<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/NCT02222142</url>
  </required_header>
  <id_info>
    <org_study_id>2013-09-127</org_study_id>
    <nct_id>NCT02222142</nct_id>
  </id_info>
  <brief_title>Volatile Versus Propofol Anesthesia in OPCAB</brief_title>
  <official_title>Comparison of Propofol and Isoflurane Anesthesia on Cardioprotection and Clinical Outcomes in Patients Undergoing Off-pump Coronary Artery Bypass Graft Surgery : A Propensity-score Analysis</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>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Off pump coronary artery bypass graft (OPCAB) still requires myocardial protection owing to&#xD;
      intermittent regional ischemic episode. The investigators retrospectively evaluated the&#xD;
      cardioprotective and clinical outcomes of propofol versus isoflurane anesthesia in patients&#xD;
      undergoing OPCAB.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Several experimental and clinical researches have suggested that volatile anesthetics may&#xD;
      reduce mortality in cardiac surgery owing to its preconditioning induced cardioprotective&#xD;
      effect. Off-pump coronary artery bypass graft (OPCAB) surgery still requires cardioprotective&#xD;
      strategies due to coronary hypoperfusion during anastomosis. The aim of this study was to&#xD;
      evaluate the possible cardioprotective effect and clinical outcomes of propofol versus&#xD;
      isoflurane anesthesia in patients undergoing OPCAB using propensity matching.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2010</start_date>
  <completion_date type="Actual">December 2012</completion_date>
  <primary_completion_date type="Actual">December 2012</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>CK-MB, CRP</measure>
    <time_frame>Change from preoperative value in CK-MR and CRP at Postoperative day(POD), POD 1 and 2</time_frame>
    <description>Comparison of CK-MB and CRP values between propofol and isoflurane groups on postoperative day, POD1 and POD 2</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical adverse outcomes</measure>
    <time_frame>until 1 year after OPCAB</time_frame>
    <description>clinical adverse outcomes until postoperative 1 year</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Cardioprotection and clinical adverse outcomes in diabetic patients</measure>
    <time_frame>POD, POD 1, POD 2, one month, one year</time_frame>
    <description>primary and secondary outcome analysis in diabetic patients</description>
  </other_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">1080</enrollment>
  <condition>Off Pump Coronary Artery Bypass Graft</condition>
  <arm_group>
    <arm_group_label>Isoflurane group</arm_group_label>
    <description>Isoflurane inhalational anesthesia during OPCAB</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Propofol group</arm_group_label>
    <description>Total intravenous anesthesia with propofol during OPCAB</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Isoflurane</intervention_name>
    <description>Comparison between isoflurane and propofol, Retrospective study</description>
    <arm_group_label>Isoflurane group</arm_group_label>
    <other_name>inhalational anesthetics</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        patients underwent OPCAB from January, 2010 to December, 2012&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  OPCAB&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  On pump conversion&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</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>August 2014</verification_date>
  <study_first_submitted>August 17, 2014</study_first_submitted>
  <study_first_submitted_qc>August 20, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 21, 2014</study_first_posted>
  <last_update_submitted>August 20, 2014</last_update_submitted>
  <last_update_submitted_qc>August 20, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 21, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Samsung Medical Center</investigator_affiliation>
    <investigator_full_name>Jong Hwan Lee</investigator_full_name>
    <investigator_title>Assistant professor</investigator_title>
  </responsible_party>
  <keyword>Ischemic heart disease</keyword>
  <keyword>Off pump coronary artery bypass graft</keyword>
  <keyword>Isoflurane</keyword>
  <keyword>Propofol</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anesthetics</mesh_term>
    <mesh_term>Isoflurane</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/NCT02222142
org study id: 2013-09-127
nct id: NCT02222142
lead sponsor: 
has dmc: Yes
Off pump coronary artery bypass graft (OPCAB) still requires myocardial protection owing to
      intermittent regional ischemic episode. The investigators retrospectively evaluated the
      cardioprotective and clinical outcomes of propofol versus isoflurane anesthesia in patients
      undergoing OPCAB.
Several experimental and clinical researches have suggested that volatile anesthetics may
      reduce mortality in cardiac surgery owing to its preconditioning induced cardioprotective
      effect. Off-pump coronary artery bypass graft (OPCAB) surgery still requires cardioprotective
      strategies due to coronary hypoperfusion during anastomosis. The aim of this study was to
      evaluate the possible cardioprotective effect and clinical outcomes of propofol versus
      isoflurane anesthesia in patients undergoing OPCAB using propensity matching.
observational model: Case-Control
time perspective: Retrospective
measure: CK-MB, CRP
time frame: Change from preoperative value in CK-MR and CRP at Postoperative day(POD), POD 1 and 2
description: Comparison of CK-MB and CRP values between propofol and isoflurane groups on postoperative day, POD1 and POD 2
measure: Clinical adverse outcomes
time frame: until 1 year after OPCAB
description: clinical adverse outcomes until postoperative 1 year
measure: Cardioprotection and clinical adverse outcomes in diabetic patients
time frame: POD, POD 1, POD 2, one month, one year
description: primary and secondary outcome analysis in diabetic patients
arm group label: Isoflurane group
description: Isoflurane inhalational anesthesia during OPCAB
arm group label: Propofol group
description: Total intravenous anesthesia with propofol during OPCAB
intervention type: Drug
intervention name: Isoflurane
description: Comparison between isoflurane and propofol, Retrospective study
arm group label: Isoflurane group
other name: inhalational anesthetics
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Samsung Medical Center
investigator full name: Jong Hwan Lee
investigator title: Assistant professor
mesh term: Anesthetics
mesh term: Isoflurane