Clinical trial NCT01572454: Comparison of Dexmedetomidine and Remifentanil Infusion During CABG
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Bypass Graft
Hypokalemia
Cardiac Arrhythmia
Dexmedetomidine
Remifentanil
Keywords: coronary artery bypass graft
hypokalemia
cardiac arrhythmia
dexmedetomidine
remifentanil
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2012-04-06
Enrollment: 77
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

Eligibility 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

Primary outcomes:
measure: serum potassium concentration
timeFrame: at 24 hour before anesthetic induction
measure: serum potassium concentration
timeFrame: 1 minutes before anesthetic induction
measure: serum potassium concentration
timeFrame: 20 minutes after start of anesthetic induction
measure: serum potassium concentration
timeFrame: 2 hour after the start of anesthetic induction
measure: serum potassium concentration
timeFrame: 3 hour after start of anesthetic induction
Secondary outcomes:
measure: arterial blood gas analysis results
timeFrame: 24 hour, 1 min before anesthetic induction, 20 min, 2 and 3 hour after the start of anesthetic induction
measure: incidence of hypokalemia
timeFrame: 24 hour, 1 min before anesthetic induction, 20 min, 2 and 3 hour after the start of anesthetic induction
measure: hemodynamic parameters
timeFrame: 24 hour, 1 min before anesthetic induction, 20 min, 2 and 3 hour after the start of anesthetic induction
measure: inotropics, vasopressor requirement
timeFrame: 24 hour, 1 min before anesthetic induction, 20 min, 2 and 3 hour after the start of anesthetic induction
measure: Myocardial injury marker
timeFrame: 2, 24, 48 hour after the end of surgery
measure: Left ventricular function
timeFrame: 72 hour before, during (immediate after grafting), 72 hour after surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Hyun Sung Cho, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Samsung Medical Center
name: Won Ho Kim, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Samsung Medical Center
name: Young Tak Lee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: