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NCT Number: NCT01572454

Comparison of Dexmedetomidine and Remifentanil Infusion During CABG

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.

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Key information

Conditions

Coronary Artery Bypass Graft Arrhythmias, Cardiac Cardiac Arrhythmia Cardiovascular Diseases Dexmedetomidine Heart Diseases Hypokalemia Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Remifentanil Water-Electrolyte Imbalance

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Samsung Medical Center

Seoul, 135-710, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Dexmedetomidine infusion

Drug

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

Other names: Dexmedetomidine

Remifentanil infusion

Drug

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

Other names: Remifentanil

Primary outcomes

  1. serum potassium concentration

    Time frame: at 24 hour before anesthetic induction

    serum potassium concentration at the day before anesthetic induction

  2. serum potassium concentration

    Time frame: 1 minutes before anesthetic induction

    1 minutes before anesthetic induction (etomidate injection)

  3. serum potassium concentration

    Time frame: 20 minutes after start of anesthetic induction

    serum potassium concentration 20 minutes after start of anesthetic induction (at the end of anesthetic induction)

  4. serum potassium concentration

    Time frame: 2 hour after the start of anesthetic induction

    serum potassium concentration at 2 hour after anesthetic induction (after mammary artery dissection and graft formation)

  5. serum potassium concentration

    Time frame: 3 hour after start of anesthetic induction

    serum potassium concentration at 3 hour after end of anesthetic induction (after the anastomosis of coronary graft)

Secondary outcomes

  1. arterial blood gas analysis results

    Time frame: 24 hour, 1 min before anesthetic induction, 20 min, 2 and 3 hour after the start of anesthetic induction

    arterial blood gas analysis results

  2. incidence of hypokalemia

    Time frame: 24 hour, 1 min before anesthetic induction, 20 min, 2 and 3 hour after the start of anesthetic induction

    incidence of hypokalemia (serum K < 3.5) incidence of hypokalemia (serum K < 4.5)

  3. hemodynamic parameters

    Time frame: 24 hour, 1 min before anesthetic induction, 20 min, 2 and 3 hour after the start of anesthetic induction

    hemodynamic parameters (blood pressure, heart rate, central venous pressure, cardiac output, SvO2)

  4. inotropics, vasopressor requirement

    Time frame: 24 hour, 1 min before anesthetic induction, 20 min, 2 and 3 hour after the start of anesthetic induction

    inotropics, vasopressor requirement

  5. Myocardial injury marker

    Time frame: 2, 24, 48 hour after the end of surgery

    serum concentration of CK-MB, Troponin (i)as a marker for myocaridial injury

  6. Left ventricular function

    Time frame: 72 hour before, during (immediate after grafting), 72 hour after surgery

    left ventricular function determined by Tei index, ejection fraction of preoperative, intraoperative, postoperative echocardiography

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study title

The Comparison of Serum Potassium Concentration, Antiarrhythmic Effect, and Myocardial Protective Effect Between Dexmedetomidine and Remifentanil Infusion in Patients Undergoing Coronary Artery Bypass Surgery

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Apr 6, 2012
Registry last updated
Dec 25, 2013

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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