<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/NCT03015350</url>
  </required_header>
  <id_info>
    <org_study_id>One lung ventilation</org_study_id>
    <nct_id>NCT03015350</nct_id>
  </id_info>
  <brief_title>Blood Levels of Sevoflurane and Desflurane</brief_title>
  <official_title>Blood Levels of Sevoflurane and Desflurane During One Lung Ventilation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cukurova University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cukurova University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      16 patients with American Society of AnesthesioIogy (ASA) physical status I-III will&#xD;
      recruited to this study. Patients will divided to the 2 groups. %1.5 Sevoflurane will apply&#xD;
      in Group S and %6 Desflurane will apply in Group D. Each groups will divide 2 subgroups. Two&#xD;
      lung ventilation will be performed to Group Sa and Group Da, one lung ventilation will be&#xD;
      performed to Group Sb and Group Db. At the time point 40.minutes first blood sample will&#xD;
      given from patients. Blood sample will be taken at intervals of 10 minutes from groups of two&#xD;
      lung ventilation. In groups of one lung ventilation, blood samples will be taken at the time&#xD;
      interval of 10 minutes after one lung ventilation started. All blood samples will be assess&#xD;
      in Gas Chromatography.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Investigator aimed to assess blood level of sevoflurane and desflurane during two lung&#xD;
      ventilation and one lung ventilation. The investigators will use Gas Chromatography for&#xD;
      define drugs levels. 16 patients with ASA I-III patients who undergo thoracotomy and&#xD;
      abdominal surgery will be recruited to this study. Patients will divided in to the 2 groups.&#xD;
      %1.5 Sevoflurane will apply in Group S and %6 Desflurane will apply in Group D during&#xD;
      anesthesia maintenance. Each groups will divide 2 subgroups which are one lung ventilation&#xD;
      groups and two lung ventilation groups. Two lung ventilation will be performed to Group Sa&#xD;
      and Group Da, one lung ventilation will be performed to Group Sb and Group Db. Sequential&#xD;
      blood samples will be taken from both arterial and central venous canula at the same time&#xD;
      point. First blood samples will be taken at 40. minutes of anesthesia. Sequential samples&#xD;
      will be taken at interval of 10 minutes during two lung ventilation. In one lung ventilation&#xD;
      second blood samples will be taken at the 10. minutes of one lung ventilation. After than at&#xD;
      the interval of 10 minutes, collection of blood samples both arterial and central venous will&#xD;
      be continue.&#xD;
&#xD;
      All collection will assess with gas chromatography.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2016</start_date>
  <completion_date type="Actual">December 2017</completion_date>
  <primary_completion_date type="Actual">December 2017</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Measurement of blood levels of Sevoflurane and Desflurane</measure>
    <time_frame>from 40th minute to the end of the operation</time_frame>
    <description>Data collections will be ensured from arterial and venous blood sample and than samples will be assessed with gas chromatography and blood sevoflurane and desflurane level will be measured. Blood samples will take every 10 minutes. Only blood levels of sevoflurane and desflurane will be assessed.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>determine of ventilation-perfusion mismatch with p(A-a)O2</measure>
    <time_frame>from 40th minute to the end of the one lung ventilation</time_frame>
    <description>During one lung ventilation, p(a-A)O2 will be assessed with arterial blood analyses</description>
  </secondary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Actual">16</enrollment>
  <condition>Anesthetics, Inhalation</condition>
  <arm_group>
    <arm_group_label>two lung ventilation of Sevoflurane</arm_group_label>
    <description>In GroupSa, 1,5 % sevoflurane will be apply continuously and blood samples will be taken at intervals of 10 minutes starting from the 40th minute.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>one lung ventilation of Sevoflurane</arm_group_label>
    <description>In GroupSa, 1,5 % sevoflurane will be apply continuously and first samples will taken at the 40. minutes and collection of blood samples will be continue at intervals of 10 minutes after one lung ventilation started.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>two lung ventilation of Desflurane</arm_group_label>
    <description>In GroupSa, 6 % desflurane will be apply continuously and blood samples will be taken at intervals of 10 minutes starting from the 40th minute.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>one lung ventilation of desflurane</arm_group_label>
    <description>In GroupSa, 6 % desflurane will be apply continuously and first samples will taken at the 40. minutes and collection of blood samples will be continue at intervals of 10 minutes after one lung ventilation started.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sevoflurane</intervention_name>
    <description>Measurement of blood desflurane level during one lung ventilation</description>
    <arm_group_label>one lung ventilation of Sevoflurane</arm_group_label>
    <arm_group_label>two lung ventilation of Sevoflurane</arm_group_label>
    <other_name>Blood sevoflurane level</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Desflurane</intervention_name>
    <description>Measurement of blood desflurane level during one lung ventilation</description>
    <arm_group_label>one lung ventilation of desflurane</arm_group_label>
    <arm_group_label>two lung ventilation of Desflurane</arm_group_label>
    <other_name>Blood desflurane level</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        16 patients with ASA I-III who undergo thoracotomy or abdominal surgery&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria: ASA I-II patients&#xD;
&#xD;
          -  Who undergo thoracotomy or abdominal surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  ASA IV and up patients&#xD;
&#xD;
          -  Patients who taken inotropic agent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ebru Biricik, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cukurova University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ebru Biricik</name>
      <address>
        <city>Adana</city>
        <state>In The USA Or Canada, Please Select...</state>
        <zip>01380</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>November 2017</verification_date>
  <study_first_submitted>December 27, 2016</study_first_submitted>
  <study_first_submitted_qc>January 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 10, 2017</study_first_posted>
  <last_update_submitted>March 2, 2018</last_update_submitted>
  <last_update_submitted_qc>March 2, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 5, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cukurova University</investigator_affiliation>
    <investigator_full_name>ebru biricik</investigator_full_name>
    <investigator_title>MD, Anesthesiology specialist</investigator_title>
  </responsible_party>
  <keyword>blood sevoflurane concentration</keyword>
  <keyword>blood desflurane concentration</keyword>
  <keyword>one lung ventilation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Aspiration</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sevoflurane</mesh_term>
    <mesh_term>Desflurane</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03015350
org study id: One lung ventilation
nct id: NCT03015350
lead sponsor: 
has dmc: No
16 patients with American Society of AnesthesioIogy (ASA) physical status I-III will
      recruited to this study. Patients will divided to the 2 groups. %1.5 Sevoflurane will apply
      in Group S and %6 Desflurane will apply in Group D. Each groups will divide 2 subgroups. Two
      lung ventilation will be performed to Group Sa and Group Da, one lung ventilation will be
      performed to Group Sb and Group Db. At the time point 40.minutes first blood sample will
      given from patients. Blood sample will be taken at intervals of 10 minutes from groups of two
      lung ventilation. In groups of one lung ventilation, blood samples will be taken at the time
      interval of 10 minutes after one lung ventilation started. All blood samples will be assess
      in Gas Chromatography.
Investigator aimed to assess blood level of sevoflurane and desflurane during two lung
      ventilation and one lung ventilation. The investigators will use Gas Chromatography for
      define drugs levels. 16 patients with ASA I-III patients who undergo thoracotomy and
      abdominal surgery will be recruited to this study. Patients will divided in to the 2 groups.
      %1.5 Sevoflurane will apply in Group S and %6 Desflurane will apply in Group D during
      anesthesia maintenance. Each groups will divide 2 subgroups which are one lung ventilation
      groups and two lung ventilation groups. Two lung ventilation will be performed to Group Sa
      and Group Da, one lung ventilation will be performed to Group Sb and Group Db. Sequential
      blood samples will be taken from both arterial and central venous canula at the same time
      point. First blood samples will be taken at 40. minutes of anesthesia. Sequential samples
      will be taken at interval of 10 minutes during two lung ventilation. In one lung ventilation
      second blood samples will be taken at the 10. minutes of one lung ventilation. After than at
      the interval of 10 minutes, collection of blood samples both arterial and central venous will
      be continue.

      All collection will assess with gas chromatography.
observational model: Case-Control
time perspective: Prospective
measure: Measurement of blood levels of Sevoflurane and Desflurane
time frame: from 40th minute to the end of the operation
description: Data collections will be ensured from arterial and venous blood sample and than samples will be assessed with gas chromatography and blood sevoflurane and desflurane level will be measured. Blood samples will take every 10 minutes. Only blood levels of sevoflurane and desflurane will be assessed.
measure: determine of ventilation-perfusion mismatch with p(A-a)O2
time frame: from 40th minute to the end of the one lung ventilation
description: During one lung ventilation, p(a-A)O2 will be assessed with arterial blood analyses
arm group label: two lung ventilation of Sevoflurane
description: In GroupSa, 1,5 % sevoflurane will be apply continuously and blood samples will be taken at intervals of 10 minutes starting from the 40th minute.
arm group label: one lung ventilation of Sevoflurane
description: In GroupSa, 1,5 % sevoflurane will be apply continuously and first samples will taken at the 40. minutes and collection of blood samples will be continue at intervals of 10 minutes after one lung ventilation started.
arm group label: two lung ventilation of Desflurane
description: In GroupSa, 6 % desflurane will be apply continuously and blood samples will be taken at intervals of 10 minutes starting from the 40th minute.
arm group label: one lung ventilation of desflurane
description: In GroupSa, 6 % desflurane will be apply continuously and first samples will taken at the 40. minutes and collection of blood samples will be continue at intervals of 10 minutes after one lung ventilation started.
intervention type: Drug
intervention name: Sevoflurane
description: Measurement of blood desflurane level during one lung ventilation
arm group label: one lung ventilation of Sevoflurane
arm group label: two lung ventilation of Sevoflurane
other name: Blood sevoflurane level
intervention type: Drug
intervention name: Desflurane
description: Measurement of blood desflurane level during one lung ventilation
arm group label: one lung ventilation of desflurane
arm group label: two lung ventilation of Desflurane
other name: Blood desflurane level
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 25 Years
maximum age: 65 Years
healthy volunteers: No
last name: Ebru Biricik, MD
role: Principal Investigator
affiliation: Cukurova University
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Cukurova University
investigator full name: ebru biricik
investigator title: MD, Anesthesiology specialist
mesh term: Respiratory Aspiration
mesh term: Sevoflurane
mesh term: Desflurane
sharing ipd: No