Comparison of Dexmedetomidine and Remifentanil Infusion During CABG

Study Description

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Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Coronary Artery Bypass Graft; Hypokalemia; Cardiac Arrhythmia; Dexmedetomidine; Remifentanil	Drug: Dexmedetomidine infusion; Drug: Remifentanil infusion	Not Applicable

Detailed Description:

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	77 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Participant)
Official 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
Study Start Date :	March 2012
Actual Primary Completion Date :	December 2012
Actual Study Completion Date :	December 2012

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: Dexmedetomidine group; Dexmedetomidine infusion 0.2 mcg/kg/hr during anesthetic induction 0.3 - 0.7 mcg/kg/hr during the surgery	Drug: Dexmedetomidine infusion; Dexmedetomidine infusion 0.2 mcg/kg/hr during anesthetic induction 0.3 - 0.7 mcg/kg/hr during the surgery; Other Name: Dexmedetomidine
Active Comparator: Remifentanil group; Remifentanil infusion 0.05 - 0.3 mcg/kg/min during the anesthetic induction and surgery	Drug: Remifentanil infusion; Remifentanil infusion 0.05 - 0.3 mcg/kg/min during the anesthetic induction and surgery; Other Name: Remifentanil

Outcome Measures

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Primary Outcome Measures :

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 Outcome Measures :

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

Eligibility Criteria

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Ages Eligible for Study:	20 Years to 70 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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Locations

Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 135-710

Sponsors and Collaborators

Samsung Medical Center

Investigators

Principal Investigator:	Hyun Sung Cho, MD, PhD	Samsung Medical Center
Principal Investigator:	Won Ho Kim, MD	Samsung Medical Center
Principal Investigator:	Young Tak Lee, MD, PhD	Samsung Medical Center

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Hyun Sung Cho, Professor, Samsung Medical Center
ClinicalTrials.gov Identifier:	NCT01572454 History of Changes
Other Study ID Numbers:	2012-02-012-001
First Posted:	April 6, 2012
Last Update Posted:	December 25, 2013
Last Verified:	December 2013

Keywords provided by Hyun Sung Cho, Samsung Medical Center:

coronary artery bypass graft; hypokalemia; cardiac arrhythmia; dexmedetomidine; remifentanil

Additional relevant MeSH terms:

Arrhythmias, Cardiac; Hypokalemia; Potassium Deficiency; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Water-Electrolyte Imbalance; Metabolic Diseases; Deficiency Diseases; Malnutrition; Nutrition Disorders; Anesthetics; Remifentanil; Dexmedetomidine; Central Nervous System Depressants	Physiological Effects of Drugs; Hypnotics and Sedatives; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Analgesics, Opioid; Narcotics; Anesthetics, Intravenous