xml: <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/NCT05991817</url>
    </required_header>
    <id_info>
      <org_study_id>OAIC: 1328/23</org_study_id>
      <nct_id>NCT05991817</nct_id>
    </id_info>
    <brief_title>Sevoflurane General Anesthetic and Spatial Memory in Humans</brief_title>
    <official_title>Study of the Effect of Sevoflurane General Anesthetic on Spatial Memory in Humans</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Chile</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Chile</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>
        The goal of this observational study is to learn about the effect of general anesthetic on&#xD;
        spatial memory in adults who will undergo to an elective surgery. The main question it aims&#xD;
        to answer is:&#xD;
  &#xD;
        • A surgical event under general anesthesia with sevoflurane transiently impairs spatial&#xD;
        memory in humans and induces an increase in inflammatory cytokines.&#xD;
  &#xD;
        Participants will perform a virtual maze test and plasma samples will be taken before and&#xD;
        after surgery.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Postoperative cognitive dysfunction (POCD) occurs after a surgical event under general&#xD;
        anesthesia and is characterized by a decline in one or more cognitive functions. POCD is&#xD;
        defined as delayed neurocognitive recovery if it takes place within the first 30 days, if it&#xD;
        exceeds that time it is known as postoperative neurocognitive disorder. The pathogenesis of&#xD;
        this dysfunction is not entirely clear. However, the most accepted hypothesis would be&#xD;
        neuroinflammatory, which would take place due to the contribution of inflammatory factors&#xD;
        typical of surgical trauma under general anesthesia, with anesthetics such as sevoflurane.&#xD;
        Consequently, one of the areas most susceptible to this inflammatory environment would be the&#xD;
        hippocampus, a structure responsible for learning and memory. Spatial memory is responsible&#xD;
        for encoding and retrieving information about the environment and spatial orientation. To&#xD;
        confirm this hypothesis, an elective laparoscopic cholecystectomy under general anesthesia&#xD;
        with sevoflurane, plasma measurement of cytokines interleukin-1beta and tumor necrosis&#xD;
        factor-alpha and virtual navigation tests will be performed before and after an elective&#xD;
        laparoscopic cholecystectomy under general anesthesia with sevoflurane, in order to establish&#xD;
        a correlation between the inflammatory component and performance in the virtual navigation&#xD;
        test. The above will allow us to elucidate the possible occurrence of a delayed&#xD;
        neurocognitive recovery related to spatial memory in middle-aged individuals, providing new&#xD;
        background related to an age group that has been little studied, with a non-minor incidence&#xD;
        (30%), where the evident concern arises for being a population exposed to activities or&#xD;
        environments of greater risk, linked to work, sport, driving, among others. This finding will&#xD;
        guide the doctor and the patient to decide or take the necessary safeguards when proceeding&#xD;
        with a surgical intervention in the middle-aged population.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 14, 2023</start_date>
    <completion_date type="Anticipated">August 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">June 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>30 Days</target_duration>
    <primary_outcome>
      <measure>Virtual spatial memory</measure>
      <time_frame>7th day after surgery</time_frame>
      <description>Time to reach the goal</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Interleukin-1beta</measure>
      <time_frame>1st day after surgery</time_frame>
      <description>Interleukin-1beta plasma concentration</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Interleukin-1beta</measure>
      <time_frame>7th day after surgery</time_frame>
      <description>Interleukin-1beta plasma concentration</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Interleukin-1beta</measure>
      <time_frame>30th day after surgery</time_frame>
      <description>Interleukin-1beta plasma concentration</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Tumor necrosis factor alpha</measure>
      <time_frame>1st day after surgery</time_frame>
      <description>Tumor necrosis factor alpha plasma concentration</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Tumor necrosis factor alpha</measure>
      <time_frame>7th day after surgery</time_frame>
      <description>Tumor necrosis factor alpha plasma concentration</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Tumor necrosis factor alpha</measure>
      <time_frame>30th day after surgery</time_frame>
      <description>Tumor necrosis factor alpha plasma concentration</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Virtual spatial memory</measure>
      <time_frame>1st day after surgery</time_frame>
      <description>Time to reach the goal</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Virtual spatial memory</measure>
      <time_frame>30th day after surgery</time_frame>
      <description>Time to reach the goal</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">22</enrollment>
    <condition>Spatial Memory Disorder</condition>
    <arm_group>
      <arm_group_label>Adults 30-50 years</arm_group_label>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Surgery/general anesthesia</intervention_name>
      <description>Adult patients between the ages of 30 and 50 who are to undergo elective surgery under general anesthesia will have their spatial memory tested and interleukin 1beta and alpha tumor necrosis measured before and after surgery.</description>
      <arm_group_label>Adults 30-50 years</arm_group_label>
    </intervention>
    <biospec_retention>Samples Without DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        Plasma samples&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          Adult patients bewteen 30 and 50 years old who will undergo to an elective laparoscopic&#xD;
          surgery of cholecystectomy.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Candidate for elective laparoscopic surgery of cholecystectomy.&#xD;
  &#xD;
            -  Age 30 to 50 years.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Visual or hearing difficulties.&#xD;
  &#xD;
            -  Malignant hyperthermia.&#xD;
  &#xD;
            -  Being treated with centrally acting drugs, such as anxiolytics, antidepressants,&#xD;
               antipsychotics, anticonvulsants, anticholinergics, and first-generation&#xD;
               antihistamines.&#xD;
  &#xD;
            -  Present a disorder of the sphere of neuropsychiatry&#xD;
  &#xD;
            -  Substance abuse disorder.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>30 Years</minimum_age>
      <maximum_age>50 Years</maximum_age>
    </eligibility>
    <overall_official>
      <last_name>Khaleed Etchegaray</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Chile</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Jamileth More, PhD</last_name>
      <role>Study Director</role>
      <affiliation>University of Chile</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Antonello Penna, MD, PhD</last_name>
      <role>Study Director</role>
      <affiliation>University of Chile</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Antonello Penna, MD, PhD</last_name>
      <phone>+56956766623</phone>
      <email>apenna@uchile.cl</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Khaleed Etchegaray</last_name>
      <phone>+56973310929</phone>
      <email>khaleed.etchegaray@gmail.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Centro de Investigación Cínica Avanzada (CICA), Hospital Clinico de la Universidad de Chile</name>
        <address>
          <city>Santiago</city>
          <state>RM</state>
          <zip>7690306</zip>
          <country>Chile</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Hospital Clinico de la Universidad de Chile</name>
        <address>
          <city>Santiago</city>
          <state>RM</state>
          <zip>7690306</zip>
          <country>Chile</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Chile</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 7, 2023</study_first_submitted>
    <study_first_submitted_qc>August 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 15, 2023</study_first_posted>
    <last_update_submitted>August 7, 2023</last_update_submitted>
    <last_update_submitted_qc>August 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Memory Disorders</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>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05991817
  org study id: OAIC: 1328/23
  nct id: NCT05991817
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this observational study is to learn about the effect of general anesthetic on
        spatial memory in adults who will undergo to an elective surgery. The main question it aims
        to answer is:
  
        • A surgical event under general anesthesia with sevoflurane transiently impairs spatial
        memory in humans and induces an increase in inflammatory cytokines.
  
        Participants will perform a virtual maze test and plasma samples will be taken before and
        after surgery.
  Postoperative cognitive dysfunction (POCD) occurs after a surgical event under general
        anesthesia and is characterized by a decline in one or more cognitive functions. POCD is
        defined as delayed neurocognitive recovery if it takes place within the first 30 days, if it
        exceeds that time it is known as postoperative neurocognitive disorder. The pathogenesis of
        this dysfunction is not entirely clear. However, the most accepted hypothesis would be
        neuroinflammatory, which would take place due to the contribution of inflammatory factors
        typical of surgical trauma under general anesthesia, with anesthetics such as sevoflurane.
        Consequently, one of the areas most susceptible to this inflammatory environment would be the
        hippocampus, a structure responsible for learning and memory. Spatial memory is responsible
        for encoding and retrieving information about the environment and spatial orientation. To
        confirm this hypothesis, an elective laparoscopic cholecystectomy under general anesthesia
        with sevoflurane, plasma measurement of cytokines interleukin-1beta and tumor necrosis
        factor-alpha and virtual navigation tests will be performed before and after an elective
        laparoscopic cholecystectomy under general anesthesia with sevoflurane, in order to establish
        a correlation between the inflammatory component and performance in the virtual navigation
        test. The above will allow us to elucidate the possible occurrence of a delayed
        neurocognitive recovery related to spatial memory in middle-aged individuals, providing new
        background related to an age group that has been little studied, with a non-minor incidence
        (30%), where the evident concern arises for being a population exposed to activities or
        environments of greater risk, linked to work, sport, driving, among others. This finding will
        guide the doctor and the patient to decide or take the necessary safeguards when proceeding
        with a surgical intervention in the middle-aged population.
  observational model: Cohort
  time perspective: Prospective
  measure: Virtual spatial memory
  time frame: 7th day after surgery
  description: Time to reach the goal
  measure: Interleukin-1beta
  time frame: 1st day after surgery
  description: Interleukin-1beta plasma concentration
  measure: Interleukin-1beta
  time frame: 7th day after surgery
  description: Interleukin-1beta plasma concentration
  measure: Interleukin-1beta
  time frame: 30th day after surgery
  description: Interleukin-1beta plasma concentration
  measure: Tumor necrosis factor alpha
  time frame: 1st day after surgery
  description: Tumor necrosis factor alpha plasma concentration
  measure: Tumor necrosis factor alpha
  time frame: 7th day after surgery
  description: Tumor necrosis factor alpha plasma concentration
  measure: Tumor necrosis factor alpha
  time frame: 30th day after surgery
  description: Tumor necrosis factor alpha plasma concentration
  measure: Virtual spatial memory
  time frame: 1st day after surgery
  description: Time to reach the goal
  measure: Virtual spatial memory
  time frame: 30th day after surgery
  description: Time to reach the goal
  arm group label: Adults 30-50 years
  intervention type: Procedure
  intervention name: Surgery/general anesthesia
  description: Adult patients between the ages of 30 and 50 who are to undergo elective surgery under general anesthesia will have their spatial memory tested and interleukin 1beta and alpha tumor necrosis measured before and after surgery.
  arm group label: Adults 30-50 years
  Plasma samples
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 30 Years
  maximum age: 50 Years
  last name: Khaleed Etchegaray
  role: Principal Investigator
  affiliation: University of Chile
  last name: Jamileth More, PhD
  role: Study Director
  affiliation: University of Chile
  last name: Antonello Penna, MD, PhD
  role: Study Director
  affiliation: University of Chile
  last name: Antonello Penna, MD, PhD
  phone: +56956766623
  email: apenna@uchile.cl
  last name: Khaleed Etchegaray
  phone: +56973310929
  email: khaleed.etchegaray@gmail.com
  facility: 
  facility: 
  country: Chile
  responsible party type: Sponsor
  mesh term: Memory Disorders
  mesh term: Anesthetics
  sharing ipd: Undecided