An interventional study of Dexmedetomidine infusion and Remifentanil infusion in Coronary Artery Bypass Graft, Hypokalemia and Cardiac Arrhythmia, sponsored by Samsung Medical Center. Completed at 1 site in South Korea. Open to participants aged 20 Years to 70 Years. Per ClinicalTrials.gov, last updated 2013-12-25.
Sponsored by Samsung Medical Center · Not applicable and Interventional
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.
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.
27 studies on the registry are indexed under Hypokalemia; 5 are open to participants now.
This study's enrollment of 77 is close to the median of 77 across 19 interventional studies indexed under Hypokalemia.
Browse Hypokalemia studies →Samsung Medical Center is the lead sponsor of 1,005 studies on the registry; 148 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.
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Exclusion Criteria:
Dexmedetomidine infusion 0.2 mcg/kg/hr during anesthetic induction 0.3 - 0.7 mcg/kg/hr during the surgery
Drug: Dexmedetomidine infusion
Remifentanil infusion 0.05 - 0.3 mcg/kg/min during the anesthetic induction and surgery
Drug: Remifentanil infusion
Dexmedetomidine infusion 0.2 mcg/kg/hr during anesthetic induction 0.3 - 0.7 mcg/kg/hr during the surgery
Also known as: Dexmedetomidine
Remifentanil infusion 0.05 - 0.3 mcg/kg/min during the anesthetic induction and surgery
Also known as: Remifentanil
serum potassium concentration
serum potassium concentration at the day before anesthetic induction
Time frame: at 24 hour before anesthetic induction
serum potassium concentration
1 minutes before anesthetic induction (etomidate injection)
Time frame: 1 minutes before anesthetic induction
serum potassium concentration
serum potassium concentration 20 minutes after start of anesthetic induction (at the end of anesthetic induction)
Time frame: 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)
Time frame: 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)
Time frame: 3 hour after start of anesthetic induction
arterial blood gas analysis results
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
incidence of hypokalemia
incidence of hypokalemia (serum K \< 3.5) incidence of hypokalemia (serum K \< 4.5)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 72 hour before, during (immediate after grafting), 72 hour after surgery
The record gives a start of Mar 2012, a primary completion of Dec 2012 and a completion of Dec 2012. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Dec 2013. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Dexmedetomidine