<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/NCT02217319</url>
  </required_header>
  <id_info>
    <org_study_id>HSK005</org_study_id>
    <nct_id>NCT02217319</nct_id>
  </id_info>
  <brief_title>Cardioprotection by Sevoflurane Preconditioning in Noncardiac Thoracic Surgery</brief_title>
  <official_title>Does a Sevoflurane Preconditioning Have Cardioprotective Properties in Noncardiac Thoracic Surgery?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dr. Horst Schmidt Klinik GmbH</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Dr. Horst Schmidt Klinik GmbH</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      It has been shown that the use of volatile anaesthetics, that are usually used to perform a&#xD;
      general anesthesia, have cardioprotective properties. This has been shown in animal studies&#xD;
      and in patients that underwent cardiac surgery. The aim of our study is to examine if&#xD;
      Sevoflurane, a volatile anaesthetic, has this properties in patients undergoing lung surgery.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">September 2013</completion_date>
  <primary_completion_date type="Actual">August 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>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Troponin T</measure>
    <time_frame>change of Troponin T levels preoperative and postoperative up to 40 hours after surgery</time_frame>
    <description>assessing a change in high sensitive Troponin T (5th generation) Level before and at six time points after surgery (right after surgery, every 8 hours up to 40 hours after surgery)</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>High Sensitive Troponin T Release</condition>
  <arm_group>
    <arm_group_label>Sevoflurane</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients receive Sevoflurane 1 MAC (minimal alveolar concentration) after induction of anesthesia with propofol, remifentanil and atracurium for 30 minutes as preconditioning.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TIVA</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Patients received the standard total intravenous anesthesia (TIVA) with propofol, remifentanil and atracurium.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sevoflurane</intervention_name>
    <description>Anaesthesia is induced (1-2 mg/kg) and maintained (5-7 mg/kg/h) with propofol and remifentanil (1 µg/kg and 0,2-0,4 µg/kg/min). After induction of anesthesia the propofol infusion is stopped and patients receive 1 MAC Sevoflurane over 30 min. Then the propofol infusion is restarted and Sevoflurane is washed out.</description>
    <arm_group_label>Sevoflurane</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>TIVA</intervention_name>
    <description>Anaesthesia is induced (1-2 mg/kg) and maintained (5-7 mg/kg/h) with propofol and remifentanil (1 µg/kg and 0,2-0,4 µg/kg/min).</description>
    <arm_group_label>TIVA</arm_group_label>
    <other_name>Placebo</other_name>
    <other_name>Controll</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Lung surgery&#xD;
&#xD;
          -  ASA (American Society of Anesthesiologists) physical status 1-3&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Disposition for malignant hyperthermia&#xD;
&#xD;
          -  Medication with ß-blocking drugs&#xD;
&#xD;
          -  Use of clonidin&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Dr Horst Schmidt Klinik</name>
      <address>
        <city>Wiesbaden</city>
        <zip>65199</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>August 2016</verification_date>
  <study_first_submitted>August 8, 2014</study_first_submitted>
  <study_first_submitted_qc>August 13, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2014</study_first_posted>
  <last_update_submitted>August 1, 2016</last_update_submitted>
  <last_update_submitted_qc>August 1, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 3, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Volatile Anesthetic</keyword>
  <keyword>Cardioprotection</keyword>
  <keyword>Lung surgery</keyword>
  <keyword>non cardiac surgery</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypersensitivity</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sevoflurane</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/NCT02217319
org study id: HSK005
nct id: NCT02217319
lead sponsor: 
has dmc: No
It has been shown that the use of volatile anaesthetics, that are usually used to perform a
      general anesthesia, have cardioprotective properties. This has been shown in animal studies
      and in patients that underwent cardiac surgery. The aim of our study is to examine if
      Sevoflurane, a volatile anaesthetic, has this properties in patients undergoing lung surgery.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Participant)
measure: Troponin T
time frame: change of Troponin T levels preoperative and postoperative up to 40 hours after surgery
description: assessing a change in high sensitive Troponin T (5th generation) Level before and at six time points after surgery (right after surgery, every 8 hours up to 40 hours after surgery)
arm group label: Sevoflurane
arm group type: Active Comparator
description: Patients receive Sevoflurane 1 MAC (minimal alveolar concentration) after induction of anesthesia with propofol, remifentanil and atracurium for 30 minutes as preconditioning.
arm group label: TIVA
arm group type: Placebo Comparator
description: Patients received the standard total intravenous anesthesia (TIVA) with propofol, remifentanil and atracurium.
intervention type: Drug
intervention name: Sevoflurane
description: Anaesthesia is induced (1-2 mg/kg) and maintained (5-7 mg/kg/h) with propofol and remifentanil (1 µg/kg and 0,2-0,4 µg/kg/min). After induction of anesthesia the propofol infusion is stopped and patients receive 1 MAC Sevoflurane over 30 min. Then the propofol infusion is restarted and Sevoflurane is washed out.
arm group label: Sevoflurane
intervention type: Drug
intervention name: TIVA
description: Anaesthesia is induced (1-2 mg/kg) and maintained (5-7 mg/kg/h) with propofol and remifentanil (1 µg/kg and 0,2-0,4 µg/kg/min).
arm group label: TIVA
other name: Placebo
other name: Controll
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Hypersensitivity
mesh term: Sevoflurane