Comparison of Dexmedetomidine and Remifentanil Infusion During CABG

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

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.

Study Overview

• Status: Completed
• Conditions: Dexmedetomidine; Coronary Artery Bypass Graft; Hypokalemia; Cardiac Arrhythmia; Remifentanil
• Intervention / Treatment: Drug: Dexmedetomidine infusion; Drug: Remifentanil infusion

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 Type: Interventional
• Enrollment (Actual): 77
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: Remifentanil

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
serum potassium concentration	serum potassium concentration at the day before anesthetic induction	at 24 hour before anesthetic induction
serum potassium concentration	1 minutes before anesthetic induction (etomidate injection)	1 minutes before anesthetic induction
serum potassium concentration	serum potassium concentration 20 minutes after start of anesthetic induction (at the end of anesthetic induction)	20 minutes after start of anesthetic induction
serum potassium concentration	serum potassium concentration at 2 hour after anesthetic induction (after mammary artery dissection and graft formation)	2 hour after the start of anesthetic induction
serum potassium concentration	serum potassium concentration at 3 hour after end of anesthetic induction (after the anastomosis of coronary graft)	3 hour after start of anesthetic induction

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
arterial blood gas analysis results	arterial blood gas analysis results	24 hour, 1 min before anesthetic induction, 20 min, 2 and 3 hour after the start of anesthetic induction
incidence of hypokalemia	incidence of hypokalemia (serum K < 3.5) incidence of hypokalemia (serum K < 4.5)	24 hour, 1 min before anesthetic induction, 20 min, 2 and 3 hour after the start of anesthetic induction
hemodynamic parameters	hemodynamic parameters (blood pressure, heart rate, central venous pressure, cardiac output, SvO2)	24 hour, 1 min before anesthetic induction, 20 min, 2 and 3 hour after the start of anesthetic induction
inotropics, vasopressor requirement	inotropics, vasopressor requirement	24 hour, 1 min before anesthetic induction, 20 min, 2 and 3 hour after the start of anesthetic induction
Myocardial injury marker	serum concentration of CK-MB, Troponin (i)as a marker for myocaridial injury	2, 24, 48 hour after the end of surgery
Left ventricular function	left ventricular function determined by Tei index, ejection fraction of preoperative, intraoperative, postoperative echocardiography	72 hour before, during (immediate after grafting), 72 hour after surgery

Collaborators and Investigators

• Sponsor: Samsung Medical Center
• Investigators: Principal Investigator: Hyun Sung Cho, MD, PhD, Samsung Medical Center; Principal Investigator: Young Tak Lee, MD, PhD, Samsung Medical Center

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: April 4, 2012
• First Submitted That Met QC Criteria: April 4, 2012
• First Posted (Estimate): April 6, 2012

Study Record Updates

• Last Update Posted (Estimate): December 25, 2013
• Last Update Submitted That Met QC Criteria: December 24, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: dexmedetomidine; coronary artery bypass graft; hypokalemia; remifentanil; cardiac arrhythmia
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Metabolic Diseases; Nutrition Disorders; Deficiency Diseases; Malnutrition; Water-Electrolyte Imbalance; Arrhythmias, Cardiac; Hypokalemia; Potassium Deficiency; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Analgesics, Opioid; Narcotics; Hypnotics and Sedatives; Remifentanil; Dexmedetomidine
• Other Study ID Numbers: 2012-02-012-001