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NCT Number: NCT01688648

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

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.

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Key information

Conditions

Unstable Angina Angina Pectoris Angina, Unstable Arrhythmia Arrhythmias, Cardiac Blood Electrolyte Balance Cardiovascular Diseases Chest Pain Coronary Artery Bypass Graft Dexmedetomidine Heart Diseases Lidocaine Myocardial Injury Myocardial Ischemia Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Samsung Medical Center

Seoul, 135-710, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lidocaine infusion

Drug

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

Dexmedetomidine infusion

Drug

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

Primary outcomes

  1. Myocardial injury marker

    Time frame: postoperative ICU day 1

    Myocardial injury marker - CK-MB, and Troponin(i) blood level

  2. Myocardial injury marker

    Time frame: postoperative ICU day 2

    Myocardial injury marker - CK-MB, and Troponin(i) blood level

  3. Myocardial injury marker

    Time frame: postoperative ICU day 3

    Myocardial injury marker - CK-MB, and Troponin(i) blood level

Secondary outcomes

  1. The blood sodium, potassium, calcium level

    Time frame: 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

  2. The incidence of arrhythmia during and after the surgery

    Time frame: 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

  3. Postoperative ICU stay, Hospital stay, Extubation time

    Time frame: 1 day after hospital discharge

    Postoperative ICU stay, Hospital stay

  4. Inotropics use during and after the surgery

    Time frame: 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

  5. The incidence of hypokalemia

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Sep 20, 2012
Registry last updated
Oct 27, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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