<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/NCT02212340</url>
  </required_header>
  <id_info>
    <org_study_id>3-2014-0104</org_study_id>
    <nct_id>NCT02212340</nct_id>
  </id_info>
  <brief_title>Comparison Between Propofol-remifentanil Total Intravenous Anesthesia and Desflurane-remifentanil Balanced Anesthesia With Regard to Post-anesthetic Functional Recovery Measured With QoR-40 in Vitrectomy</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yonsei University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yonsei University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Total intravenous anesthesia (TIVA) and inhalation anesthesia are both widely and safely&#xD;
      used, and there are many clinical trials comparing these on various aspects of anesthesia.&#xD;
      However, there have not been studies comparing the quality of recovery from the different&#xD;
      methods of general anesthesia in vitrectomy. In this study, the investigators compare the&#xD;
      functional recovery after general anesthesia in TIVA and inhalation anesthesia with QoR-40&#xD;
      questionnaire in vitrectomy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">March 2016</completion_date>
  <primary_completion_date type="Actual">January 2016</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>QoR-40 score</measure>
    <time_frame>at 6 hours later after surgery</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">84</enrollment>
  <condition>Vitrectomy Operation Under General Anesthesia</condition>
  <arm_group>
    <arm_group_label>TIVA group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Anesthesia is maintained with fresofol and remifentanil</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Des group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Anesthesia is maintained with desflurane and remifentanil</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>fresofol and remifentanil</intervention_name>
    <description>Anesthesia is maintained with fresofol and remifentanil in TIVA group or with desflurane and remifentanil in Des group according to randomly allocated group.</description>
    <arm_group_label>TIVA group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>desflurane and remifentanil</intervention_name>
    <description>Anesthesia is maintained with fresofol and remifentanil in TIVA group or with desflurane and remifentanil in Des group according to randomly allocated group.</description>
    <arm_group_label>Des group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients (20-80 years old) scheduled for vitrectomy surgery undergoing general&#xD;
             anesthesia.&#xD;
&#xD;
          2. ASA 1-3&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with allergy to anesthetic agents&#xD;
&#xD;
          2. Anticipated difficult airway&#xD;
&#xD;
          3. BMI &gt; 30 kg/m2&#xD;
&#xD;
          4. Chronic obstructive pulmonary disease&#xD;
&#xD;
          5. Heart failure 6. Unstable angina&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Gangnam Severance Hospital, Yonsei University College of Medicine</name>
      <address>
        <city>Seoul</city>
        <zip>120-752</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>September 2016</verification_date>
  <study_first_submitted>August 6, 2014</study_first_submitted>
  <study_first_submitted_qc>August 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 8, 2014</study_first_posted>
  <last_update_submitted>September 26, 2016</last_update_submitted>
  <last_update_submitted_qc>September 26, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 27, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>propofol</keyword>
  <keyword>desflurane</keyword>
  <keyword>quality of recovery</keyword>
  <keyword>vitrectomy</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Remifentanil</mesh_term>
    <mesh_term>Desflurane</mesh_term>
    <mesh_term>Propofol</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02212340
org study id: 3-2014-0104
nct id: NCT02212340
lead sponsor: 
has dmc: No
Total intravenous anesthesia (TIVA) and inhalation anesthesia are both widely and safely
      used, and there are many clinical trials comparing these on various aspects of anesthesia.
      However, there have not been studies comparing the quality of recovery from the different
      methods of general anesthesia in vitrectomy. In this study, the investigators compare the
      functional recovery after general anesthesia in TIVA and inhalation anesthesia with QoR-40
      questionnaire in vitrectomy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Investigator)
measure: QoR-40 score
time frame: at 6 hours later after surgery
arm group label: TIVA group
arm group type: Experimental
description: Anesthesia is maintained with fresofol and remifentanil
arm group label: Des group
arm group type: Active Comparator
description: Anesthesia is maintained with desflurane and remifentanil
intervention type: Drug
intervention name: fresofol and remifentanil
description: Anesthesia is maintained with fresofol and remifentanil in TIVA group or with desflurane and remifentanil in Des group according to randomly allocated group.
arm group label: TIVA group
intervention type: Drug
intervention name: desflurane and remifentanil
description: Anesthesia is maintained with fresofol and remifentanil in TIVA group or with desflurane and remifentanil in Des group according to randomly allocated group.
arm group label: Des group
criteria: 
gender: All
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Remifentanil
mesh term: Desflurane
mesh term: Propofol