<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/NCT03033693</url>
  </required_header>
  <id_info>
    <org_study_id>2016-1-20410</org_study_id>
    <nct_id>NCT03033693</nct_id>
  </id_info>
  <brief_title>Study of the Depth of Anesthesia on Postoperative Clinical Outcome in Patients With Supratentorial Tumor</brief_title>
  <acronym>DEPTH</acronym>
  <official_title>Study of the Depth of Anesthesia on Postoperative Clinical Outcome in Patients With Supratentorial Tumor</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beijing Tiantan Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Shanxi Provincial People's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Guiyang Jinyang Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Beijing Sanbo Brain Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Second Hospital of Hebei Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Affiliated Hospital of Inner Mongolia Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Chinese PLA General Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Anhui Provincial Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Guangdong 999 Brain Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Zhejiang University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Beijing Tiantan Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Recent studies have shown that deep anesthesia is associated with poor outcome. There is&#xD;
      still lack of randomized controlled trials with large sample size on the effect of depth of&#xD;
      anesthesia on the postoperative outcomes in patients undergoing brain tumor resection. The&#xD;
      investigators are performing a randomized and parallel group trial. The aim of the study is&#xD;
      to determine whether there is a causal relationship between the depth of anesthesia and&#xD;
      postoperative clinical outcome in patients undergoing supratentorial tumor surgery.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2017</start_date>
  <completion_date type="Actual">November 4, 2019</completion_date>
  <primary_completion_date type="Actual">November 4, 2019</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>Other</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Disability-free survival rate</measure>
    <time_frame>Postoperative 30 days</time_frame>
    <description>World Health Organization Disability Assessment Schedule 2.0 Scale will be used to assess the body disability. Disability is defined as a 4-point increasement in the WHODAS score.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1461</enrollment>
  <condition>Anesthesia, Brain Tumor, Supratentorial,Outcome</condition>
  <arm_group>
    <arm_group_label>The deep anesthesia group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>The light anesthesia group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Bispectral index will be targeted at 50</intervention_name>
    <description>The depth of general anesthesia will be monitored by bispectral index (BIS) at 50.</description>
    <arm_group_label>The light anesthesia group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Bispectral index will be targeted at 35</intervention_name>
    <description>The depth of general anesthesia will be monitored by bispectral index (BIS) at 35.</description>
    <arm_group_label>The deep anesthesia group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients scheduled to receive elective supratentorial tumor resection under general&#xD;
             anesthesia from 2017 to 2019 will be recruited in the trial. Inclusion criteria&#xD;
             include ages between 18 and 80 years old, American Society of Anesthesiologists (ASA)&#xD;
             physical status Ⅲ-Ⅳ, surgery duration expected to be equal or more than three hours,&#xD;
             postoperative hospital stay expected to be equal or more than five nights, and&#xD;
             monitoring BIS throughout anesthesia.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who undergo emergency or awake craniotomy surgery, or unable to present the&#xD;
             written consent will be excluded from the trial. The patients whose incision site&#xD;
             conflicts with the placement of BIS electrode on the frontal and temporal lobe will&#xD;
             also be excluded from the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ruquan Han, M.D., Ph.D</last_name>
    <role>Study Chair</role>
    <affiliation>Department of Anesthesiology, Beijing Tian Tan Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Beijing Tian Tan Hospital</name>
      <address>
        <city>Beijing</city>
        <zip>100070</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>January 24, 2017</study_first_submitted>
  <study_first_submitted_qc>January 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 27, 2017</study_first_posted>
  <last_update_submitted>December 29, 2021</last_update_submitted>
  <last_update_submitted_qc>December 29, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 14, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Beijing Tiantan Hospital</investigator_affiliation>
    <investigator_full_name>Ruquan Han</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Supratentorial Neoplasms</mesh_term>
  </condition_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/NCT03033693
org study id: 2016-1-20410
nct id: NCT03033693
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Recent studies have shown that deep anesthesia is associated with poor outcome. There is
      still lack of randomized controlled trials with large sample size on the effect of depth of
      anesthesia on the postoperative outcomes in patients undergoing brain tumor resection. The
      investigators are performing a randomized and parallel group trial. The aim of the study is
      to determine whether there is a causal relationship between the depth of anesthesia and
      postoperative clinical outcome in patients undergoing supratentorial tumor surgery.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Disability-free survival rate
time frame: Postoperative 30 days
description: World Health Organization Disability Assessment Schedule 2.0 Scale will be used to assess the body disability. Disability is defined as a 4-point increasement in the WHODAS score.
arm group label: The deep anesthesia group
arm group type: Other
arm group label: The light anesthesia group
arm group type: Other
intervention type: Other
intervention name: Bispectral index will be targeted at 50
description: The depth of general anesthesia will be monitored by bispectral index (BIS) at 50.
arm group label: The light anesthesia group
intervention type: Other
intervention name: Bispectral index will be targeted at 35
description: The depth of general anesthesia will be monitored by bispectral index (BIS) at 35.
arm group label: The deep anesthesia group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Ruquan Han, M.D., Ph.D
role: Study Chair
affiliation: Department of Anesthesiology, Beijing Tian Tan Hospital
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Beijing Tiantan Hospital
investigator full name: Ruquan Han
investigator title: Professor
mesh term: Supratentorial Neoplasms