<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/NCT04421872</url>
  </required_header>
  <id_info>
    <org_study_id>general anesthesia and POCD</org_study_id>
    <nct_id>NCT04421872</nct_id>
  </id_info>
  <brief_title>The Disorder of Circadian Clock Gene and Early Cognitive Dysfunction After General Anesthesia</brief_title>
  <official_title>The Relationship Between the Disorder of Circadian Clock Gene and Early Cognitive Dysfunction After General Anesthesia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shengjing Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shengjing Hospital</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Postoperative cognitive dysfunction (POCD) is a common postoperative complication in patients&#xD;
      aged 65 and over, which refers to cognitive function changes such as memory decline and&#xD;
      attention deficit after anesthesia and surgery. In severe cases, personality changes and&#xD;
      social behavior decline may also occur, resulting in irreversible cognitive&#xD;
      impairment.Previous studies have suggested that cognitive dysfunction after general&#xD;
      anesthesia is linked to a genetic disorder of the body clock.Exosomes are cellular forms of&#xD;
      cellular microvesicles containing complex RNA and proteins.Exosomes can mediate the&#xD;
      expression of genes in the late transcriptional period of the clock system, and directly or&#xD;
      indirectly participate in the negative regulation of rhythm expression of minute control&#xD;
      genes, playing an important role in the intercellular circadian rhythm information output&#xD;
      pathway.Rhythm disorders in the core biological clock system of urinary exosomes and the&#xD;
      clock control genes related to kidney can early indicate circadian rhythm changes in the core&#xD;
      biological clock system.The sorting and detection of urinary exosome clock information&#xD;
      materials in patients has the advantages of easy access, continuous monitoring, early&#xD;
      diagnosis and less damage, making urinary exosome a biomarker for the diagnosis and&#xD;
      monitoring of circadian rhythm of a good kidney biological clock system.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">July 1, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">July 31, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Neurocognitive testing</measure>
    <time_frame>one day before the surgery</time_frame>
    <description>Neurocognitive testing was performed preoperatively and 6 weeks postoperatively, followed up 1 and 3 years postoperatively.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Neurocognitive testing</measure>
    <time_frame>6 weeks after surgery</time_frame>
    <description>Neurocognitive testing was performed preoperatively and 6 weeks postoperatively, followed up 1 and 3 years postoperatively.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Neurocognitive testing</measure>
    <time_frame>1 year after surgery</time_frame>
    <description>Neurocognitive testing was performed preoperatively and 6 weeks postoperatively, followed up 1 and 3 years postoperatively.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Neurocognitive testing</measure>
    <time_frame>3 years after surgery</time_frame>
    <description>Neurocognitive testing was performed preoperatively and 6 weeks postoperatively, followed up 1 and 3 years postoperatively.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Core clock gene and kidney clock control gene detection</measure>
    <time_frame>at the end of surgery</time_frame>
    <description>The urine exosomes were extracted by overspeed centrifugation method. The mRNA ( messenger ribonucleic acid) expression results of the core heart clock gene and the renal bell control genes in the urinary exosomes were detected by timing and quantitative PCR(Polymerase Chain Reaction) and the rhythm was analyzed</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Blood samples and Apolipoprotein E genotyping</measure>
    <time_frame>at the end of surgery</time_frame>
    <description>peripheral blood was collected from each patient for apolipoprotein E genotyping.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">1000</enrollment>
  <condition>Postoperative Delirium</condition>
  <condition>General Anesthesia</condition>
  <condition>Exosomes</condition>
  <condition>Clock Gene</condition>
  <condition>Circadian Rhythm Disorders</condition>
  <arm_group>
    <arm_group_label>General anesthesia Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>receiving general anesthesia</intervention_name>
    <description>patients receiving surgery under general anesthesia</description>
    <arm_group_label>General anesthesia Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients whose age ≥ 18 years old and &lt;90 years of preoperative sleep disorder;&#xD;
&#xD;
          -  Primary cancer patients who had not received any radiotherapy or chemotherapy before&#xD;
             surgery;&#xD;
&#xD;
          -  Surgeries expected to be performed under general anesthesia after ≧3 hours&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  a history of schizophrenia, epilepsy, Parkinson's disease, or myasthenia gravis;&#xD;
&#xD;
          -  inability to communicate due to coma, severe dementia, language impairment or serious&#xD;
             illness;&#xD;
&#xD;
          -  critically ill (preoperative ASA (American Society of Anesthesiologists)&gt;III),&#xD;
             Childe-Pugh C or severe renal insufficiency (preoperative dialysis);&#xD;
&#xD;
          -  Neurosurgery.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Junchao Zhu</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shengjing Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Junchao Zhu</last_name>
    <phone>18940257257</phone>
    <email>zhujunchao1@hotmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Junchao Zhu</name>
      <address>
        <city>Shenyang</city>
        <zip>110004</zip>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Junchao Zhu</last_name>
      <phone>18940257257</phone>
      <phone_ext>18940257257</phone_ext>
      <email>zhujunchao1@hotmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 4, 2020</study_first_submitted>
  <study_first_submitted_qc>June 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>June 4, 2020</last_update_submitted>
  <last_update_submitted_qc>June 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shengjing Hospital</investigator_affiliation>
    <investigator_full_name>Yanchao Yang</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <keyword>Postoperative Delirium</keyword>
  <keyword>general anesthesia</keyword>
  <keyword>Exosomes</keyword>
  <keyword>clock gene</keyword>
  <keyword>Circadian Rhythm Disorders</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Delirium</mesh_term>
    <mesh_term>Emergence Delirium</mesh_term>
    <mesh_term>Chronobiology Disorders</mesh_term>
    <mesh_term>Cognitive Dysfunction</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anesthetics</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT04421872
org study id: general anesthesia and POCD
nct id: NCT04421872
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Postoperative cognitive dysfunction (POCD) is a common postoperative complication in patients
      aged 65 and over, which refers to cognitive function changes such as memory decline and
      attention deficit after anesthesia and surgery. In severe cases, personality changes and
      social behavior decline may also occur, resulting in irreversible cognitive
      impairment.Previous studies have suggested that cognitive dysfunction after general
      anesthesia is linked to a genetic disorder of the body clock.Exosomes are cellular forms of
      cellular microvesicles containing complex RNA and proteins.Exosomes can mediate the
      expression of genes in the late transcriptional period of the clock system, and directly or
      indirectly participate in the negative regulation of rhythm expression of minute control
      genes, playing an important role in the intercellular circadian rhythm information output
      pathway.Rhythm disorders in the core biological clock system of urinary exosomes and the
      clock control genes related to kidney can early indicate circadian rhythm changes in the core
      biological clock system.The sorting and detection of urinary exosome clock information
      materials in patients has the advantages of easy access, continuous monitoring, early
      diagnosis and less damage, making urinary exosome a biomarker for the diagnosis and
      monitoring of circadian rhythm of a good kidney biological clock system.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Neurocognitive testing
time frame: one day before the surgery
description: Neurocognitive testing was performed preoperatively and 6 weeks postoperatively, followed up 1 and 3 years postoperatively.
measure: Neurocognitive testing
time frame: 6 weeks after surgery
description: Neurocognitive testing was performed preoperatively and 6 weeks postoperatively, followed up 1 and 3 years postoperatively.
measure: Neurocognitive testing
time frame: 1 year after surgery
description: Neurocognitive testing was performed preoperatively and 6 weeks postoperatively, followed up 1 and 3 years postoperatively.
measure: Neurocognitive testing
time frame: 3 years after surgery
description: Neurocognitive testing was performed preoperatively and 6 weeks postoperatively, followed up 1 and 3 years postoperatively.
measure: Core clock gene and kidney clock control gene detection
time frame: at the end of surgery
description: The urine exosomes were extracted by overspeed centrifugation method. The mRNA ( messenger ribonucleic acid) expression results of the core heart clock gene and the renal bell control genes in the urinary exosomes were detected by timing and quantitative PCR(Polymerase Chain Reaction) and the rhythm was analyzed
measure: Blood samples and Apolipoprotein E genotyping
time frame: at the end of surgery
description: peripheral blood was collected from each patient for apolipoprotein E genotyping.
arm group label: General anesthesia Group
arm group type: Experimental
arm group label: Healthy control group
arm group type: No Intervention
intervention type: Other
intervention name: receiving general anesthesia
description: patients receiving surgery under general anesthesia
arm group label: General anesthesia Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Junchao Zhu
role: Principal Investigator
affiliation: Shengjing Hospital
last name: Junchao Zhu
phone: 18940257257
email: zhujunchao1@hotmail.com
facility: 
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Shengjing Hospital
investigator full name: Yanchao Yang
investigator title: Principal investigator
mesh term: Delirium
mesh term: Emergence Delirium
mesh term: Chronobiology Disorders
mesh term: Cognitive Dysfunction
mesh term: Anesthetics
sharing ipd: No