completion

December 30, 2024

Study Completion

January 7, 2025

Last Updated

January 30, 2026

Record last verified: 2026-01

Locations

KR(1)