Comparison Between Lidocaine, Dexmedetomidine, and Their Combined Infusion in Subjects Undergoing Coronary Artery Bypass Graft

Sponsor

Samsung Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT01688648

Collaborator

(none)

160

Enrollment

Location

Arms

Duration (Months)

31.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Unstable Angina Coronary Artery Bypass Graft Dexmedetomidine Lidocaine Myocardial Injury Arrhythmia Blood Electrolyte Balance	Drug: Lidocaine infusion Drug: Dexmedetomidine infusion	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

160 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

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 Start Date :

Sep 1, 2012

Actual Primary Completion Date :

Feb 1, 2013

Actual Study Completion Date :

Feb 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Lidocaine group a bolus dose of lidocaine 1.5 mg/kg after anesthetic induction with following lidocaine infusion with 2 mg/kg/hr during the surgery and same dose during postoperative 24 hour in ICU.	Drug: Lidocaine infusion a bolus dose of Lidocaine 1.5 mg/kg after anesthetic induction with following infusion with 2 mg/kg/hr during the surgery and same dose during postoperative 24 hour in ICU. Other Names: 2% lidocaine hydrochloride
Experimental: Dexmedetomidine group Dexmedetomidine infusion during anesthetic induction with 0.2 mcg/kg/hr followed by 0.3 ~ 0.7 mcg/kg/hr during the surgery	Drug: Dexmedetomidine infusion Dexmedetomidine infusion during anesthetic induction with 0.2 mcg/kg/hr followed by 0.3 ~ 0.7 mcg/kg/hr during the surgery Other Names: Precedex injection Dexmedetomidine hydrochloride 118 mcg/ml
Experimental: Combined infusion group Combined lidocaine and dexmedetomidine infusion with the dose specified in single infusion group	Drug: Lidocaine infusion a bolus dose of Lidocaine 1.5 mg/kg after anesthetic induction with following infusion with 2 mg/kg/hr during the surgery and same dose during postoperative 24 hour in ICU. Other Names: 2% lidocaine hydrochloride Drug: Dexmedetomidine infusion Dexmedetomidine infusion during anesthetic induction with 0.2 mcg/kg/hr followed by 0.3 ~ 0.7 mcg/kg/hr during the surgery Other Names: Precedex injection Dexmedetomidine hydrochloride 118 mcg/ml
No Intervention: Control group The group without infusion of lidocaine or dexmedetomidine

Outcome Measures

Primary Outcome Measures

Myocardial injury marker [postoperative ICU day 1]
Myocardial injury marker - CK-MB, and Troponin(i) blood level
Myocardial injury marker [postoperative ICU day 2]
Myocardial injury marker - CK-MB, and Troponin(i) blood level
Myocardial injury marker [postoperative ICU day 3]
Myocardial injury marker - CK-MB, and Troponin(i) blood level

Secondary Outcome Measures

The blood sodium, potassium, calcium level [1 day before surgery day, at the start of anesthetic induction, 2 hour, 4 hour after anesthetic induction, postoperative ICU day 1, 2, 3]
The blood sodium, potassium, calcium level
The incidence of arrhythmia during and after the surgery [1 day before surgery day, at the start of anesthetic induction, 2 hour, 4 hour after anesthetic induction, postoperative ICU day 1, 2, 3]
The incidence of arrhythmia during and after the surgery: Ventricular premature beat,Atrial premature complex, Bigeminy, Trigeminy, Atrial fibrillation, Ventricular tachycardia, Ventricular fibrillation, Atrio-Ventricular block, PSVT, Junctional rhythm, External pacing
Postoperative ICU stay, Hospital stay, Extubation time [1 day after hospital discharge]
Postoperative ICU stay, Hospital stay
Inotropics use during and after the surgery [1 day before surgery day, at the start of anesthetic induction, 2 hour, 4 hour after anesthetic induction, , postoperative ICU day 1, 2, 3]
Inotropics and other drug use during and after the surgery: Dopamine, NTG, dobutamine, milrinone, epinephrine, norepinephrine, amiodarone, diltiazem, remifentanil, esmolol, labetalol, nicardipine, Lasix, phenylephrine, lidocaine, sufentanil
The incidence of hypokalemia [1 day before surgery day, at the start of anesthetic induction, 2 hour, 4 hour after anesthetic induction, , postoperative ICU day 1, 2, 3]
The incidence of hypokalemia

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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