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

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Comparison of Antiarrhythmic and Myocardial Protective Effect Between Lidocaine, Dexmedetomidine, and Their Combined Infusion in Subjects Undergoing Coronary Artery Bypass Graft

Conditions
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Unstable Angina, Coronary Artery Bypass Graft, Dexmedetomidine, Lidocaine, Myocardial Injury, Arrhythmia, Blood Electrolyte Balance

Intervention / Treatment
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* Drug: Lidocaine infusion
* Drug: Dexmedetomidine infusion


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lidocaine group<br>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<br>* 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.<br>* Other names: 2% lidocaine hydrochloride;|
| Experimental: Dexmedetomidine group<br>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<br>* Dexmedetomidine infusion during anesthetic induction with 0.2 mcg/kg/hr followed by 0.3   0.7 mcg/kg/hr during the surgery<br>* Other names: Dexmedetomidine hydrochloride 118 mcg/ml;|
| Experimental: Combined infusion group<br>Combined lidocaine and dexmedetomidine infusion with the dose specified in single infusion group | Drug: Lidocaine infusion<br>* 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.<br>* Other names: 2% lidocaine hydrochloride;Drug: Dexmedetomidine infusion<br>* Dexmedetomidine infusion during anesthetic induction with 0.2 mcg/kg/hr followed by 0.3   0.7 mcg/kg/hr during the surgery<br>* Other names: Dexmedetomidine hydrochloride 118 mcg/ml;|
| No Intervention: Control group<br>The group without infusion of lidocaine or dexmedetomidine | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Myocardial injury marker | Myocardial injury marker - CK-MB, and Troponin(i) blood level | postoperative ICU day 1 | 
| Myocardial injury marker | Myocardial injury marker - CK-MB, and Troponin(i) blood level | postoperative ICU day 2 | 
| Myocardial injury marker | Myocardial injury marker - CK-MB, and Troponin(i) blood level | postoperative ICU day 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The blood sodium, potassium, calcium level | 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 incidence of arrhythmia during and after the surgery | 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 | 1 day before surgery day, at the start of anesthetic induction, 2 hour, 4 hour after anesthetic induction, postoperative ICU day 1, 2, 3 | 
| Postoperative ICU stay, Hospital stay, Extubation time | Postoperative ICU stay, Hospital stay | 1 day after hospital discharge | 
| Inotropics use during and after the surgery | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary artery bypass graft, dexmedetomidine, lidocaine, myocardial injury, arrhythmia, blood electrolyte balance