<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/NCT03018522</url>
  </required_header>
  <id_info>
    <org_study_id>AntalyaTRH14</org_study_id>
    <nct_id>NCT03018522</nct_id>
  </id_info>
  <brief_title>S100B Protein and Postoperative Cognitive Dysfunction</brief_title>
  <official_title>S100B Protein as Predictor of Cognitive Dysfunction After Robot-assisted Radical Prostatectomy: A Prospective Observational Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Antalya Training and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Antalya Training and Research Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Primary aim of this study is to evaluate the association between postoperative cognitive&#xD;
      dysfunction and increased serum levels of S100B protein after robot-assisted laparoscopic&#xD;
      radical prostatectomy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The neurocognitive assessment protocol will design to evaluate general cognitive function and&#xD;
      identify patients with cognitive dysfunction. Neuropsychological tests of all patients will&#xD;
      conduct on the one day prior to surgery, the seventh day after surgery, and the 3rd month&#xD;
      after surgery, respectively. According to a consensus statement, cognitive function will&#xD;
      assess using a battery of seven neuropsychological tests: Rey Auditory Verbal Learning Test&#xD;
      (delayed recall), Trail Making Test (Parts A and B), Digit Span Test (forward and backward),&#xD;
      and Grooved Pegboard Test (dominant and non-dominant hands). To determine a normal reference&#xD;
      value of cognitive functions, a group of 20 healthy individuals appropriately selected with&#xD;
      respect to sex, age and education level without any significant mental or somatic disorders&#xD;
      and without operation were recruited as a control group. To determine the cognitive&#xD;
      dysfunction, baseline score or time measurement were subtracted from test score and the&#xD;
      difference was divided by the standard deviation of the score in the control group. The&#xD;
      result was called the Z score. Z score was calculated for each test and, POCD was defined as&#xD;
      a Z score greater than 1.96 in at least two of the seven tests, and/or a combined Z score&#xD;
      greater than 1.96.&#xD;
&#xD;
      Serum levels of S100B protein will obtain from venous blood samples collected before surgery,&#xD;
      after anesthesia induction, at 30 min and 24 h after surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 14, 2017</start_date>
  <completion_date type="Actual">February 14, 2018</completion_date>
  <primary_completion_date type="Actual">November 24, 2017</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>Score in Neuropsychological Tests</measure>
    <time_frame>Change from neuropsychological test scores at 3 months.</time_frame>
    <description>This assessment will be applied before surgery, and 7 days and 3 months after surgery.</description>
  </primary_outcome>
  <enrollment type="Actual">89</enrollment>
  <condition>Postoperative Cognitive Dysfunction</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Postoperative cognitive dysfunction</intervention_name>
    <description>Neuropsychological tests of all patients will conduct on the one day prior to surgery, the 7th day after surgery, and the 3rd month after surgery</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adults between 50 and 90 years of age with robot assisted laparoscopic radical&#xD;
        prostatectomy , were selected in the study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  over 50 years old&#xD;
&#xD;
          -  scheduled for robotic-assisted laparoscopic radical prostatectomy&#xD;
&#xD;
          -  the body mass index ranged from 18 kg/m2 to 25 kg/m2&#xD;
&#xD;
          -  American Society of Anesthesiologists class I, II or III&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with previous neurological deficit (symptomatic stroke, hemorrhage, transient&#xD;
             ischemic attack)&#xD;
&#xD;
          -  other neurologic disorders (epilepsy, trauma, intra- or extracranial malignancy)&#xD;
&#xD;
          -  psychiatric diseases (schizophrenia, or depressive disorder)&#xD;
&#xD;
          -  alcoholism or any other drug dependence&#xD;
&#xD;
          -  serious hearing or visual impairment&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nilgun Kavrut Ozturk, M.D.</last_name>
    <role>Study Director</role>
    <affiliation>Antalya Training and Research Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Antalya Training and Research Hospital, Department of Anesthesiology and Reanimation</name>
      <address>
        <city>Antalya</city>
        <zip>07100</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <reference>
    <citation>Silva FP, Schmidt AP, Valentin LS, Pinto KO, Zeferino SP, Oses JP, Wiener CD, Otsuki DA, Tort AB, Portela LV, Souza DO, Auler JO Jr, Carmona MJ. S100B protein and neuron-specific enolase as predictors of cognitive dysfunction after coronary artery bypass graft surgery: A prospective observational study. Eur J Anaesthesiol. 2016 Sep;33(9):681-9. doi: 10.1097/EJA.0000000000000450.</citation>
    <PMID>27433840</PMID>
  </reference>
  <reference>
    <citation>Tomaszewski D. Biomarkers of Brain Damage and Postoperative Cognitive Disorders in Orthopedic Patients: An Update. Biomed Res Int. 2015;2015:402959. doi: 10.1155/2015/402959. Epub 2015 Aug 31.</citation>
    <PMID>26417595</PMID>
  </reference>
  <reference>
    <citation>Chen K, Wei P, Zheng Q, Zhou J, Li J. Neuroprotective effects of intravenous lidocaine on early postoperative cognitive dysfunction in elderly patients following spine surgery. Med Sci Monit. 2015 May 15;21:1402-7. doi: 10.12659/MSM.894384.</citation>
    <PMID>25975969</PMID>
  </reference>
  <reference>
    <citation>van Munster BC, Korevaar JC, Korse CM, Bonfrer JM, Zwinderman AH, de Rooij SE. Serum S100B in elderly patients with and without delirium. Int J Geriatr Psychiatry. 2010 Mar;25(3):234-9. doi: 10.1002/gps.2326.</citation>
    <PMID>19575407</PMID>
  </reference>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>January 9, 2017</study_first_submitted>
  <study_first_submitted_qc>January 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 12, 2017</study_first_posted>
  <last_update_submitted>May 30, 2018</last_update_submitted>
  <last_update_submitted_qc>May 30, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 31, 2018</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>Postoperative Cognitive Complications</mesh_term>
    <mesh_term>Cognitive Dysfunction</mesh_term>
  </condition_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/NCT03018522
org study id: AntalyaTRH14
nct id: NCT03018522
lead sponsor: 
has dmc: No
Primary aim of this study is to evaluate the association between postoperative cognitive
      dysfunction and increased serum levels of S100B protein after robot-assisted laparoscopic
      radical prostatectomy.
The neurocognitive assessment protocol will design to evaluate general cognitive function and
      identify patients with cognitive dysfunction. Neuropsychological tests of all patients will
      conduct on the one day prior to surgery, the seventh day after surgery, and the 3rd month
      after surgery, respectively. According to a consensus statement, cognitive function will
      assess using a battery of seven neuropsychological tests: Rey Auditory Verbal Learning Test
      (delayed recall), Trail Making Test (Parts A and B), Digit Span Test (forward and backward),
      and Grooved Pegboard Test (dominant and non-dominant hands). To determine a normal reference
      value of cognitive functions, a group of 20 healthy individuals appropriately selected with
      respect to sex, age and education level without any significant mental or somatic disorders
      and without operation were recruited as a control group. To determine the cognitive
      dysfunction, baseline score or time measurement were subtracted from test score and the
      difference was divided by the standard deviation of the score in the control group. The
      result was called the Z score. Z score was calculated for each test and, POCD was defined as
      a Z score greater than 1.96 in at least two of the seven tests, and/or a combined Z score
      greater than 1.96.

      Serum levels of S100B protein will obtain from venous blood samples collected before surgery,
      after anesthesia induction, at 30 min and 24 h after surgery.
observational model: Cohort
time perspective: Prospective
measure: Score in Neuropsychological Tests
time frame: Change from neuropsychological test scores at 3 months.
description: This assessment will be applied before surgery, and 7 days and 3 months after surgery.
intervention type: Other
intervention name: Postoperative cognitive dysfunction
description: Neuropsychological tests of all patients will conduct on the one day prior to surgery, the 7th day after surgery, and the 3rd month after surgery
study pop: 
sampling method: Probability Sample
criteria: 
gender: Male
minimum age: 50 Years
maximum age: 90 Years
healthy volunteers: No
last name: Nilgun Kavrut Ozturk, M.D.
role: Study Director
affiliation: Antalya Training and Research Hospital
facility: 
country: Turkey
citation: Silva FP, Schmidt AP, Valentin LS, Pinto KO, Zeferino SP, Oses JP, Wiener CD, Otsuki DA, Tort AB, Portela LV, Souza DO, Auler JO Jr, Carmona MJ. S100B protein and neuron-specific enolase as predictors of cognitive dysfunction after coronary artery bypass graft surgery: A prospective observational study. Eur J Anaesthesiol. 2016 Sep;33(9):681-9. doi: 10.1097/EJA.0000000000000450.
PMID: 27433840
citation: Tomaszewski D. Biomarkers of Brain Damage and Postoperative Cognitive Disorders in Orthopedic Patients: An Update. Biomed Res Int. 2015;2015:402959. doi: 10.1155/2015/402959. Epub 2015 Aug 31.
PMID: 26417595
citation: Chen K, Wei P, Zheng Q, Zhou J, Li J. Neuroprotective effects of intravenous lidocaine on early postoperative cognitive dysfunction in elderly patients following spine surgery. Med Sci Monit. 2015 May 15;21:1402-7. doi: 10.12659/MSM.894384.
PMID: 25975969
citation: van Munster BC, Korevaar JC, Korse CM, Bonfrer JM, Zwinderman AH, de Rooij SE. Serum S100B in elderly patients with and without delirium. Int J Geriatr Psychiatry. 2010 Mar;25(3):234-9. doi: 10.1002/gps.2326.
PMID: 19575407
responsible party type: Sponsor
mesh term: Postoperative Cognitive Complications
mesh term: Cognitive Dysfunction
sharing ipd: No