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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01688648
First Posted: September 20, 2012
Last Update Posted: October 27, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hyun Sung Cho, Samsung Medical Center
  Purpose
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 Intervention
Unstable Angina Coronary Artery Bypass Graft Dexmedetomidine Lidocaine Myocardial Injury Arrhythmia Blood Electrolyte Balance Drug: Lidocaine infusion Drug: Dexmedetomidine infusion

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Hyun Sung Cho, Samsung Medical Center:

Primary Outcome Measures:
  • Myocardial injury marker [ Time Frame: postoperative ICU day 1 ]
    Myocardial injury marker - CK-MB, and Troponin(i) blood level

  • Myocardial injury marker [ Time Frame: postoperative ICU day 2 ]
    Myocardial injury marker - CK-MB, and Troponin(i) blood level

  • Myocardial injury marker [ Time Frame: postoperative ICU day 3 ]
    Myocardial injury marker - CK-MB, and Troponin(i) blood level


Secondary Outcome Measures:
  • 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

  • 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


  • Postoperative ICU stay, Hospital stay, Extubation time [ Time Frame: 1 day after hospital discharge ]
    Postoperative ICU stay, Hospital stay

  • 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

  • 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


Enrollment: 160
Study Start Date: September 2012
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01688648


Locations
Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
Samsung Medical Center
  More Information

Responsible Party: Hyun Sung Cho, Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01688648     History of Changes
Other Study ID Numbers: 2012-07-098-001
First Submitted: September 10, 2012
First Posted: September 20, 2012
Last Update Posted: October 27, 2014
Last Verified: October 2014

Keywords provided by Hyun Sung Cho, Samsung Medical Center:
Coronary artery bypass graft
dexmedetomidine
lidocaine
myocardial injury
arrhythmia
blood electrolyte balance

Additional relevant MeSH terms:
Angina, Unstable
Angina Pectoris
Chest Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Signs and Symptoms
Lidocaine
Anesthetics
Dexmedetomidine
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Hypnotics and Sedatives
Analgesics, Non-Narcotic
Analgesics
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists