<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/NCT03774420</url>
  </required_header>
  <id_info>
    <org_study_id>MAST</org_study_id>
    <nct_id>NCT03774420</nct_id>
  </id_info>
  <brief_title>Post Operative Cognitive Dysfunction After Breast Surgery</brief_title>
  <official_title>Post-Operative Cognitive Dysfunction After Breast Surgery: Incidence and Relation With Common Intraoperative Neuromonitoring Data and Concentration of Propofol and Remifentanil Infused With Targeted Controlled Infusion (TCI )in Women With Laryngeal Mask Airway</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Padova</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Padova</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Aim of this trial is to define if Post-Operative Cognitive Dysfunction, detected analyzing&#xD;
      changes between pre-operative and post-operative Neurocognitive Test, relate to concentration&#xD;
      of effector's site concentration of propofol and remifentanil TCI and to the common&#xD;
      intraoperative neuromonitoring values.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Post-Operative Cognitive Dysfunction has not been yet investigated after general anaesthesia&#xD;
      with Targeted-Controlled-Infusion (TCI) and Laryngeal-Mask-Airway (LMA), daily used in the&#xD;
      investigator's Hospital to anesthetize women undergoing breast surgery. Aim of this trial is&#xD;
      to define if neurocognitive tests (Montreal Cognitive Assessment, Trail Making Test A and B,&#xD;
      Digit Span Test) before and after surgery relate to concentrations at effector's site (Ec) of&#xD;
      propofol and remifentanil TCI and the values of Bispectral Index and Entropy monitoring and&#xD;
      Surgical Plethysmographic Index (SPI).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 3, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">July 31, 2023</primary_completion_date>
  <study_type>Observational</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>
  <primary_outcome>
    <measure>Incidence of Post-Operative Cognitive Dysfunction in breast-surgery patients detected with Montreal Cognitive Assessment test</measure>
    <time_frame>Patients will be subjected to Montreael Cognitive Assessment (MOCA) test one day before surgery and 1 day after surgery. This test has a score ranging from 1 (minimum) to 30 (maximum). Better neurocognitve outcome with higher scores)</time_frame>
    <description>Discover incidence of Post-Operative Cognitive decline analyzing changes in Post-Operative Cognitive Dysfunction changes between Pre-operative Montreal Cognitive Assessment test score and post-operative Montreal Cognitive Assessment test score</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of Post-Operative Cognitive Dysfunction in breast-surgery patients detected with Trail Making Test A and B</measure>
    <time_frame>Patients will be subjected to Trail Making Test (TMT) A and B one day before surgery and 1day after surgery. These tests will be evaluated in seconds required to be completed (better neurocognitive outcome with fewer seconds required)</time_frame>
    <description>Discover Post-Operative Cognitive Dysfunction analyzing changes between Pre-operative Trail Making Test A and B test score and post-operative Trail Making Test A and B test score</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of Post-Operative Cognitive Dysfunction in breast-surgery patients detected with Digit Span Test</measure>
    <time_frame>Patients will be subjected to DST one day before surgery and 1 day after surgery. Better neurocognitve outcome with higher scores</time_frame>
    <description>Discover Post-Operative Cognitive Dysfunction analyzing changes between Pre-operative Digit Span Test score and post-operative Digit Span Test test score</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of Post-Operative Delirium in breast-surgery patients</measure>
    <time_frame>Patients will be subjected to CAM-ICU 15 minutes after awakening from anaesthesia. This test can be positive (Delirium present) or negative (Delirium absent)</time_frame>
    <description>Discover Post-Operative Delirium submitting patients Confusion Assessment Method (CAM-ICU) test</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of Post-Operative Cognitive Dysfunction in breast-surgery patients</measure>
    <time_frame>Patients will be subjected to Short Portable Mental Status Questionnaire one day before surgery and 1 day after surgery. Better neurocognitve outcome with lower scores</time_frame>
    <description>Discover Post-Operative Cognitive Dysfunction analyzing changes between Pre-operative Short Portable Mental Status Questionnaire score and post-operative Short Portable Mental Status Questionnaire test score</description>
  </primary_outcome>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Emergence Delirium</condition>
  <condition>Post-Operative Cognitive Dysfunction</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Women subjected to breast surgery in general anaesthesia with Laryngeal-Mask-Airway (LMA)&#xD;
        anesthetized with propofol and remifentanil delivered by Targeted-Controlled-Infusion (TCI)&#xD;
        pumps. Women will be subjected to neurocognitive tests (MOCA, TMT A and B, DST) the day&#xD;
        before surgery and on the first post-operative day. These test will be related to propofol&#xD;
        and remifentanil concentrations at effector site during surgery and awakening, to BIS and&#xD;
        Entropia values and to SPI value.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  General Anaesthesia delivered with Propofol and Remifentanil with Targeted Controlled&#xD;
             Infusion&#xD;
&#xD;
          -  Use of Laryngeal Mask airway&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Neurological pathologies&#xD;
&#xD;
          -  Haemodynamical instability during surgery&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Federico Linassi, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Padova</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Federico Linassi, MD</last_name>
    <phone>049 8754256</phone>
    <email>federico.linassi@studenti.unipd.it</email>
  </overall_contact>
  <location>
    <facility>
      <name>Treviso Regional Hospital</name>
      <address>
        <city>Treviso</city>
        <state>TV</state>
        <zip>31100</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Federico Linassi</last_name>
      <email>linus889@icloud.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>November 15, 2018</study_first_submitted>
  <study_first_submitted_qc>December 12, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 13, 2018</study_first_posted>
  <last_update_submitted>March 10, 2022</last_update_submitted>
  <last_update_submitted_qc>March 10, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 11, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Padova</investigator_affiliation>
    <investigator_full_name>Federico Linassi</investigator_full_name>
    <investigator_title>MD, Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Infusion pumps</keyword>
  <keyword>Intraoperative brain monitoring</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Emergence Delirium</mesh_term>
    <mesh_term>Postoperative Cognitive Complications</mesh_term>
    <mesh_term>Cognitive Dysfunction</mesh_term>
  </condition_browse>
  <!-- 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/NCT03774420
org study id: MAST
nct id: NCT03774420
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Aim of this trial is to define if Post-Operative Cognitive Dysfunction, detected analyzing
      changes between pre-operative and post-operative Neurocognitive Test, relate to concentration
      of effector's site concentration of propofol and remifentanil TCI and to the common
      intraoperative neuromonitoring values.
Post-Operative Cognitive Dysfunction has not been yet investigated after general anaesthesia
      with Targeted-Controlled-Infusion (TCI) and Laryngeal-Mask-Airway (LMA), daily used in the
      investigator's Hospital to anesthetize women undergoing breast surgery. Aim of this trial is
      to define if neurocognitive tests (Montreal Cognitive Assessment, Trail Making Test A and B,
      Digit Span Test) before and after surgery relate to concentrations at effector's site (Ec) of
      propofol and remifentanil TCI and the values of Bispectral Index and Entropy monitoring and
      Surgical Plethysmographic Index (SPI).
observational model: Cohort
time perspective: Prospective
measure: Incidence of Post-Operative Cognitive Dysfunction in breast-surgery patients detected with Montreal Cognitive Assessment test
time frame: Patients will be subjected to Montreael Cognitive Assessment (MOCA) test one day before surgery and 1 day after surgery. This test has a score ranging from 1 (minimum) to 30 (maximum). Better neurocognitve outcome with higher scores)
description: Discover incidence of Post-Operative Cognitive decline analyzing changes in Post-Operative Cognitive Dysfunction changes between Pre-operative Montreal Cognitive Assessment test score and post-operative Montreal Cognitive Assessment test score
measure: Incidence of Post-Operative Cognitive Dysfunction in breast-surgery patients detected with Trail Making Test A and B
time frame: Patients will be subjected to Trail Making Test (TMT) A and B one day before surgery and 1day after surgery. These tests will be evaluated in seconds required to be completed (better neurocognitive outcome with fewer seconds required)
description: Discover Post-Operative Cognitive Dysfunction analyzing changes between Pre-operative Trail Making Test A and B test score and post-operative Trail Making Test A and B test score
measure: Incidence of Post-Operative Cognitive Dysfunction in breast-surgery patients detected with Digit Span Test
time frame: Patients will be subjected to DST one day before surgery and 1 day after surgery. Better neurocognitve outcome with higher scores
description: Discover Post-Operative Cognitive Dysfunction analyzing changes between Pre-operative Digit Span Test score and post-operative Digit Span Test test score
measure: Incidence of Post-Operative Delirium in breast-surgery patients
time frame: Patients will be subjected to CAM-ICU 15 minutes after awakening from anaesthesia. This test can be positive (Delirium present) or negative (Delirium absent)
description: Discover Post-Operative Delirium submitting patients Confusion Assessment Method (CAM-ICU) test
measure: Incidence of Post-Operative Cognitive Dysfunction in breast-surgery patients
time frame: Patients will be subjected to Short Portable Mental Status Questionnaire one day before surgery and 1 day after surgery. Better neurocognitve outcome with lower scores
description: Discover Post-Operative Cognitive Dysfunction analyzing changes between Pre-operative Short Portable Mental Status Questionnaire score and post-operative Short Portable Mental Status Questionnaire test score
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Federico Linassi, MD
role: Principal Investigator
affiliation: University of Padova
last name: Federico Linassi, MD
phone: 049 8754256
email: federico.linassi@studenti.unipd.it
facility: 
status: Recruiting
contact: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: University of Padova
investigator full name: Federico Linassi
investigator title: MD, Principal Investigator
mesh term: Emergence Delirium
mesh term: Postoperative Cognitive Complications
mesh term: Cognitive Dysfunction