<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/NCT02966743</url>
  </required_header>
  <id_info>
    <org_study_id>GCIRB2016-293</org_study_id>
    <nct_id>NCT02966743</nct_id>
  </id_info>
  <brief_title>Effect of Sedatives on Regional Cerebral Oxygen Saturation</brief_title>
  <acronym>2</acronym>
  <official_title>Effect of Medazolam or Dexmedetomidine on Regional Cerebral Oxygen Saturation During Spinal Anesthesia in the Elderly Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Gachon University Gil Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Gachon University Gil Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Compare the changes of regional cerebral oxygen saturation during midazolam or&#xD;
      dexmedetomidine sedation for spinal anesthesia in the elderly patients who undergoing femur&#xD;
      surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Compare the changes of regional cerebral oxygen saturation during midazolam or&#xD;
      dexmedetomidine administration (target bispectrl index 75-80) for spinal anesthesia in the&#xD;
      elderly patients over 65 years who undergoing femur surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <start_date>November 2016</start_date>
  <completion_date type="Anticipated">October 2017</completion_date>
  <primary_completion_date type="Anticipated">October 2017</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>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>regional cerebral oxygen saturation</measure>
    <time_frame>1 day</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Cerebral Ischemia-Hypoxia</condition>
  <arm_group>
    <arm_group_label>midazolam</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>administration of midazolam during spinal anesthesia for target bispectral index 75-80</description>
  </arm_group>
  <arm_group>
    <arm_group_label>dexmedetomidine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>administration of dexmedeomidine during spinal anesthesia for target bispectral index 75-80</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Midazolam</intervention_name>
    <description>administration of midazolam during spinal anesthesia for target bispectral index 75-80</description>
    <arm_group_label>midazolam</arm_group_label>
    <other_name>Mida</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexmedetomidine</intervention_name>
    <description>administration of dexmedetomidine during spinal anesthesia for target bispectral index 75-80</description>
    <arm_group_label>dexmedetomidine</arm_group_label>
    <other_name>Dex</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patinets who undergoing femur surgery under spinal anesthesia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  previous cerebrovascular disease, uncontrolled cardiovascular disorder, uncontrolled&#xD;
             pulmonary disease&#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>Youn Yi Jo, MD</last_name>
    <role>Study Director</role>
    <affiliation>Gachon University Gil Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Gachon University Gil Hospital</name>
      <address>
        <city>Incheon</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>November 8, 2016</study_first_submitted>
  <study_first_submitted_qc>November 15, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 17, 2016</study_first_posted>
  <last_update_submitted>February 14, 2019</last_update_submitted>
  <last_update_submitted_qc>February 14, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Gachon University Gil Medical Center</investigator_affiliation>
    <investigator_full_name>Youn Yi Jo</investigator_full_name>
    <investigator_title>Assistant professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brain Ischemia</mesh_term>
    <mesh_term>Cerebral Infarction</mesh_term>
    <mesh_term>Hypoxia-Ischemia, Brain</mesh_term>
    <mesh_term>Ischemia</mesh_term>
    <mesh_term>Hypoxia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Midazolam</mesh_term>
    <mesh_term>Dexmedetomidine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02966743
org study id: GCIRB2016-293
nct id: NCT02966743
lead sponsor: 
has dmc: Yes
Compare the changes of regional cerebral oxygen saturation during midazolam or
      dexmedetomidine sedation for spinal anesthesia in the elderly patients who undergoing femur
      surgery.
Compare the changes of regional cerebral oxygen saturation during midazolam or
      dexmedetomidine administration (target bispectrl index 75-80) for spinal anesthesia in the
      elderly patients over 65 years who undergoing femur surgery.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Double (Investigator, Outcomes Assessor)
measure: regional cerebral oxygen saturation
time frame: 1 day
arm group label: midazolam
arm group type: Experimental
description: administration of midazolam during spinal anesthesia for target bispectral index 75-80
arm group label: dexmedetomidine
arm group type: Active Comparator
description: administration of dexmedeomidine during spinal anesthesia for target bispectral index 75-80
intervention type: Drug
intervention name: Midazolam
description: administration of midazolam during spinal anesthesia for target bispectral index 75-80
arm group label: midazolam
other name: Mida
intervention type: Drug
intervention name: Dexmedetomidine
description: administration of dexmedetomidine during spinal anesthesia for target bispectral index 75-80
arm group label: dexmedetomidine
other name: Dex
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
last name: Youn Yi Jo, MD
role: Study Director
affiliation: Gachon University Gil Medical Center
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Gachon University Gil Medical Center
investigator full name: Youn Yi Jo
investigator title: Assistant professor
mesh term: Brain Ischemia
mesh term: Cerebral Infarction
mesh term: Hypoxia-Ischemia, Brain
mesh term: Ischemia
mesh term: Hypoxia
mesh term: Midazolam
mesh term: Dexmedetomidine
sharing ipd: Undecided