Clinical trial NCT01688648: Comparison Between Lidocaine, Dexmedetomidine, and Their Combined Infusion in Subjects Undergoing Coronary Artery Bypass Graft
Official title: The Comparison of Antiarrhythmic and Myocardial Protective Effect Between Lidocaine, Dexmedetomidine, and Their Combined Infusion in Subjects Undergoing Coronary Artery Bypass Graft
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Unstable Angina
Coronary Artery Bypass Graft
Dexmedetomidine
Lidocaine
Myocardial Injury
Arrhythmia
Blood Electrolyte Balance
Keywords: Coronary artery bypass graft
dexmedetomidine
lidocaine
myocardial injury
arrhythmia
blood electrolyte balance
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2012-09-20
Enrollment: 160
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The aim of the present study is to compare the antiarrhythmic and myocardial protective effect between lidocaine, dexmedetomidine, and their combined infusion in subjects undergoing coronary artery bypass graft.

Detailed description: Lidocaine has been reported to have an antiarrhythmic and myocardial protective effect. A previous study has reported that low-dose lidocaine infusion can decrease the incidence of ventricular fibrillation and tachycardia during the first 24 hours after coronary artery bypass graft (CABG). A recent study also reported that the lidocaine infusion during CABG could decrease the myocardial injury by measuring the CK-MB and Troponin-I blood level.

Dexmedetomidine is an alpha-2 agonist and reduces the sympathetic tone and neuroendocrine stress response. Dexmedetomidine was reported to have a cardioprotective effect by a previous animal study. However, there was no clinical study evaluating the cardioprotective effect of dexmedetomidine.

Therefore, we are trying to evaluate and compare the antiarrhythmic and myocardial protective effect between lidocaine, dexmedetomidine, and their combined infusion in subjects undergoing coronary artery bypass graft.

Eligibility criteria: Inclusion Criteria:

* Those undergoing off-pump coronary artery bypass graft during the study period in Samsung Medical Center

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
* Patients with recent myocardial infarction
* Those undergoing unplanned cardiopulmonary bypass during the surgery

Primary outcomes:
measure: Myocardial injury marker
timeFrame: postoperative ICU day 1
measure: Myocardial injury marker
timeFrame: postoperative ICU day 2
measure: Myocardial injury marker
timeFrame: postoperative ICU day 3
Secondary outcomes:
measure: The blood sodium, potassium, calcium level
timeFrame: 1 day before surgery day, at the start of anesthetic induction, 2 hour, 4 hour after anesthetic induction, postoperative ICU day 1, 2, 3
measure: The incidence of arrhythmia during and after the surgery
timeFrame: 1 day before surgery day, at the start of anesthetic induction, 2 hour, 4 hour after anesthetic induction, postoperative ICU day 1, 2, 3
measure: Postoperative ICU stay, Hospital stay, Extubation time
timeFrame: 1 day after hospital discharge
measure: Inotropics use during and after the surgery
timeFrame: 1 day before surgery day, at the start of anesthetic induction, 2 hour, 4 hour after anesthetic induction, , postoperative ICU day 1, 2, 3
measure: The incidence of hypokalemia
timeFrame: 1 day before surgery day, at the start of anesthetic induction, 2 hour, 4 hour after anesthetic induction, , postoperative ICU day 1, 2, 3
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References: