<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/NCT03839784</url>
  </required_header>
  <id_info>
    <org_study_id>55169</org_study_id>
    <nct_id>NCT03839784</nct_id>
  </id_info>
  <brief_title>Building a Platform for Precision Anesthesia in the Geriatric Surgical Patient</brief_title>
  <official_title>Building a Platform for Precision Anesthesia in the Geriatric Surgical Patient</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Stanford University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Stanford University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The research team is creating a foundational infrastructure in order to develop a precision&#xD;
      medicine approach for geriatric patients who require surgery with anesthesia. The team plans&#xD;
      to build the first of its kind comprehensive database of demographic and risk factor&#xD;
      questionnaire responses, biobanked blood specimens, intraoperative electroencephalography&#xD;
      (EEG), and inclusive cognitive testing throughout patient interaction starting at the preop&#xD;
      appointment until a year later. This will be used to create a predictive model of&#xD;
      periooperative neurocognitive disorders.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 1, 2020</start_date>
  <completion_date type="Anticipated">August 30, 2024</completion_date>
  <primary_completion_date type="Anticipated">August 30, 2024</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>1 Year</target_duration>
  <primary_outcome>
    <measure>Postoperative Neurocognitive Disorders</measure>
    <time_frame>3 years</time_frame>
    <description>Neurocognitive Assessment Battery</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">250</enrollment>
  <condition>Cognitive Decline</condition>
  <condition>Cognitive Change</condition>
  <condition>Cognitive Impairment</condition>
  <condition>Postoperative Delirium</condition>
  <condition>Anesthesia; Reaction</condition>
  <condition>Anesthesia; Adverse Effect</condition>
  <arm_group>
    <arm_group_label>Neurocognitive Assessment Arm</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>Neurocognition Interventions</intervention_name>
    <description>EEG, Neurocognitive Battery Testing, and Immune Profiles</description>
    <arm_group_label>Neurocognitive Assessment Arm</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Stanford Hospital geriatric patients having surgery.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  At least 65 years old (inclusive)&#xD;
&#xD;
          -  Non cardiac general elective surgery&#xD;
&#xD;
          -  General anesthesia is expected for 2+ hours&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Alzheimer's&#xD;
&#xD;
          -  Dementia&#xD;
&#xD;
          -  Parkinson's&#xD;
&#xD;
          -  History of neurodegenerative diseases&#xD;
&#xD;
          -  Medication for depression (ie. Benzodiazepines)&#xD;
&#xD;
          -  Alcoholism&#xD;
&#xD;
          -  Discretion of PI&#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>David Drover, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Stanford University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Angelica K Pritchard, BS</last_name>
    <phone>650-723-9229</phone>
    <email>apritcha@stanford.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Stanford Medical Center</name>
      <address>
        <city>Stanford</city>
        <state>California</state>
        <zip>94305</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>David R Drover, MD</last_name>
      <phone>650-714-0316</phone>
      <email>ddrover@stanford.edu</email>
    </contact>
    <contact_backup>
      <last_name>R</last_name>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>February 11, 2019</study_first_submitted>
  <study_first_submitted_qc>February 12, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 15, 2019</study_first_posted>
  <last_update_submitted>May 10, 2022</last_update_submitted>
  <last_update_submitted_qc>May 10, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 11, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Stanford University</investigator_affiliation>
    <investigator_full_name>David R. Drover</investigator_full_name>
    <investigator_title>Professor of Anesthesiology</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Emergence Delirium</mesh_term>
    <mesh_term>Cognitive Dysfunction</mesh_term>
  </condition_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/NCT03839784
org study id: 55169
nct id: NCT03839784
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
The research team is creating a foundational infrastructure in order to develop a precision
      medicine approach for geriatric patients who require surgery with anesthesia. The team plans
      to build the first of its kind comprehensive database of demographic and risk factor
      questionnaire responses, biobanked blood specimens, intraoperative electroencephalography
      (EEG), and inclusive cognitive testing throughout patient interaction starting at the preop
      appointment until a year later. This will be used to create a predictive model of
      periooperative neurocognitive disorders.
observational model: Cohort
time perspective: Prospective
measure: Postoperative Neurocognitive Disorders
time frame: 3 years
description: Neurocognitive Assessment Battery
arm group label: Neurocognitive Assessment Arm
intervention type: Combination Product
intervention name: Neurocognition Interventions
description: EEG, Neurocognitive Battery Testing, and Immune Profiles
arm group label: Neurocognitive Assessment Arm
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
last name: David Drover, MD
role: Principal Investigator
affiliation: Stanford University
last name: Angelica K Pritchard, BS
phone: 650-723-9229
email: apritcha@stanford.edu
facility: 
status: Recruiting
contact: 
contact backup: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Stanford University
investigator full name: David R. Drover
investigator title: Professor of Anesthesiology
mesh term: Emergence Delirium
mesh term: Cognitive Dysfunction
sharing ipd: Undecided