<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/NCT02252445</url>
  </required_header>
  <id_info>
    <org_study_id>CRBDPPFSEVO</org_study_id>
    <nct_id>NCT02252445</nct_id>
  </id_info>
  <brief_title>Propofol and Sevoflurane for Catheter-Related Bladder Discomfort</brief_title>
  <official_title>Effect of Propofol and Sevoflurane on Postoperative Catheter-Related Bladder Discomfort</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>
      The investigators want to evaluate the efficacy of the propofol and sevoflurane for the&#xD;
      prevention of catheter-related bladder discomfort.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The mechanism of catheter-related bladder discomfort is thought to be related to the&#xD;
      muscarinic receptor. Propofol and desflurane are most widely used as an anesthetic agent.&#xD;
      Propofol and desflurane are known to block the muscarinic receptor in different ways.&#xD;
&#xD;
      The investigators want to evaluate the efficacy of the propofol and sevoflurane for the&#xD;
      prevention of catheter-related bladder discomfort.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2014</start_date>
  <completion_date type="Actual">January 2015</completion_date>
  <primary_completion_date type="Actual">January 2015</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Catheter-related Bladder Discomfort</measure>
    <time_frame>1 hour postoperatively</time_frame>
    <description>Catheter-related bladder discomfort will be measured at 1 hour postoperatively (0:none, 1:mild, 2:moderate, 3:severe). Patients with score &gt;0 will be counted.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Catheter-related Bladder Discomfort</measure>
    <time_frame>0, 6 and 24 hour postoperatively</time_frame>
    <description>Catheter-related bladder discomfort will be measured at 1 hour postoperatively (0:none, 1:mild, 2:moderate, 3:severe). Patients with score &gt;0 will be counted.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hemodynamic Parameters</measure>
    <time_frame>0, 1, 5, 10 minute postoperatively</time_frame>
    <description>Mean blood pressure and heart rate will be measured at 0, 1, 5, 10 minute postoperatively. Measurement at 10 minute means Mean blood pressure and heart rate at the admission of post-anesthetic care unit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nausea</measure>
    <time_frame>0, 1, 6 and 24 hour postoperatively</time_frame>
    <description>Nausea will be measured at 0, 1, 6 and 24 hour postoperatively.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vomiting</measure>
    <time_frame>0, 1, 6 and 24 hour postoperatively</time_frame>
    <description>Vomiting will be measured at 0, 1, 6 and 24 hour postoperatively.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dry Mouth</measure>
    <time_frame>0, 1, 6 and 24 hour postoperatively</time_frame>
    <description>Dry mouth will be measured at 0, 1, 6 and 24 hour postoperatively.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Flushing</measure>
    <time_frame>0, 1, 6 and 24 hour postoperatively</time_frame>
    <description>Flushing will be measured at 0, 1, 6 and 24 hour postoperatively.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blurred Vision</measure>
    <time_frame>0, 1, 6 and 24 hour postoperatively</time_frame>
    <description>Blurred vision will be measured at 0, 1, 6 and 24 hour postoperatively.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dizziness</measure>
    <time_frame>0, 1, 6 and 24 hour postoperatively</time_frame>
    <description>Dizziness will be measured at 0, 1, 6 and 24 hour postoperatively.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Analgesics</measure>
    <time_frame>0, 1, 6 and 24 hour postoperatively</time_frame>
    <description>The amount of analgesics will be measured at 0, 1, 6 and 24 hour postoperatively.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">82</enrollment>
  <condition>Catheter Site Discomfort</condition>
  <condition>Complications</condition>
  <condition>Anesthesia</condition>
  <condition>Urinary Bladder Neoplasms</condition>
  <arm_group>
    <arm_group_label>Propofol</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Propofol will be administered as the anesthetic maintenance agent.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sevoflurane</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Sevoflurane will be administered as the anesthetic maintenance agent.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Propofol</intervention_name>
    <description>Propofol will be administered.</description>
    <arm_group_label>Propofol</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sevoflurane</intervention_name>
    <description>Sevoflurane will be administered.</description>
    <arm_group_label>Sevoflurane</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients scheduled for transurethral bladder excision under general anesthesia&#xD;
&#xD;
          -  ASA I-III&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Foley catheter less than 18 Fr.&#xD;
&#xD;
          -  Patients with obstruction of urinary tract&#xD;
&#xD;
          -  Patients with neurogenic bladder&#xD;
&#xD;
          -  Patients with severe obesity&#xD;
&#xD;
          -  Patients with neurologic disorder&#xD;
&#xD;
          -  Patients with chronic pain&#xD;
&#xD;
          -  Patients with allergic history to propofol or sevoflurane&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Seolu National University of Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 26, 2014</study_first_submitted>
  <study_first_submitted_qc>September 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 30, 2014</study_first_posted>
  <results_first_submitted>May 2, 2016</results_first_submitted>
  <results_first_submitted_qc>July 20, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">September 1, 2016</results_first_posted>
  <last_update_submitted>July 20, 2016</last_update_submitted>
  <last_update_submitted_qc>July 20, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 1, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urinary Bladder Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Propofol</mesh_term>
    <mesh_term>Sevoflurane</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Propofol</title>
          <description>Propofol will be administered as the anesthetic maintenance agent.&#xD;
Propofol: Propofol will be administered.</description>
        </group>
        <group group_id="P2">
          <title>Sevoflurane</title>
          <description>Sevoflurane will be administered as the anesthetic maintenance agent.&#xD;
Sevoflurane: Sevoflurane will be administered.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="41"/>
                <participants group_id="P2" count="41"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="41"/>
                <participants group_id="P2" count="41"/>
              </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>Propofol</title>
          <description>Propofol will be administered as the anesthetic maintenance agent.&#xD;
Propofol: Propofol will be administered.</description>
        </group>
        <group group_id="B2">
          <title>Sevoflurane</title>
          <description>Sevoflurane will be administered as the anesthetic maintenance agent.&#xD;
Sevoflurane: Sevoflurane will be administered.</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="41"/>
            <count group_id="B2" value="41"/>
            <count group_id="B3" value="82"/>
          </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="19"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="38"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="44"/>
                  </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="9"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="20"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="32"/>
                    <measurement group_id="B2" value="30"/>
                    <measurement group_id="B3" value="62"/>
                  </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>Korea, Republic of</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="41"/>
                    <measurement group_id="B2" value="41"/>
                    <measurement group_id="B3" value="82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Catheter-related Bladder Discomfort</title>
        <description>Catheter-related bladder discomfort will be measured at 1 hour postoperatively (0:none, 1:mild, 2:moderate, 3:severe). Patients with score &gt;0 will be counted.</description>
        <time_frame>1 hour postoperatively</time_frame>
        <population>Patients with score &gt;0 were counted.</population>
        <group_list>
          <group group_id="O1">
            <title>Propofol</title>
            <description>Propofol will be administered as the anesthetic maintenance agent.&#xD;
Propofol: Propofol will be administered.</description>
          </group>
          <group group_id="O2">
            <title>Sevoflurane</title>
            <description>Sevoflurane will be administered as the anesthetic maintenance agent.&#xD;
Sevoflurane: Sevoflurane will be administered.</description>
          </group>
        </group_list>
        <measure>
          <title>Catheter-related Bladder Discomfort</title>
          <description>Catheter-related bladder discomfort will be measured at 1 hour postoperatively (0:none, 1:mild, 2:moderate, 3:severe). Patients with score &gt;0 will be counted.</description>
          <population>Patients with score &gt;0 were counted.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="41"/>
                <count group_id="O2" value="41"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35"/>
                    <measurement group_id="O2" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Catheter-related Bladder Discomfort</title>
        <description>Catheter-related bladder discomfort will be measured at 1 hour postoperatively (0:none, 1:mild, 2:moderate, 3:severe). Patients with score &gt;0 will be counted.</description>
        <time_frame>0, 6 and 24 hour postoperatively</time_frame>
        <population>Patients with score &gt;0 will be counted.</population>
        <group_list>
          <group group_id="O1">
            <title>Propofol</title>
            <description>Propofol will be administered as the anesthetic maintenance agent.&#xD;
Propofol: Propofol will be administered.</description>
          </group>
          <group group_id="O2">
            <title>Sevoflurane</title>
            <description>Sevoflurane will be administered as the anesthetic maintenance agent.&#xD;
Sevoflurane: Sevoflurane will be administered.</description>
          </group>
        </group_list>
        <measure>
          <title>Catheter-related Bladder Discomfort</title>
          <description>Catheter-related bladder discomfort will be measured at 1 hour postoperatively (0:none, 1:mild, 2:moderate, 3:severe). Patients with score &gt;0 will be counted.</description>
          <population>Patients with score &gt;0 will be counted.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="41"/>
                <count group_id="O2" value="41"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38"/>
                    <measurement group_id="O2" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Hemodynamic Parameters</title>
        <description>Mean blood pressure and heart rate will be measured at 0, 1, 5, 10 minute postoperatively. Measurement at 10 minute means Mean blood pressure and heart rate at the admission of post-anesthetic care unit.</description>
        <time_frame>0, 1, 5, 10 minute postoperatively</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Propofol</title>
            <description>Propofol will be administered as the anesthetic maintenance agent.&#xD;
Propofol: Propofol will be administered.</description>
          </group>
          <group group_id="O2">
            <title>Sevoflurane</title>
            <description>Sevoflurane will be administered as the anesthetic maintenance agent.&#xD;
Sevoflurane: Sevoflurane will be administered.</description>
          </group>
        </group_list>
        <measure>
          <title>Hemodynamic Parameters</title>
          <description>Mean blood pressure and heart rate will be measured at 0, 1, 5, 10 minute postoperatively. Measurement at 10 minute means Mean blood pressure and heart rate at the admission of post-anesthetic care unit.</description>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="41"/>
                <count group_id="O2" value="41"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90" spread="24"/>
                    <measurement group_id="O2" value="88" spread="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Nausea</title>
        <description>Nausea will be measured at 0, 1, 6 and 24 hour postoperatively.</description>
        <time_frame>0, 1, 6 and 24 hour postoperatively</time_frame>
        <population>Patients with nausea were counted.</population>
        <group_list>
          <group group_id="O1">
            <title>Propofol</title>
            <description>Propofol will be administered as the anesthetic maintenance agent.&#xD;
Propofol: Propofol will be administered.</description>
          </group>
          <group group_id="O2">
            <title>Sevoflurane</title>
            <description>Sevoflurane will be administered as the anesthetic maintenance agent.&#xD;
Sevoflurane: Sevoflurane will be administered.</description>
          </group>
        </group_list>
        <measure>
          <title>Nausea</title>
          <description>Nausea will be measured at 0, 1, 6 and 24 hour postoperatively.</description>
          <population>Patients with nausea were counted.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="41"/>
                <count group_id="O2" value="41"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Vomiting</title>
        <description>Vomiting will be measured at 0, 1, 6 and 24 hour postoperatively.</description>
        <time_frame>0, 1, 6 and 24 hour postoperatively</time_frame>
        <population>Patients with vomiting were counted.</population>
        <group_list>
          <group group_id="O1">
            <title>Propofol</title>
            <description>Propofol will be administered as the anesthetic maintenance agent.&#xD;
Propofol: Propofol will be administered.</description>
          </group>
          <group group_id="O2">
            <title>Sevoflurane</title>
            <description>Sevoflurane will be administered as the anesthetic maintenance agent.&#xD;
Sevoflurane: Sevoflurane will be administered.</description>
          </group>
        </group_list>
        <measure>
          <title>Vomiting</title>
          <description>Vomiting will be measured at 0, 1, 6 and 24 hour postoperatively.</description>
          <population>Patients with vomiting were counted.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="41"/>
                <count group_id="O2" value="41"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Dry Mouth</title>
        <description>Dry mouth will be measured at 0, 1, 6 and 24 hour postoperatively.</description>
        <time_frame>0, 1, 6 and 24 hour postoperatively</time_frame>
        <population>Patients with dry mouth were counted.</population>
        <group_list>
          <group group_id="O1">
            <title>Propofol</title>
            <description>Propofol will be administered as the anesthetic maintenance agent.&#xD;
Propofol: Propofol will be administered.</description>
          </group>
          <group group_id="O2">
            <title>Sevoflurane</title>
            <description>Sevoflurane will be administered as the anesthetic maintenance agent.&#xD;
Sevoflurane: Sevoflurane will be administered.</description>
          </group>
        </group_list>
        <measure>
          <title>Dry Mouth</title>
          <description>Dry mouth will be measured at 0, 1, 6 and 24 hour postoperatively.</description>
          <population>Patients with dry mouth were counted.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="41"/>
                <count group_id="O2" value="41"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Flushing</title>
        <description>Flushing will be measured at 0, 1, 6 and 24 hour postoperatively.</description>
        <time_frame>0, 1, 6 and 24 hour postoperatively</time_frame>
        <population>Patients with flushing were counted.</population>
        <group_list>
          <group group_id="O1">
            <title>Propofol</title>
            <description>Propofol will be administered as the anesthetic maintenance agent.&#xD;
Propofol: Propofol will be administered.</description>
          </group>
          <group group_id="O2">
            <title>Sevoflurane</title>
            <description>Sevoflurane will be administered as the anesthetic maintenance agent.&#xD;
Sevoflurane: Sevoflurane will be administered.</description>
          </group>
        </group_list>
        <measure>
          <title>Flushing</title>
          <description>Flushing will be measured at 0, 1, 6 and 24 hour postoperatively.</description>
          <population>Patients with flushing were counted.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="41"/>
                <count group_id="O2" value="41"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Blurred Vision</title>
        <description>Blurred vision will be measured at 0, 1, 6 and 24 hour postoperatively.</description>
        <time_frame>0, 1, 6 and 24 hour postoperatively</time_frame>
        <population>Patients with blurred vision were counted.</population>
        <group_list>
          <group group_id="O1">
            <title>Propofol</title>
            <description>Propofol will be administered as the anesthetic maintenance agent.&#xD;
Propofol: Propofol will be administered.</description>
          </group>
          <group group_id="O2">
            <title>Sevoflurane</title>
            <description>Sevoflurane will be administered as the anesthetic maintenance agent.&#xD;
Sevoflurane: Sevoflurane will be administered.</description>
          </group>
        </group_list>
        <measure>
          <title>Blurred Vision</title>
          <description>Blurred vision will be measured at 0, 1, 6 and 24 hour postoperatively.</description>
          <population>Patients with blurred vision were counted.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="41"/>
                <count group_id="O2" value="41"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Dizziness</title>
        <description>Dizziness will be measured at 0, 1, 6 and 24 hour postoperatively.</description>
        <time_frame>0, 1, 6 and 24 hour postoperatively</time_frame>
        <population>Patients with dizziness were counted.</population>
        <group_list>
          <group group_id="O1">
            <title>Propofol</title>
            <description>Propofol will be administered as the anesthetic maintenance agent.&#xD;
Propofol: Propofol will be administered.</description>
          </group>
          <group group_id="O2">
            <title>Sevoflurane</title>
            <description>Sevoflurane will be administered as the anesthetic maintenance agent.&#xD;
Sevoflurane: Sevoflurane will be administered.</description>
          </group>
        </group_list>
        <measure>
          <title>Dizziness</title>
          <description>Dizziness will be measured at 0, 1, 6 and 24 hour postoperatively.</description>
          <population>Patients with dizziness were counted.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="41"/>
                <count group_id="O2" value="41"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Analgesics</title>
        <description>The amount of analgesics will be measured at 0, 1, 6 and 24 hour postoperatively.</description>
        <time_frame>0, 1, 6 and 24 hour postoperatively</time_frame>
        <population>Patients infused with tramadol were counted.</population>
        <group_list>
          <group group_id="O1">
            <title>Propofol</title>
            <description>Propofol will be administered as the anesthetic maintenance agent.&#xD;
Propofol: Propofol will be administered.</description>
          </group>
          <group group_id="O2">
            <title>Sevoflurane</title>
            <description>Sevoflurane will be administered as the anesthetic maintenance agent.&#xD;
Sevoflurane: Sevoflurane will be administered.</description>
          </group>
        </group_list>
        <measure>
          <title>Analgesics</title>
          <description>The amount of analgesics will be measured at 0, 1, 6 and 24 hour postoperatively.</description>
          <population>Patients infused with tramadol were counted.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="41"/>
                <count group_id="O2" value="41"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                    <measurement group_id="O2" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>0 h, 1 h, 6 h, 24 h, 6 month</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Propofol</title>
          <description>Propofol will be administered as the anesthetic maintenance agent.&#xD;
Propofol: Propofol will be administered.</description>
        </group>
        <group group_id="E2">
          <title>Sevoflurane</title>
          <description>Sevoflurane will be administered as the anesthetic maintenance agent.&#xD;
Sevoflurane: Sevoflurane will be administered.</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="41"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="41"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</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="41"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="41"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE 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>Assistant professor</name_or_title>
      <organization>Keimyung university</organization>
      <phone>+821028862876</phone>
      <email>onidori1979@gmail.com</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/NCT02252445
org study id: CRBDPPFSEVO
nct id: NCT02252445
lead sponsor: 
has dmc: Yes
The investigators want to evaluate the efficacy of the propofol and sevoflurane for the
      prevention of catheter-related bladder discomfort.
The mechanism of catheter-related bladder discomfort is thought to be related to the
      muscarinic receptor. Propofol and desflurane are most widely used as an anesthetic agent.
      Propofol and desflurane are known to block the muscarinic receptor in different ways.

      The investigators want to evaluate the efficacy of the propofol and sevoflurane for the
      prevention of catheter-related bladder discomfort.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Catheter-related Bladder Discomfort
time frame: 1 hour postoperatively
description: Catheter-related bladder discomfort will be measured at 1 hour postoperatively (0:none, 1:mild, 2:moderate, 3:severe). Patients with score >0 will be counted.
measure: Catheter-related Bladder Discomfort
time frame: 0, 6 and 24 hour postoperatively
description: Catheter-related bladder discomfort will be measured at 1 hour postoperatively (0:none, 1:mild, 2:moderate, 3:severe). Patients with score >0 will be counted.
measure: Hemodynamic Parameters
time frame: 0, 1, 5, 10 minute postoperatively
description: Mean blood pressure and heart rate will be measured at 0, 1, 5, 10 minute postoperatively. Measurement at 10 minute means Mean blood pressure and heart rate at the admission of post-anesthetic care unit.
measure: Nausea
time frame: 0, 1, 6 and 24 hour postoperatively
description: Nausea will be measured at 0, 1, 6 and 24 hour postoperatively.
measure: Vomiting
time frame: 0, 1, 6 and 24 hour postoperatively
description: Vomiting will be measured at 0, 1, 6 and 24 hour postoperatively.
measure: Dry Mouth
time frame: 0, 1, 6 and 24 hour postoperatively
description: Dry mouth will be measured at 0, 1, 6 and 24 hour postoperatively.
measure: Flushing
time frame: 0, 1, 6 and 24 hour postoperatively
description: Flushing will be measured at 0, 1, 6 and 24 hour postoperatively.
measure: Blurred Vision
time frame: 0, 1, 6 and 24 hour postoperatively
description: Blurred vision will be measured at 0, 1, 6 and 24 hour postoperatively.
measure: Dizziness
time frame: 0, 1, 6 and 24 hour postoperatively
description: Dizziness will be measured at 0, 1, 6 and 24 hour postoperatively.
measure: Analgesics
time frame: 0, 1, 6 and 24 hour postoperatively
description: The amount of analgesics will be measured at 0, 1, 6 and 24 hour postoperatively.
arm group label: Propofol
arm group type: Active Comparator
description: Propofol will be administered as the anesthetic maintenance agent.
arm group label: Sevoflurane
arm group type: Experimental
description: Sevoflurane will be administered as the anesthetic maintenance agent.
intervention type: Drug
intervention name: Propofol
description: Propofol will be administered.
arm group label: Propofol
intervention type: Drug
intervention name: Sevoflurane
description: Sevoflurane will be administered.
arm group label: Sevoflurane
criteria: 
gender: All
minimum age: 19 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Urinary Bladder Neoplasms
mesh term: Propofol
mesh term: Sevoflurane
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 