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Comparison of Dexmedetomidine and Remifentanil Infusion During CABG

NCT ID: NCT01572454

Last Updated: 2013-12-25

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

77 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2012-12-31

Brief Summary

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We are trying to investigate whether intraoperative dexmedetomidine infusion could decrease the incidence of intraoperative hypokalemia and arrhythmia, and myocardial injury in patients undergoing off-pump coronary artery bypass graft, and trying compare these effects with those of remifentanil infusion.

Detailed Description

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Alpha2-adrenergic agonist, dexmedetomidine, is recently used for sedation, analgesia or adjuvant to general anesthesia. Postsynaptic activation of alpha2 adrenoceptors in the central nervous system (CNS) inhibits sympathetic activity and thus can decrease blood pressure and heart rate. The blockade of sympathetic activity decrease the neuroendocrine stress response and may decrease the incidence of hypokalemia. The hypokalemia can increase the incidence of arrythmia, especially in cardiac patients. We postulated that dexmedetomidine could decrease the neuroendocrine stress response, thus decrease arrhythmia during cardiac surgery. Furthermore, dexmedetomidine have been reported to have cardioprotective effect with previous animal studies.

Therefore, the aim of the present study is to investigate whether the intraoperative dexmedetomidine infusion can reduce the incidence of hypokalemia and arrythmia, and myocardial injury in subjects undergoing off-pump coronary artery bypass graft. We are also trying to compare these effects with those of remifentanil infusion.

Conditions

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Coronary Artery Bypass Graft Hypokalemia Cardiac Arrhythmia Dexmedetomidine Remifentanil

Keywords

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coronary artery bypass graft hypokalemia cardiac arrhythmia dexmedetomidine remifentanil

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Participants

Study Groups

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Dexmedetomidine group

Dexmedetomidine infusion 0.2 mcg/kg/hr during anesthetic induction 0.3 - 0.7 mcg/kg/hr during the surgery

Group Type EXPERIMENTAL

Dexmedetomidine infusion

Intervention Type DRUG

Dexmedetomidine infusion 0.2 mcg/kg/hr during anesthetic induction 0.3 - 0.7 mcg/kg/hr during the surgery

Remifentanil group

Remifentanil infusion 0.05 - 0.3 mcg/kg/min during the anesthetic induction and surgery

Group Type ACTIVE_COMPARATOR

Remifentanil infusion

Intervention Type DRUG

Remifentanil infusion 0.05 - 0.3 mcg/kg/min during the anesthetic induction and surgery

Interventions

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Dexmedetomidine infusion

Dexmedetomidine infusion 0.2 mcg/kg/hr during anesthetic induction 0.3 - 0.7 mcg/kg/hr during the surgery

Intervention Type DRUG

Remifentanil infusion

Remifentanil infusion 0.05 - 0.3 mcg/kg/min during the anesthetic induction and surgery

Intervention Type DRUG

Other Intervention Names

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Dexmedetomidine Remifentanil

Eligibility Criteria

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Inclusion Criteria

* Those undergoing off-pump coronary artery bypass graft during March, 2012 \~ February, 2013 in Samsung Medical Center
* Age between 20 and 70 yrs old

Exclusion Criteria

* Any patients with plasma aldosterone, or glucocorticoid disorder including primary hyperaldosteronism, renovascular hypertension, rennin-secreting tumor, salt-wasting renal disease, Cushing syndrome
* Patients with recent exogenous steroid administration or previous diuretics therapy
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Hyun Sung Cho

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hyun Sung Cho, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Won Ho Kim, MD

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Young Tak Lee, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Locations

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Samsung Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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2012-02-012-001

Identifier Type: -

Identifier Source: org_study_id