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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by Samsung Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Hyun Sung Cho, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01688648
First received: September 10, 2012
Last updated: September 16, 2012
Last verified: September 2012
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 Samsung Medical Center:

Primary Outcome Measures:
  • Myocardial injury marker [ Time Frame: postoperative ICU day 1 ] [ Designated as safety issue: No ]
    Myocardial injury marker - CK-MB, and Troponin(i) blood level

  • Myocardial injury marker [ Time Frame: postoperative ICU day 2 ] [ Designated as safety issue: No ]
    Myocardial injury marker - CK-MB, and Troponin(i) blood level

  • Myocardial injury marker [ Time Frame: postoperative ICU day 3 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]

    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    The incidence of hypokalemia


Estimated Enrollment: 160
Study Start Date: September 2012
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 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

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01688648

Contacts
Contact: Hyun Sung Cho, MD, PhD +82-2-3410-0264 chohs.cho@samsung.com
Contact: Won Ho Kim, MD +82-2-3410-2470 bullet57@naver.com

Locations
Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 135-710
Contact: Won Ho Kim, MD    +82-2-3410-2470    bullet57@naver.com   
Sponsors and Collaborators
Samsung Medical Center
  More Information

No publications provided

Responsible Party: Hyun Sung Cho, Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01688648     History of Changes
Other Study ID Numbers: 2012-07-098-001
Study First Received: September 10, 2012
Last Updated: September 16, 2012
Health Authority: South Korea: Institutional Review Board

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

Additional relevant MeSH terms:
Angina, Unstable
Angina Pectoris
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Anesthetics
Lidocaine
Dexmedetomidine
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Cardiovascular 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

ClinicalTrials.gov processed this record on September 18, 2014