<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/NCT02992600</url>
  </required_header>
  <id_info>
    <org_study_id>XYFY2016-KL018-01</org_study_id>
    <nct_id>NCT02992600</nct_id>
  </id_info>
  <brief_title>Postoperative Cognitive Dysfunction: Correlations With Olfactory Dysfunction and Related Gene Changes</brief_title>
  <official_title>Postoperative Cognitive Dysfunction: Correlations With Olfactory Dysfunction and Related Gene Changes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Han Yuan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Xuzhou Medical University</source>
  <brief_summary>
    <textblock>
      To study on the Postoperative Cognitive Dysfunction: Correlations With Olfactory Dysfunction&#xD;
      and Related Gene Changes.To explore whether the olfactory dysfunction could be used as a&#xD;
      predictor of POCD and to provide reference for POCD prevention, early detection and timely&#xD;
      diagnosis and treatment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2016</start_date>
  <completion_date type="Actual">July 2017</completion_date>
  <primary_completion_date type="Actual">July 2017</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>7 Days</target_duration>
  <primary_outcome>
    <measure>the neuropsychological test battery to measure cognitive function</measure>
    <time_frame>1 day before surgery(baseline)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>olfaction test to measure the sense of smell</measure>
    <time_frame>1 day before surgery(baseline)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>the neuropsychological tests to measure cognitive function</measure>
    <time_frame>within 5 to 10 days (average of 7 days) after surgery</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>olfaction test to measure the sense of smell</measure>
    <time_frame>within 5 to 10 days (average of 7 days) after surgery</time_frame>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">300</enrollment>
  <condition>Postoperative Cognitive Dysfunction</condition>
  <arm_group>
    <arm_group_label>study group</arm_group_label>
    <description>300 male and female patients undergoing non-cardiac surgery are enrolled at the Affiliated Hospital of Xuzhou Medical University [Jiangsu China]. Patients will be divided into POCD and non-POCD groups according to the scores of neuropsychological tests.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <description>30 healthy volunteers are enrolled for calculating the Z-scores of study group.</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      blood&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        We included 300 male and female patients undergoing non-cardiac surgery at the Affiliated&#xD;
        Hospital of Xuzhou Medical University and 30 healthy volunteers.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Between 60 to 85 years old;&#xD;
&#xD;
          -  Undergoing non-cardiac and non-neurological surgery under general anesthesia;&#xD;
&#xD;
          -  Expected hospital stay ≥5 days;&#xD;
&#xD;
          -  American Society of Anesthesiologists class I or II.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Mental or neurodegenerative diseases;&#xD;
&#xD;
          -  History of severe trauma or surgery within one year;&#xD;
&#xD;
          -  History of nasal or sinus illness or surgery;&#xD;
&#xD;
          -  Cold or influenza within 3 weeks;&#xD;
&#xD;
          -  Significant history of organ dysfunction;&#xD;
&#xD;
          -  Previous neuropsychological testing;&#xD;
&#xD;
          -  Difficulty to perform tests (including severe visual or auditory disorders);&#xD;
&#xD;
          -  Mini-Mental State Examination (MMSE) &lt;24 points, &lt;20 points if the participant only&#xD;
             attended elementary school, or &lt;17 points if the participant did not go to school.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Department of Anesthesia of the Affiliated Hospital of Xuzhou Medical University</name>
      <address>
        <city>Xuzhou</city>
        <state>Jiangsu</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>December 2, 2016</study_first_submitted>
  <study_first_submitted_qc>December 10, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 14, 2016</study_first_posted>
  <last_update_submitted>July 19, 2022</last_update_submitted>
  <last_update_submitted_qc>July 19, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 25, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Xuzhou Medical University</investigator_affiliation>
    <investigator_full_name>Han Yuan</investigator_full_name>
    <investigator_title>Physician in Anesthesiology</investigator_title>
  </responsible_party>
  <keyword>non-cardiac surgery</keyword>
  <keyword>Postoperative Cognitive Dysfunction</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Postoperative Cognitive Complications</mesh_term>
    <mesh_term>Cognitive Dysfunction</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>within six months after the trial complete</ipd_description>
  </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/NCT02992600
org study id: XYFY2016-KL018-01
nct id: NCT02992600
lead sponsor: 
To study on the Postoperative Cognitive Dysfunction: Correlations With Olfactory Dysfunction
      and Related Gene Changes.To explore whether the olfactory dysfunction could be used as a
      predictor of POCD and to provide reference for POCD prevention, early detection and timely
      diagnosis and treatment.
observational model: Cohort
time perspective: Prospective
measure: the neuropsychological test battery to measure cognitive function
time frame: 1 day before surgery(baseline)
measure: olfaction test to measure the sense of smell
time frame: 1 day before surgery(baseline)
measure: the neuropsychological tests to measure cognitive function
time frame: within 5 to 10 days (average of 7 days) after surgery
measure: olfaction test to measure the sense of smell
time frame: within 5 to 10 days (average of 7 days) after surgery
arm group label: study group
description: 300 male and female patients undergoing non-cardiac surgery are enrolled at the Affiliated Hospital of Xuzhou Medical University [Jiangsu China]. Patients will be divided into POCD and non-POCD groups according to the scores of neuropsychological tests.
arm group label: control group
description: 30 healthy volunteers are enrolled for calculating the Z-scores of study group.
blood
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 60 Years
maximum age: 85 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: China
responsible party type: Sponsor-Investigator
investigator affiliation: Xuzhou Medical University
investigator full name: Han Yuan
investigator title: Physician in Anesthesiology
mesh term: Postoperative Cognitive Complications
mesh term: Cognitive Dysfunction
sharing ipd: Yes
ipd description: within six months after the trial complete