<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/NCT01700907</url>
  </required_header>
  <id_info>
    <org_study_id>DES-40-POCD</org_study_id>
    <nct_id>NCT01700907</nct_id>
  </id_info>
  <brief_title>Optimization of Desflurane in Elderly Patients</brief_title>
  <official_title>Optimization of Desflurane in Elderly Patients Compared With Sevoflurane: A Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sapporo Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sapporo Medical University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Various issues had been pointed out when undergoing the anesthesia for elderly patients with&#xD;
      sevoflurane, such as delayed emergence, post-operative trouble with swallowing.&#xD;
&#xD;
      Desflurane, which has a lower blood/gas partition coefficient, is expected to contribute the&#xD;
      better emergence, along with the recent progress on optimization of delivered amount of&#xD;
      anesthesia.&#xD;
&#xD;
      The purpose of this study is to compare the time to emergence in long elderly patient cases&#xD;
      with desflurane or sevoflurane, with the recently developed drug-delivery optimization system&#xD;
      &quot;Aisys®&quot; (GE Healthcare Japan).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The objectives of this study is to compare the time to emergence and quality of recovery in&#xD;
      long elderly patient cases with desflurane or sevoflurane, with the recently developed&#xD;
      drug-delivery optimization system &quot;Aisys®&quot; (GE Healthcare Japan).&#xD;
&#xD;
      Inclusion Criteria:&#xD;
&#xD;
      - Elderly patients (&gt;= 65 yr-old), long operation (&gt; 4hours), abdominal surgery patients&#xD;
&#xD;
      Exclusion Criteria:&#xD;
&#xD;
      - Liver dysfunction, Renal dysfunction, preoperative dementia Neurosurgery patients, Cardiac&#xD;
      surgery patients, obese patients(BMI&gt;35)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">February 2013</completion_date>
  <primary_completion_date type="Actual">February 2013</primary_completion_date>
  <phase>Phase 1/Phase 2</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>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The Time From the End of Anesthesia to Extubation</measure>
    <time_frame>Within 60 minutes after the end of anesthesia</time_frame>
    <description>When surgery ends, the fresh gas flow rate will be increased to 6L/min (100% oxygen). Patients will be asked to open eyes by touching the shoulder, calling the name every 15 seconds. Patients will be applied stimulus every 15 seconds until following commands. Extubation will be performed when the patient is judged to be awake and spontaneous breathing recovery substantially.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The Time From the End of Anesthesia to Eye Opening</measure>
    <time_frame>Within 60 minutes after the end of anesthesia</time_frame>
    <description>When surgery ends, the fresh gas flow rate will be increased to 6L/min (100% oxygen). Patients will be asked to open eyes by touching the shoulder, calling the name every 15 seconds. Patients will be applied stimulus every 15 seconds until following commands. Extubation will be performed when the patient is judged to be awake and spontaneous breathing recovery substantially.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Time From the End of Anesthesia to Following Commands</measure>
    <time_frame>Within 60 minutes after the end of anesthesia</time_frame>
    <description>When surgery ends, the fresh gas flow rate will be increased to 6L/min (100% oxygen). Patients will be asked to open eyes by touching the shoulder, calling the name every 15 seconds. Patients will be applied stimulus every 15 seconds until following commands. Extubation will be performed when the patient is judged to be awake and spontaneous breathing recovery substantially.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognitive Function</measure>
    <time_frame>24 hrs pre and postoperatively</time_frame>
    <description>Cognitive function will be measured by MMSE (Mini-Mental State Examination) at 24hrs pre and postoperatively. Total MMSE score is recorded by interview ranging from 0 (minimum) to 30 (maximum). MMSE score is consisted on 11 subscales, and total MMSE score is simply summation of all the subscale scores. Maximum MMSE score indicates that the patient is excellent for cognitive function. MMSE score under 26 indicated the cognitive dysfunction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Incidence of Postoperative Delirium</measure>
    <time_frame>from 15 minutes to 48 hrs postoperatively</time_frame>
    <description>The incidence of post operative delirium will be measured by Confusion Assessment Method (CAM) at baseline, 15mins, 3hrs, 6hrs, 12hrs, 24hrs, 48hrs postoperatively.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Postoperative Cognitive Dysfunction</condition>
  <arm_group>
    <arm_group_label>group DES</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The patients in this arm will be given the general anesthesia with desflurane and be used the Aysis as the anesthetic machine.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>group SEVO</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The patients in this arm will be given the general anesthesia with sevoflurane and be used the Aysis as the anesthetic machine.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Desflurane</intervention_name>
    <description>The patients in this arm will be given the general anesthesia with desflurane and be used the Aysis as the anesthetic machine.</description>
    <arm_group_label>group DES</arm_group_label>
    <other_name>(2RS)-2-(Difluoromethoxy)-1,1,1,2-tetrafluoroethane</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sevoflurane</intervention_name>
    <description>The patients in this arm will be given the general anesthesia with sevoflurane and be used the Aysis as the anesthetic machine.</description>
    <arm_group_label>group SEVO</arm_group_label>
    <other_name>1,1,1,3,3,3-Hexafluoro-2-(fluoromethoxy)propane</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - Elderly patients (&gt;= 65 yr-old), long operation (&gt; 4hours), abdominal surgery patients&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - Liver dysfunction, Renal dysfunction, preoperative dementia Neurosurgery patients,&#xD;
        Cardiac surgery patients, obese patients(BMI&gt;35)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michiaki Yamakage, M.D.,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sapporo Medical University, School of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sapporo Medical University, School of Medicine</name>
      <address>
        <city>Sappro</city>
        <state>Hokkaido</state>
        <zip>0608556</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>November 2014</verification_date>
  <study_first_submitted>September 30, 2012</study_first_submitted>
  <study_first_submitted_qc>October 2, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 4, 2012</study_first_posted>
  <results_first_submitted>February 26, 2013</results_first_submitted>
  <results_first_submitted_qc>November 25, 2014</results_first_submitted_qc>
  <results_first_posted type="Estimate">November 27, 2014</results_first_posted>
  <last_update_submitted>November 25, 2014</last_update_submitted>
  <last_update_submitted_qc>November 25, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 27, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sapporo Medical University</investigator_affiliation>
    <investigator_full_name>Michiaki Yamakage</investigator_full_name>
    <investigator_title>Optimization of Desflurane in Elderly Patients Compared with Sevoflurane: A Pilot Study</investigator_title>
  </responsible_party>
  <keyword>Postoperative cognitive dysfunction</keyword>
  <keyword>elderly patients</keyword>
  <keyword>long surgery</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Postoperative Cognitive Complications</mesh_term>
    <mesh_term>Cognitive Dysfunction</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>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Twenty patients who were scheduled to undergo general anesthesia in Sapporo Medical University Hospital were enrolled in this study.</recruitment_details>
      <pre_assignment_details>Inclusion criteria were shown as follows: Elderly patients (&gt;= 65 yr-old), long operation (&gt; 4hours), abdominal surgery patients.&#xD;
Exclusion criteria were shown as follows: Liver dysfunction, Renal dysfunction, preoperative dementia Neurosurgery patients, Cardiac surgery patients, obese patients (BMI&gt;35)</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Group DES</title>
          <description>The patients in this arm will be given the general anesthesia with desflurane and be used the Aysis as the anesthetic machine.</description>
        </group>
        <group group_id="P2">
          <title>Group SEVO</title>
          <description>The patients in this arm will be given the general anesthesia with sevoflurane and be used the Aysis as the anesthetic machine.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Group DES</title>
          <description>The patients in this arm will be given the general anesthesia with desflurane and be used the Aysis as the anesthetic machine.</description>
        </group>
        <group group_id="B2">
          <title>Group SEVO</title>
          <description>The patients in this arm will be given the general anesthesia with sevoflurane and be used the Aysis as the anesthetic machine.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="10"/>
            <count group_id="B2" value="10"/>
            <count group_id="B3" value="20"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="74.9" spread="6.0"/>
                    <measurement group_id="B2" value="74.1" spread="6.5"/>
                    <measurement group_id="B3" value="74.5" spread="6.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Japan</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>The Time From the End of Anesthesia to Extubation</title>
        <description>When surgery ends, the fresh gas flow rate will be increased to 6L/min (100% oxygen). Patients will be asked to open eyes by touching the shoulder, calling the name every 15 seconds. Patients will be applied stimulus every 15 seconds until following commands. Extubation will be performed when the patient is judged to be awake and spontaneous breathing recovery substantially.</description>
        <time_frame>Within 60 minutes after the end of anesthesia</time_frame>
        <population>This is a pilot study.</population>
        <group_list>
          <group group_id="O1">
            <title>Group DES</title>
            <description>The patients in this arm will be given the general anesthesia with desflurane and be used the Aysis as the anesthetic machine.</description>
          </group>
          <group group_id="O2">
            <title>Group SEVO</title>
            <description>The patients in this arm will be given the general anesthesia with sevoflurane and be used the Aysis as the anesthetic machine.</description>
          </group>
        </group_list>
        <measure>
          <title>The Time From the End of Anesthesia to Extubation</title>
          <description>When surgery ends, the fresh gas flow rate will be increased to 6L/min (100% oxygen). Patients will be asked to open eyes by touching the shoulder, calling the name every 15 seconds. Patients will be applied stimulus every 15 seconds until following commands. Extubation will be performed when the patient is judged to be awake and spontaneous breathing recovery substantially.</description>
          <population>This is a pilot study.</population>
          <units>second</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="329.0" lower_limit="296.2" upper_limit="453.0"/>
                    <measurement group_id="O2" value="636.0" lower_limit="613.5" upper_limit="918.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Time From the End of Anesthesia to Eye Opening</title>
        <description>When surgery ends, the fresh gas flow rate will be increased to 6L/min (100% oxygen). Patients will be asked to open eyes by touching the shoulder, calling the name every 15 seconds. Patients will be applied stimulus every 15 seconds until following commands. Extubation will be performed when the patient is judged to be awake and spontaneous breathing recovery substantially.</description>
        <time_frame>Within 60 minutes after the end of anesthesia</time_frame>
        <population>This is a pilot study.</population>
        <group_list>
          <group group_id="O1">
            <title>Group DES</title>
            <description>The patients in this arm will be given the general anesthesia with desflurane and be used the Aysis as the anesthetic machine.</description>
          </group>
          <group group_id="O2">
            <title>Group SEVO</title>
            <description>The patients in this arm will be given the general anesthesia with sevoflurane and be used the Aysis as the anesthetic machine.</description>
          </group>
        </group_list>
        <measure>
          <title>The Time From the End of Anesthesia to Eye Opening</title>
          <description>When surgery ends, the fresh gas flow rate will be increased to 6L/min (100% oxygen). Patients will be asked to open eyes by touching the shoulder, calling the name every 15 seconds. Patients will be applied stimulus every 15 seconds until following commands. Extubation will be performed when the patient is judged to be awake and spontaneous breathing recovery substantially.</description>
          <population>This is a pilot study.</population>
          <units>second</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="176.5" lower_limit="166.0" upper_limit="317.0"/>
                    <measurement group_id="O2" value="315.0" lower_limit="277.2" upper_limit="404.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Time From the End of Anesthesia to Following Commands</title>
        <description>When surgery ends, the fresh gas flow rate will be increased to 6L/min (100% oxygen). Patients will be asked to open eyes by touching the shoulder, calling the name every 15 seconds. Patients will be applied stimulus every 15 seconds until following commands. Extubation will be performed when the patient is judged to be awake and spontaneous breathing recovery substantially.</description>
        <time_frame>Within 60 minutes after the end of anesthesia</time_frame>
        <population>This is a pilot study.</population>
        <group_list>
          <group group_id="O1">
            <title>Group DES</title>
            <description>The patients in this arm will be given the general anesthesia with desflurane and be used the Aysis as the anesthetic machine.</description>
          </group>
          <group group_id="O2">
            <title>Group SEVO</title>
            <description>The patients in this arm will be given the general anesthesia with sevoflurane and be used the Aysis as the anesthetic machine.</description>
          </group>
        </group_list>
        <measure>
          <title>The Time From the End of Anesthesia to Following Commands</title>
          <description>When surgery ends, the fresh gas flow rate will be increased to 6L/min (100% oxygen). Patients will be asked to open eyes by touching the shoulder, calling the name every 15 seconds. Patients will be applied stimulus every 15 seconds until following commands. Extubation will be performed when the patient is judged to be awake and spontaneous breathing recovery substantially.</description>
          <population>This is a pilot study.</population>
          <units>second</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="246.5" lower_limit="169.1" upper_limit="357.3"/>
                    <measurement group_id="O2" value="424.0" lower_limit="352.3" upper_limit="553.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cognitive Function</title>
        <description>Cognitive function will be measured by MMSE (Mini-Mental State Examination) at 24hrs pre and postoperatively. Total MMSE score is recorded by interview ranging from 0 (minimum) to 30 (maximum). MMSE score is consisted on 11 subscales, and total MMSE score is simply summation of all the subscale scores. Maximum MMSE score indicates that the patient is excellent for cognitive function. MMSE score under 26 indicated the cognitive dysfunction.</description>
        <time_frame>24 hrs pre and postoperatively</time_frame>
        <population>This is a pilot study</population>
        <group_list>
          <group group_id="O1">
            <title>Group DES</title>
            <description>The patients in this arm will be given the general anesthesia with desflurane and be used the Aysis as the anesthetic machine.</description>
          </group>
          <group group_id="O2">
            <title>Group SEVO</title>
            <description>The patients in this arm will be given the general anesthesia with sevoflurane and be used the Aysis as the anesthetic machine.</description>
          </group>
        </group_list>
        <measure>
          <title>Cognitive Function</title>
          <description>Cognitive function will be measured by MMSE (Mini-Mental State Examination) at 24hrs pre and postoperatively. Total MMSE score is recorded by interview ranging from 0 (minimum) to 30 (maximum). MMSE score is consisted on 11 subscales, and total MMSE score is simply summation of all the subscale scores. Maximum MMSE score indicates that the patient is excellent for cognitive function. MMSE score under 26 indicated the cognitive dysfunction.</description>
          <population>This is a pilot study</population>
          <units>Scores on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>pre-operation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.0" lower_limit="27.0" upper_limit="29.0"/>
                    <measurement group_id="O2" value="28.0" lower_limit="27.5" upper_limit="29.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>post-operation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29.5" lower_limit="28.0" upper_limit="30.0"/>
                    <measurement group_id="O2" value="29.0" lower_limit="28.3" upper_limit="30.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Incidence of Postoperative Delirium</title>
        <description>The incidence of post operative delirium will be measured by Confusion Assessment Method (CAM) at baseline, 15mins, 3hrs, 6hrs, 12hrs, 24hrs, 48hrs postoperatively.</description>
        <time_frame>from 15 minutes to 48 hrs postoperatively</time_frame>
        <population>This is a pilot study.</population>
        <group_list>
          <group group_id="O1">
            <title>Group DES</title>
            <description>The patients in this arm will be given the general anesthesia with desflurane and be used the Aysis as the anesthetic machine.</description>
          </group>
          <group group_id="O2">
            <title>Group SEVO</title>
            <description>The patients in this arm will be given the general anesthesia with sevoflurane and be used the Aysis as the anesthetic machine.</description>
          </group>
        </group_list>
        <measure>
          <title>The Incidence of Postoperative Delirium</title>
          <description>The incidence of post operative delirium will be measured by Confusion Assessment Method (CAM) at baseline, 15mins, 3hrs, 6hrs, 12hrs, 24hrs, 48hrs postoperatively.</description>
          <population>This is a pilot study.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>The adverse event will be evaluated at 24 h after surgery by interviewing.</time_frame>
      <desc>The adverse event is defined as follows: postoperative death, re-operation, hypotension (systolic blood pressure under 80 mmHg), and delirium at 24 h after surgery. If the adverse event occur and recover until 24 h after surgery, the adverse event is not counted. Other adverse event is not assessed.</desc>
      <group_list>
        <group group_id="E1">
          <title>Group DES</title>
          <description>The patients in this arm will be given the general anesthesia with desflurane and be used the Aysis as the anesthetic machine.</description>
        </group>
        <group group_id="E2">
          <title>Group SEVO</title>
          <description>The patients in this arm will be given the general anesthesia with sevoflurane and be used the Aysis as the anesthetic machine.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Michiaki Yamakage</name_or_title>
      <organization>Sapporo Medical University School of Medicine</organization>
      <phone>+81116112111 ext 3568</phone>
      <email>yamakage@sapmed.ac.jp</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01700907
org study id: DES-40-POCD
nct id: NCT01700907
lead sponsor: 
has dmc: Yes
Various issues had been pointed out when undergoing the anesthesia for elderly patients with
      sevoflurane, such as delayed emergence, post-operative trouble with swallowing.

      Desflurane, which has a lower blood/gas partition coefficient, is expected to contribute the
      better emergence, along with the recent progress on optimization of delivered amount of
      anesthesia.

      The purpose of this study is to compare the time to emergence in long elderly patient cases
      with desflurane or sevoflurane, with the recently developed drug-delivery optimization system
      "Aisys®" (GE Healthcare Japan).
The objectives of this study is to compare the time to emergence and quality of recovery in
      long elderly patient cases with desflurane or sevoflurane, with the recently developed
      drug-delivery optimization system "Aisys®" (GE Healthcare Japan).

      Inclusion Criteria:

      - Elderly patients (>= 65 yr-old), long operation (> 4hours), abdominal surgery patients

      Exclusion Criteria:

      - Liver dysfunction, Renal dysfunction, preoperative dementia Neurosurgery patients, Cardiac
      surgery patients, obese patients(BMI>35)
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: The Time From the End of Anesthesia to Extubation
time frame: Within 60 minutes after the end of anesthesia
description: When surgery ends, the fresh gas flow rate will be increased to 6L/min (100% oxygen). Patients will be asked to open eyes by touching the shoulder, calling the name every 15 seconds. Patients will be applied stimulus every 15 seconds until following commands. Extubation will be performed when the patient is judged to be awake and spontaneous breathing recovery substantially.
measure: The Time From the End of Anesthesia to Eye Opening
time frame: Within 60 minutes after the end of anesthesia
description: When surgery ends, the fresh gas flow rate will be increased to 6L/min (100% oxygen). Patients will be asked to open eyes by touching the shoulder, calling the name every 15 seconds. Patients will be applied stimulus every 15 seconds until following commands. Extubation will be performed when the patient is judged to be awake and spontaneous breathing recovery substantially.
measure: The Time From the End of Anesthesia to Following Commands
time frame: Within 60 minutes after the end of anesthesia
description: When surgery ends, the fresh gas flow rate will be increased to 6L/min (100% oxygen). Patients will be asked to open eyes by touching the shoulder, calling the name every 15 seconds. Patients will be applied stimulus every 15 seconds until following commands. Extubation will be performed when the patient is judged to be awake and spontaneous breathing recovery substantially.
measure: Cognitive Function
time frame: 24 hrs pre and postoperatively
description: Cognitive function will be measured by MMSE (Mini-Mental State Examination) at 24hrs pre and postoperatively. Total MMSE score is recorded by interview ranging from 0 (minimum) to 30 (maximum). MMSE score is consisted on 11 subscales, and total MMSE score is simply summation of all the subscale scores. Maximum MMSE score indicates that the patient is excellent for cognitive function. MMSE score under 26 indicated the cognitive dysfunction.
measure: The Incidence of Postoperative Delirium
time frame: from 15 minutes to 48 hrs postoperatively
description: The incidence of post operative delirium will be measured by Confusion Assessment Method (CAM) at baseline, 15mins, 3hrs, 6hrs, 12hrs, 24hrs, 48hrs postoperatively.
arm group label: group DES
arm group type: Active Comparator
description: The patients in this arm will be given the general anesthesia with desflurane and be used the Aysis as the anesthetic machine.
arm group label: group SEVO
arm group type: Active Comparator
description: The patients in this arm will be given the general anesthesia with sevoflurane and be used the Aysis as the anesthetic machine.
intervention type: Drug
intervention name: Desflurane
description: The patients in this arm will be given the general anesthesia with desflurane and be used the Aysis as the anesthetic machine.
arm group label: group DES
other name: (2RS)-2-(Difluoromethoxy)-1,1,1,2-tetrafluoroethane
intervention type: Drug
intervention name: Sevoflurane
description: The patients in this arm will be given the general anesthesia with sevoflurane and be used the Aysis as the anesthetic machine.
arm group label: group SEVO
other name: 1,1,1,3,3,3-Hexafluoro-2-(fluoromethoxy)propane
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
last name: Michiaki Yamakage, M.D.,PhD
role: Principal Investigator
affiliation: Sapporo Medical University, School of Medicine
facility: 
country: Japan
responsible party type: Principal Investigator
investigator affiliation: Sapporo Medical University
investigator full name: Michiaki Yamakage
investigator title: Optimization of Desflurane in Elderly Patients Compared with Sevoflurane: A Pilot Study
mesh term: Postoperative Cognitive Complications
mesh term: Cognitive Dysfunction
mesh term: Sevoflurane
mesh term: Desflurane
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 