<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/NCT02191371</url>
  </required_header>
  <id_info>
    <org_study_id>PaO2 &amp; StO2 in OLV</org_study_id>
    <nct_id>NCT02191371</nct_id>
  </id_info>
  <brief_title>Effect of Anesthetics on Oxygenation and Microcirculation During One-lung Ventilation</brief_title>
  <official_title>Effect of Anesthetics on Oxygenation and Microcirculation During One-lung Ventilation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seoul National University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      One-lung ventilation during thoracic surgery may affect systemic oxygenation and peripheral&#xD;
      microcirculation by hypoxic pulmonary vasoconstriction. Both intravenous and inhalational&#xD;
      anesthetics can be used during one-lung ventilation. However, there is still a controversy&#xD;
      which anesthetic would be more appropriate during one-lung ventilation in the perspective of&#xD;
      oxygenation and microcirculation. The investigators hypothesized that intravenous and&#xD;
      inhalational anesthetics may affect oxygenation and microcirculation differently during&#xD;
      one-lung ventilation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients undergoing thoracic surgery including one-lung ventilation will be randomized to&#xD;
      receive intravenous (propofol) or inhalational (desflurane) anesthetic.&#xD;
&#xD;
      Systemic oxygenation can be evaluated by measuring partial pressure of oxygen in arterial&#xD;
      blood analysis. Microcirculatory parameters can be obtained from vascular occlusion test.&#xD;
      Among those parameters, recovery slope during vascular occlusion test is known to reflect&#xD;
      recruitment of microvasculature in response to hypoxic or ischemic insult. In this study, we&#xD;
      will compare arterial partial pressure of oxygen and recovery slope during one-lung&#xD;
      ventilation between propofol and desflurane group.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">December 2014</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>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>arterial partial pressure of oxygen</measure>
    <time_frame>30 min after one-lung ventilation</time_frame>
    <description>Primary outcome is arterial partial pressure of oxygen 30 min after one-lung ventilation during thoracic surgery in propofol and desflurane groups.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>recovery slope</measure>
    <time_frame>30 min after one-lung ventilation</time_frame>
    <description>Secondary outcome is recovery slope measured by vascular occlusion test 30 min after one-lung ventilation during thoracic surgery in propofol and desflurane groups.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>blood pressure</measure>
    <time_frame>30 min after one-lung ventilation</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">104</enrollment>
  <condition>Mechanical Ventilation Complication</condition>
  <arm_group>
    <arm_group_label>propofol</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Propofol is used as a maintenance anesthetic to patients in the propofol group. Intervention: propofol infusion by target-controlled infusion for maintaining anesthesia propofol (Fresofol MCT 2%) target effect site concentration: 4~5 mcg/ml, during general anesthesia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>desflurane</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Desflurane is used as a maintenance anesthetic to patients in the desflurane group.&#xD;
Intervention: Desflurane administration for maintaining anesthesia desflurane (Suprane) inhalation as 6~8 vol% during general anesthesia</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>propofol</intervention_name>
    <description>Patients are randomized to receive intravenous anesthetic (propofol) or inhalational anesthetic (desflurane) as a maintenance anesthetic.</description>
    <arm_group_label>propofol</arm_group_label>
    <other_name>propofol (Fresofol(R)2 MCT 2%, Fresenius Kabi)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>desflurane</intervention_name>
    <description>Patients are randomized to receive intravenous anesthetic (propofol) or inhalational anesthetic (desflurane) as a maintenance anesthetic.</description>
    <arm_group_label>desflurane</arm_group_label>
    <other_name>desflurane (Suprane(R), Baxter Healthcare)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  undergoing thoracic surgery including one-lung ventilation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  refuse to enroll&#xD;
&#xD;
          -  BMI over 30 kg/m(2)&#xD;
&#xD;
          -  severe obstructive or restrictive lung disease&#xD;
&#xD;
          -  preoperative supplemental oxygen, intubated, or mechanical ventilatory support&#xD;
&#xD;
          -  preoperative arterial partial pressure of oxygen &lt; 60 mmHg&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  history of coronary artery disease&#xD;
&#xD;
          -  preoperative continuous infusion of vasopressor or inotropes&#xD;
&#xD;
          -  cannot undergo vascular occlusion test: anatomical abnormality of both arms, severe&#xD;
             peripheral vascular disease, presence of A-V fistula&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yunseok Jeon, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seoul National University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>110-744</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>July 7, 2014</study_first_submitted>
  <study_first_submitted_qc>July 13, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 16, 2014</study_first_posted>
  <last_update_submitted>October 12, 2016</last_update_submitted>
  <last_update_submitted_qc>October 12, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 13, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>oxygenation</keyword>
  <keyword>microcirculation</keyword>
  <keyword>one-lung ventilation</keyword>
  <keyword>thoracic surgery</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Propofol</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/NCT02191371
org study id: PaO2 & StO2 in OLV
nct id: NCT02191371
lead sponsor: 
has dmc: Yes
One-lung ventilation during thoracic surgery may affect systemic oxygenation and peripheral
      microcirculation by hypoxic pulmonary vasoconstriction. Both intravenous and inhalational
      anesthetics can be used during one-lung ventilation. However, there is still a controversy
      which anesthetic would be more appropriate during one-lung ventilation in the perspective of
      oxygenation and microcirculation. The investigators hypothesized that intravenous and
      inhalational anesthetics may affect oxygenation and microcirculation differently during
      one-lung ventilation.
Patients undergoing thoracic surgery including one-lung ventilation will be randomized to
      receive intravenous (propofol) or inhalational (desflurane) anesthetic.

      Systemic oxygenation can be evaluated by measuring partial pressure of oxygen in arterial
      blood analysis. Microcirculatory parameters can be obtained from vascular occlusion test.
      Among those parameters, recovery slope during vascular occlusion test is known to reflect
      recruitment of microvasculature in response to hypoxic or ischemic insult. In this study, we
      will compare arterial partial pressure of oxygen and recovery slope during one-lung
      ventilation between propofol and desflurane group.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: arterial partial pressure of oxygen
time frame: 30 min after one-lung ventilation
description: Primary outcome is arterial partial pressure of oxygen 30 min after one-lung ventilation during thoracic surgery in propofol and desflurane groups.
measure: recovery slope
time frame: 30 min after one-lung ventilation
description: Secondary outcome is recovery slope measured by vascular occlusion test 30 min after one-lung ventilation during thoracic surgery in propofol and desflurane groups.
measure: blood pressure
time frame: 30 min after one-lung ventilation
arm group label: propofol
arm group type: Experimental
description: Propofol is used as a maintenance anesthetic to patients in the propofol group. Intervention: propofol infusion by target-controlled infusion for maintaining anesthesia propofol (Fresofol MCT 2%) target effect site concentration: 4~5 mcg/ml, during general anesthesia
arm group label: desflurane
arm group type: Experimental
description: Desflurane is used as a maintenance anesthetic to patients in the desflurane group.
Intervention: Desflurane administration for maintaining anesthesia desflurane (Suprane) inhalation as 6~8 vol% during general anesthesia
intervention type: Drug
intervention name: propofol
description: Patients are randomized to receive intravenous anesthetic (propofol) or inhalational anesthetic (desflurane) as a maintenance anesthetic.
arm group label: propofol
other name: propofol (Fresofol(R)2 MCT 2%, Fresenius Kabi)
intervention type: Drug
intervention name: desflurane
description: Patients are randomized to receive intravenous anesthetic (propofol) or inhalational anesthetic (desflurane) as a maintenance anesthetic.
arm group label: desflurane
other name: desflurane (Suprane(R), Baxter Healthcare)
criteria: 
gender: All
minimum age: 20 Years
maximum age: 90 Years
healthy volunteers: No
last name: Yunseok Jeon, PhD
role: Principal Investigator
affiliation: Seoul National University Hospital
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Propofol
mesh term: Desflurane
sharing ipd: No