Comparison of Dexmedetomidine and Remifentanil Infusion During CABG

Dexmedetomidine Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01572454
• Other study ID #: 2012-02-012-001
• Status: Completed
• Phase: N/A
• First received: April 4, 2012
• Last updated: December 24, 2013
• Start date: March 2012
• Est. completion date: December 2012

Study information

• Verified date: December 2013
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Cardiac Arrhythmia
• Coronary Artery Bypass Graft
• Dexmedetomidine
• Hypokalemia
• Remifentanil

Intervention

Drug:
• Dexmedetomidine infusion
Dexmedetomidine infusion 0.2 mcg/kg/hr during anesthetic induction 0.3 - 0.7 mcg/kg/hr during the surgery
• Remifentanil infusion
Remifentanil infusion 0.05 - 0.3 mcg/kg/min during the anesthetic induction and surgery

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	serum potassium concentration	serum potassium concentration at the day before anesthetic induction	at 24 hour before anesthetic induction	Yes
Primary	serum potassium concentration	1 minutes before anesthetic induction (etomidate injection)	1 minutes before anesthetic induction	Yes
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	No
Secondary	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	No
Secondary	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	No