<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01688648</url>
  </required_header>
  <id_info>
    <org_study_id>2012-07-098-001</org_study_id>
    <nct_id>NCT01688648</nct_id>
  </id_info>
  <brief_title>Comparison Between Lidocaine, Dexmedetomidine, and Their Combined Infusion in Subjects Undergoing Coronary Artery Bypass Graft</brief_title>
  <official_title>The Comparison of Antiarrhythmic and Myocardial Protective Effect Between Lidocaine, Dexmedetomidine, and Their Combined Infusion in Subjects Undergoing Coronary Artery Bypass Graft</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Samsung Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Samsung Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the present study is to compare the antiarrhythmic and myocardial protective&#xD;
      effect between lidocaine, dexmedetomidine, and their combined infusion in subjects undergoing&#xD;
      coronary artery bypass graft.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Lidocaine has been reported to have an antiarrhythmic and myocardial protective effect. A&#xD;
      previous study has reported that low-dose lidocaine infusion can decrease the incidence of&#xD;
      ventricular fibrillation and tachycardia during the first 24 hours after coronary artery&#xD;
      bypass graft (CABG). A recent study also reported that the lidocaine infusion during CABG&#xD;
      could decrease the myocardial injury by measuring the CK-MB and Troponin-I blood level.&#xD;
&#xD;
      Dexmedetomidine is an alpha-2 agonist and reduces the sympathetic tone and neuroendocrine&#xD;
      stress response. Dexmedetomidine was reported to have a cardioprotective effect by a previous&#xD;
      animal study. However, there was no clinical study evaluating the cardioprotective effect of&#xD;
      dexmedetomidine.&#xD;
&#xD;
      Therefore, we are trying to evaluate and compare the antiarrhythmic and myocardial protective&#xD;
      effect between lidocaine, dexmedetomidine, and their combined infusion in subjects undergoing&#xD;
      coronary artery bypass graft.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">February 2013</completion_date>
  <primary_completion_date type="Actual">February 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Myocardial injury marker</measure>
    <time_frame>postoperative ICU day 1</time_frame>
    <description>Myocardial injury marker - CK-MB, and Troponin(i) blood level</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Myocardial injury marker</measure>
    <time_frame>postoperative ICU day 2</time_frame>
    <description>Myocardial injury marker - CK-MB, and Troponin(i) blood level</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Myocardial injury marker</measure>
    <time_frame>postoperative ICU day 3</time_frame>
    <description>Myocardial injury marker - CK-MB, and Troponin(i) blood level</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The blood sodium, potassium, calcium level</measure>
    <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</time_frame>
    <description>The blood sodium, potassium, calcium level</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The incidence of arrhythmia during and after the surgery</measure>
    <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</time_frame>
    <description>The incidence of arrhythmia during and after the surgery:&#xD;
Ventricular premature beat,Atrial premature complex, Bigeminy, Trigeminy, Atrial fibrillation, Ventricular tachycardia, Ventricular fibrillation, Atrio-Ventricular block, PSVT, Junctional rhythm, External pacing</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative ICU stay, Hospital stay, Extubation time</measure>
    <time_frame>1 day after hospital discharge</time_frame>
    <description>Postoperative ICU stay, Hospital stay</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inotropics use during and after the surgery</measure>
    <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</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The incidence of hypokalemia</measure>
    <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</time_frame>
    <description>The incidence of hypokalemia</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">160</enrollment>
  <condition>Unstable Angina</condition>
  <condition>Coronary Artery Bypass Graft</condition>
  <condition>Dexmedetomidine</condition>
  <condition>Lidocaine</condition>
  <condition>Myocardial Injury</condition>
  <condition>Arrhythmia</condition>
  <condition>Blood Electrolyte Balance</condition>
  <arm_group>
    <arm_group_label>Lidocaine group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dexmedetomidine group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dexmedetomidine infusion during anesthetic induction with 0.2 mcg/kg/hr followed by 0.3 ~ 0.7 mcg/kg/hr during the surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Combined infusion group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Combined lidocaine and dexmedetomidine infusion with the dose specified in single infusion group</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The group without infusion of lidocaine or dexmedetomidine</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lidocaine infusion</intervention_name>
    <description>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.</description>
    <arm_group_label>Combined infusion group</arm_group_label>
    <arm_group_label>Lidocaine group</arm_group_label>
    <other_name>2% lidocaine hydrochloride</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexmedetomidine infusion</intervention_name>
    <description>Dexmedetomidine infusion during anesthetic induction with 0.2 mcg/kg/hr followed by 0.3 ~ 0.7 mcg/kg/hr during the surgery</description>
    <arm_group_label>Combined infusion group</arm_group_label>
    <arm_group_label>Dexmedetomidine group</arm_group_label>
    <other_name>Precedex injection</other_name>
    <other_name>Dexmedetomidine hydrochloride 118 mcg/ml</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Those undergoing off-pump coronary artery bypass graft during the study period in&#xD;
             Samsung Medical Center&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any patients with plasma aldosterone, or glucocorticoid disorder including primary&#xD;
             hyperaldosteronism, renovascular hypertension, rennin-secreting tumor, salt-wasting&#xD;
             renal disease, Cushing syndrome&#xD;
&#xD;
          -  Patients with recent exogenous steroid administration or previous diuretics therapy&#xD;
&#xD;
          -  Patients with recent myocardial infarction&#xD;
&#xD;
          -  Those undergoing unplanned cardiopulmonary bypass during the surgery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Samsung Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>135-710</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>October 2014</verification_date>
  <study_first_submitted>September 10, 2012</study_first_submitted>
  <study_first_submitted_qc>September 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 20, 2012</study_first_posted>
  <last_update_submitted>October 24, 2014</last_update_submitted>
  <last_update_submitted_qc>October 24, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 27, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Samsung Medical Center</investigator_affiliation>
    <investigator_full_name>Hyun Sung Cho</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Coronary artery bypass graft</keyword>
  <keyword>dexmedetomidine</keyword>
  <keyword>lidocaine</keyword>
  <keyword>myocardial injury</keyword>
  <keyword>arrhythmia</keyword>
  <keyword>blood electrolyte balance</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arrhythmias, Cardiac</mesh_term>
    <mesh_term>Angina, Unstable</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lidocaine</mesh_term>
    <mesh_term>Dexmedetomidine</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01688648
org study id: 2012-07-098-001
nct id: NCT01688648
lead sponsor: 
has dmc: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
masking: Double (Participant, Outcomes Assessor)
measure: Myocardial injury marker
time frame: postoperative ICU day 1
description: Myocardial injury marker - CK-MB, and Troponin(i) blood level
measure: Myocardial injury marker
time frame: postoperative ICU day 2
description: Myocardial injury marker - CK-MB, and Troponin(i) blood level
measure: Myocardial injury marker
time frame: postoperative ICU day 3
description: Myocardial injury marker - CK-MB, and Troponin(i) blood level
measure: 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
description: The blood sodium, potassium, calcium level
measure: 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
description: 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
measure: Postoperative ICU stay, Hospital stay, Extubation time
time frame: 1 day after hospital discharge
description: Postoperative ICU stay, Hospital stay
measure: 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
description: 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
measure: 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
description: The incidence of hypokalemia
arm group label: Lidocaine group
arm group type: Experimental
description: 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.
arm group label: Dexmedetomidine group
arm group type: Experimental
description: Dexmedetomidine infusion during anesthetic induction with 0.2 mcg/kg/hr followed by 0.3 ~ 0.7 mcg/kg/hr during the surgery
arm group label: Combined infusion group
arm group type: Experimental
description: Combined lidocaine and dexmedetomidine infusion with the dose specified in single infusion group
arm group label: Control group
arm group type: No Intervention
description: The group without infusion of lidocaine or dexmedetomidine
intervention type: Drug
intervention name: Lidocaine infusion
description: 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.
arm group label: Combined infusion group
arm group label: Lidocaine group
other name: 2% lidocaine hydrochloride
intervention type: Drug
intervention name: Dexmedetomidine infusion
description: Dexmedetomidine infusion during anesthetic induction with 0.2 mcg/kg/hr followed by 0.3 ~ 0.7 mcg/kg/hr during the surgery
arm group label: Combined infusion group
arm group label: Dexmedetomidine group
other name: Precedex injection
other name: Dexmedetomidine hydrochloride 118 mcg/ml
criteria: 
gender: All
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Samsung Medical Center
investigator full name: Hyun Sung Cho
investigator title: Professor
mesh term: Arrhythmias, Cardiac
mesh term: Angina, Unstable
mesh term: Lidocaine
mesh term: Dexmedetomidine