Comparison of Dexmedetomidine and Remifentanil Infusion During CABG

Not Applicable

Completed

• Conditions: Coronary Artery Bypass Graft; Hypokalemia; Cardiac Arrhythmia; Dexmedetomidine; Remifentanil
• Interventions: Drug: Dexmedetomidine infusion; Drug: Remifentanil infusion

• Registration Number: NCT01572454
• Lead Sponsor: Samsung Medical Center

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.

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 Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-04-04
• Study First Submitted QC: 2012-04-04
• Study First Posted: 2012-04-06
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-24
• Last Update Posted: 2013-12-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 77

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dexmedetomidine group	Dexmedetomidine infusion	Dexmedetomidine infusion 0.2 mcg/kg/hr during anesthetic induction 0.3 - 0.7 mcg/kg/hr during the surgery
Remifentanil group	Remifentanil infusion	Remifentanil infusion 0.05 - 0.3 mcg/kg/min during the anesthetic induction and surgery

Primary Outcome Measures

Name	Time	Method
serum potassium concentration	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

Name	Time	Method
arterial blood gas analysis results	24 hour, 1 min before anesthetic induction, 20 min, 2 and 3 hour after the start of anesthetic induction	arterial blood gas analysis results
incidence of hypokalemia	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)
hemodynamic parameters	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)
inotropics, vasopressor requirement	24 hour, 1 min before anesthetic induction, 20 min, 2 and 3 hour after the start of anesthetic induction	inotropics, vasopressor requirement
Myocardial injury marker	2, 24, 48 hour after the end of surgery	serum concentration of CK-MB, Troponin (i)as a marker for myocaridial injury
Left ventricular function	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

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of