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

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ClinicalTrials.gov Identifier: NCT01688648
Recruitment Status : Completed
First Posted : September 20, 2012
Last Update Posted : October 27, 2014
Sponsor:
Information provided by (Responsible Party):
Hyun Sung Cho, Samsung Medical Center

Tracking Information
First Submitted Date  ICMJE September 10, 2012
First Posted Date  ICMJE September 20, 2012
Last Update Posted Date October 27, 2014
Study Start Date  ICMJE September 2012
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 16, 2012)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 16, 2012)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison Between Lidocaine, Dexmedetomidine, and Their Combined Infusion in Subjects Undergoing Coronary Artery Bypass Graft
Official Title  ICMJE The Comparison of Antiarrhythmic and Myocardial Protective Effect Between Lidocaine, Dexmedetomidine, and Their Combined Infusion in Subjects Undergoing Coronary Artery Bypass Graft
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Condition  ICMJE
  • Unstable Angina
  • Coronary Artery Bypass Graft
  • Dexmedetomidine
  • Lidocaine
  • Myocardial Injury
  • Arrhythmia
  • Blood Electrolyte Balance
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Lidocaine infusion
  • 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
    Intervention: Drug: Dexmedetomidine infusion
  • Experimental: Combined infusion group
    Combined lidocaine and dexmedetomidine infusion with the dose specified in single infusion group
    Interventions:
    • Drug: Lidocaine infusion
    • Drug: Dexmedetomidine infusion
  • No Intervention: Control group
    The group without infusion of lidocaine or dexmedetomidine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 16, 2012)
160
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2013
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01688648
Other Study ID Numbers  ICMJE 2012-07-098-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hyun Sung Cho, Samsung Medical Center
Study Sponsor  ICMJE Samsung Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Samsung Medical Center
Verification Date October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP