Dexmedetomidine and Myocardial Protection

NCT ID: NCT04871308

Last Updated: 2026-01-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

224 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-07

Study Completion Date

2025-01-07

Brief Summary

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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

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Conditions

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Cardiac Surgery Cardiopulmonary Bypass

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Control

Placebo group using normal saline infusion

Group Type PLACEBO_COMPARATOR

Control

Intervention Type DRUG

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

Group Type ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type 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.

Interventions

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Dexmedetomidine

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.

Intervention Type DRUG

Control

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

Intervention Type DRUG

Other Intervention Names

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Precedex

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Karam Nam, MD

Clinical Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Karam Nam, M.D.

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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DEXCARD

Identifier Type: -

Identifier Source: org_study_id

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