<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/NCT03775343</url>
  </required_header>
  <id_info>
    <org_study_id>1907/2017</org_study_id>
    <nct_id>NCT03775343</nct_id>
  </id_info>
  <brief_title>Early Postoperative Cognitive Impairment in Elderly Patients Following Ocular Surgery</brief_title>
  <official_title>Early Postoperative Cognitive Impairment in Elderly Patients Following Ocular Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Vienna</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University of Vienna</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>
      This project will investigate changes in cognitive function in the early postoperative phase&#xD;
      (&lt;24 hours) after minor surgery in patients of older age (≥65 years).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Primary aim of this study is to evaluate changes in cognitive function in the early&#xD;
      postoperative phase after minor surgery in patients of older age (≥65 years).&#xD;
&#xD;
      Background: Postoperative cognitive dysfunction can be a serious complication after surgery&#xD;
      and is associated with higher mortality.Several studies have demonstrated that major surgery&#xD;
      and patients of older age are risk factors for the incidence of cognitive decline in the&#xD;
      postoperative phase. Only a few studies investigated the early postoperative changes in&#xD;
      cognitive function (&lt; 24 hours) after minor, day case surgeries in older patients (≥65&#xD;
      years), demonstrating a higher incidence than observed ≥1 week after surgery.&#xD;
&#xD;
      Aim of the project: This study aimed to investigate changes in cognitive function after minor&#xD;
      surgery in an elderly patient cohort.&#xD;
&#xD;
      It is the effort to plan perioperative care that can reduce the incidence of postoperative&#xD;
      cognitive dysfunction in elderly.&#xD;
&#xD;
      Hypothesis: The present study support the hypothesis that changes in cognitive function after&#xD;
      ocular surgery will be greater in the general anesthesia group compared to the sedoanalgesia&#xD;
      group.&#xD;
&#xD;
      Methods:&#xD;
&#xD;
      The study will be conducted as a single center, prospective, observational controlled trial&#xD;
      at the Medical University of Vienna, Austria.&#xD;
&#xD;
      This prospective and observational study involves consecutive elderly patients (≥65 years)&#xD;
      undergoing a minor surgery using general anesthesia or local anesthesia with sedoanalgesia.&#xD;
      Fifty patients, 65 years and older, scheduled for elective minor ocular surgery and 25&#xD;
      participants as control group without surgical intervention will be recruited.&#xD;
&#xD;
      Enrollees will be divided in 3 groups:&#xD;
&#xD;
      25 patients general anaesthesia (GA), 25 patients sedoanalgesia combined with local&#xD;
      anaesthesia (SA) and 25 participants as control group(CO) without surgical intervention.&#xD;
&#xD;
      Anesthesia will be induced in a standardized fashion in both groups (GA,SA). At baseline the&#xD;
      performance on neurocognitive testing using the Mini Mental State Examination (MMSE) hast to&#xD;
      be ≥24, otherwise participants will be excluded.&#xD;
&#xD;
      The design utilizes prospective serial assessments of cognitive status. The participants will&#xD;
      be evaluated preoperatively and postoperatively over 3 time-points (preoperatively, 6 and 24&#xD;
      hours after surgery) using the Neurocognitive Test Battery Vienna (NTBV) for cognitive&#xD;
      assessment.&#xD;
&#xD;
      At the same time points blood tests for plasma levels of S 100-B, IL-6, CRP, vitamin B 12,&#xD;
      vitamin D, homocysteine and folic acid will be taken.&#xD;
&#xD;
      This project will investigate the correlation between perioperative changes in these serum&#xD;
      parameters with neurocognitive outcome in the elderly after minor surgery to explore whether&#xD;
      the concentrations of these parameters can be used as predictors of postoperative cognitive&#xD;
      dysfunction and to provide reference for postoperative cognitive dysfunction prevention,&#xD;
      early detection and timely diagnosis and treatment.&#xD;
&#xD;
      Further purpose of this study is to investigate if there is an association between changes in&#xD;
      intraoperative cerebral oxygenation, changes in perioperative blood pressure, depth of&#xD;
      anaesthesia and the presence of cognitive deterioration after surgery.&#xD;
&#xD;
      It is the effort to plan perioperative care that can reduce the incidence of postoperative&#xD;
      changes in cognitive function.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 6, 2018</start_date>
  <completion_date type="Actual">August 30, 2023</completion_date>
  <primary_completion_date type="Actual">August 28, 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Neuropsychological Test Battery Vienna (NTBV)</measure>
    <time_frame>before surgery (baseline) and 24 hours after surgery</time_frame>
    <description>The Neuropsychological Test Battery Vienna (NTBV) ist a cognitive test to assess a broad range of cognitive abilities.(Lehrner J., 2007) It was created to detect cognitive impairment in Alzheimer's Disease (Lehrner J., 2007). The investigators will investigate changes in NTBV between baseline compared to 24 hour after minor surgery using regression based z-score analyses (-1,5 - + 1,5 standard deviation(SD) ; &gt; -1,5 SD indicating a larger decline in cognitive function).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Neuropsychological Test Battery Vienna (NTBV)</measure>
    <time_frame>before surgery(baseline) and 6 hours after surgery</time_frame>
    <description>The Neuropsychological Test Battery Vienna (NTBV) ist a cognitive test. (Lehrner J., 2007)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Blood sampling- S100b levels</measure>
    <time_frame>before surgery, at the end point of surgery, 6 and 24 hours after surgery</time_frame>
    <description>Blood sampling will be taken at all patients scheduled for elective ocular surgery. Levels of S100-B protein (µg/L) will be obtained from venous blood samples collected before surgery, at the end point of surgery, 6 and 24 hours after surgery.</description>
  </other_outcome>
  <other_outcome>
    <measure>Blood sampling- IL-6 levels</measure>
    <time_frame>before surgery, at the end point of surgery, 6 and 24 hours after surgery</time_frame>
    <description>Blood sampling will be taken at all patients scheduled for elective ocular surgery. Serum levels of interleukin-6 type cytokines (IL-6 (pg/mL)) will be obtained from venous blood samples collected before surgery, at the end point of surgery, 6 and 24 hours after surgery.</description>
  </other_outcome>
  <other_outcome>
    <measure>Blood sampling- CRP levels</measure>
    <time_frame>before surgery, at the end point of surgery, 6 and 24 hours after surgery</time_frame>
    <description>Blood sampling will be taken at all patients scheduled for elective ocular surgery. Levels of C-Reactive Protein (CRP) (mg/L)will be obtained from venous blood samples collected before surgery, at the end point of surgery, 6 and 24 hours after surgery.</description>
  </other_outcome>
  <other_outcome>
    <measure>Blood sampling- vitamin B12 levels</measure>
    <time_frame>before surgery, at the end point of surgery, 6 and 24 hours after surgery</time_frame>
    <description>Blood sampling will be taken at all patients scheduled for elective ocular surgery. Levels of vitamin B12 (pg/mL) will be obtained from venous blood samples collected before surgery, at the end point of surgery, 6 and 24 hours after surgery.</description>
  </other_outcome>
  <other_outcome>
    <measure>Blood sampling- vitamin D levels</measure>
    <time_frame>before surgery, at the end point of surgery, 6 and 24 hours after surgery</time_frame>
    <description>Blood sampling will be taken at all patients scheduled for elective ocular surgery. Levels of vitamin D (ng/ml) will be obtained from venous blood samples collected before surgery, at the end point of surgery, 6 and 24 hours after surgery.</description>
  </other_outcome>
  <other_outcome>
    <measure>Blood sampling- homocysteine levels</measure>
    <time_frame>before surgery, at the end point of surgery, 6 and 24 hours after surgery</time_frame>
    <description>Blood sampling will be taken at all patients scheduled for elective ocular surgery. Levels of homocysteine (mcmol/L)will be obtained from venous blood samples collected before surgery, at the end point of surgery, 6 and 24 hours after surgery.</description>
  </other_outcome>
  <other_outcome>
    <measure>Blood sampling- folic acid levels</measure>
    <time_frame>before surgery, at the end point of surgery, 6 and 24 hours after surgery</time_frame>
    <description>Blood sampling will be taken at all patients scheduled for elective ocular surgery. Levels of folic acid (µg/L) will be obtained from venous blood samples collected before surgery, at the end point of surgery, 6 and 24 hours after surgery.</description>
  </other_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">75</enrollment>
  <condition>Cognitive Decline</condition>
  <arm_group>
    <arm_group_label>General Anesthesia</arm_group_label>
    <description>General anesthesia:&#xD;
25 patients older than 65 years, undergoing elective eye surgery under general anesthesia.&#xD;
Intervention: neurocognitive testing (Neurocognitive Test Battery) preoperative, 6 and 24 hours postoperative.&#xD;
Blood sampling before surgery (baseline), immediately postoperative, 6 and 24 hours after surgery.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Local anesthesia with sedoanalgesia</arm_group_label>
    <description>25 patients older than 65 years, undergoing elective eye surgery under local anesthesia in combination with sedoanalgesia.&#xD;
Intervention: neurocognitive testing (Neurocognitive Test Battery) preoperative, 6 and 24 hours postoperative Blood sampling before surgery (baseline), immediately postoperative, 6 and 24 hours after surgery.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <description>25 patients, not undergoing any operative intervention. To determine a normal reference value of cognitive functions, a group of 25 individuals without an operative intervention will be recruited as a control group.&#xD;
Intervention: neurocognitive testing (Neurocognitive Test Battery) at 3 determined time points (0, 6 and 24 hours)</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Neurocognitive Test Battery</intervention_name>
    <description>neurocognitive testing: preoperative(baseline), 6 and 24 hours postoperative.</description>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_label>General Anesthesia</arm_group_label>
    <arm_group_label>Local anesthesia with sedoanalgesia</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Blood sampling</intervention_name>
    <description>Blood sampling before surgery (baseline), immediately postoperative, 6 and 24 hours after surgery, investigating plasma levels of S 100-B, CRP, vitamines, homocysteine and folic acid</description>
    <arm_group_label>General Anesthesia</arm_group_label>
    <arm_group_label>Local anesthesia with sedoanalgesia</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      samples of blood taken before and after intervention, investigating biomarkers for cognitive&#xD;
      impairment&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        50 patients 65 years and older without any significant mental (MMSE ≥24) or&#xD;
        neuropsychiatric disorders scheduled for elective ocular surgery requiring general&#xD;
        anaesthesia or sedoanalgesia will be undergoing serial cognitive assessements pre- and&#xD;
        postoperatively over 3 time-points.&#xD;
&#xD;
        To determine a normal reference value of cognitive functions, a group of 25 participants in&#xD;
        the same age (≥65 years)and without surgical intervention will be recruited as a control&#xD;
        group and undergo serial cognitive assessements over 3 time-points.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients age 65 and older&#xD;
&#xD;
          2. scheduled to undergo elective ocular surgery&#xD;
&#xD;
          3. American Society of Anesthesiologists class I, II or III&#xD;
&#xD;
          4. MMSE score ≥ 24&#xD;
&#xD;
          5. The people signed informed consent.&#xD;
&#xD;
          6. Expected surgical duration &lt;90 minutes&#xD;
&#xD;
          7. Able to follow study instructions.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients age &lt; 65 years&#xD;
&#xD;
          2. Emergent nature of the ocular surgery&#xD;
&#xD;
          3. American Society of Anesthesiologists class IV&#xD;
&#xD;
          4. MMSE score &lt; 24&#xD;
&#xD;
          5. unsigned informed consent&#xD;
&#xD;
          6. Expected surgical duration &gt;90 minutes&#xD;
&#xD;
          7. Not able to follow study instructions.&#xD;
&#xD;
          8. History of psychiatric or neurologic disorders (epilepsy, trauma, stroke,depressive&#xD;
             disorders, hemorrhage, transient ischemic attack&#xD;
&#xD;
          9. Drug or substance abuse history&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Medical University Vienna</name>
      <address>
        <city>Vienna</city>
        <zip>1090</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <reference>
    <citation>Lehrner, J.; Maly, J.; Gleiß, A.; Auff, E. &amp; Dal-Bianco, P., Demenzdiagnostik mit Hilfe der Vienna Neuropsychologischen Testbatterie (VNTB): Standardisierung, Normierung und Validierung, Psychol. Österreich, 4, 358-365, 2007.</citation>
  </reference>
  <reference>
    <citation>Foki T, Hitzl D, Pirker W, Novak K, Pusswald G, Auff E, Lehrner J. Erratum to: Assessment of individual cognitive changes after deep brain stimulation surgery in Parkinson's disease using the Neuropsychological Test Battery Vienna short version. Wien Klin Wochenschr. 2017 Aug;129(15-16):585-587. doi: 10.1007/s00508-017-1210-2. No abstract available.</citation>
    <PMID>28741045</PMID>
  </reference>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>October 26, 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>August 29, 2023</last_update_submitted>
  <last_update_submitted_qc>August 29, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 30, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical University of Vienna</investigator_affiliation>
    <investigator_full_name>Marita Windpassinger M.D.</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Anesthesia</keyword>
  <keyword>Postoperative cognitive decline</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cognitive Dysfunction</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>not yet decided</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/NCT03775343
org study id: 1907/2017
nct id: NCT03775343
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This project will investigate changes in cognitive function in the early postoperative phase
      (<24 hours) after minor surgery in patients of older age (≥65 years).
Primary aim of this study is to evaluate changes in cognitive function in the early
      postoperative phase after minor surgery in patients of older age (≥65 years).

      Background: Postoperative cognitive dysfunction can be a serious complication after surgery
      and is associated with higher mortality.Several studies have demonstrated that major surgery
      and patients of older age are risk factors for the incidence of cognitive decline in the
      postoperative phase. Only a few studies investigated the early postoperative changes in
      cognitive function (< 24 hours) after minor, day case surgeries in older patients (≥65
      years), demonstrating a higher incidence than observed ≥1 week after surgery.

      Aim of the project: This study aimed to investigate changes in cognitive function after minor
      surgery in an elderly patient cohort.

      It is the effort to plan perioperative care that can reduce the incidence of postoperative
      cognitive dysfunction in elderly.

      Hypothesis: The present study support the hypothesis that changes in cognitive function after
      ocular surgery will be greater in the general anesthesia group compared to the sedoanalgesia
      group.

      Methods:

      The study will be conducted as a single center, prospective, observational controlled trial
      at the Medical University of Vienna, Austria.

      This prospective and observational study involves consecutive elderly patients (≥65 years)
      undergoing a minor surgery using general anesthesia or local anesthesia with sedoanalgesia.
      Fifty patients, 65 years and older, scheduled for elective minor ocular surgery and 25
      participants as control group without surgical intervention will be recruited.

      Enrollees will be divided in 3 groups:

      25 patients general anaesthesia (GA), 25 patients sedoanalgesia combined with local
      anaesthesia (SA) and 25 participants as control group(CO) without surgical intervention.

      Anesthesia will be induced in a standardized fashion in both groups (GA,SA). At baseline the
      performance on neurocognitive testing using the Mini Mental State Examination (MMSE) hast to
      be ≥24, otherwise participants will be excluded.

      The design utilizes prospective serial assessments of cognitive status. The participants will
      be evaluated preoperatively and postoperatively over 3 time-points (preoperatively, 6 and 24
      hours after surgery) using the Neurocognitive Test Battery Vienna (NTBV) for cognitive
      assessment.

      At the same time points blood tests for plasma levels of S 100-B, IL-6, CRP, vitamin B 12,
      vitamin D, homocysteine and folic acid will be taken.

      This project will investigate the correlation between perioperative changes in these serum
      parameters with neurocognitive outcome in the elderly after minor surgery to explore whether
      the concentrations of these parameters can be used as predictors of postoperative cognitive
      dysfunction and to provide reference for postoperative cognitive dysfunction prevention,
      early detection and timely diagnosis and treatment.

      Further purpose of this study is to investigate if there is an association between changes in
      intraoperative cerebral oxygenation, changes in perioperative blood pressure, depth of
      anaesthesia and the presence of cognitive deterioration after surgery.

      It is the effort to plan perioperative care that can reduce the incidence of postoperative
      changes in cognitive function.
observational model: Case-Control
time perspective: Prospective
measure: Neuropsychological Test Battery Vienna (NTBV)
time frame: before surgery (baseline) and 24 hours after surgery
description: The Neuropsychological Test Battery Vienna (NTBV) ist a cognitive test to assess a broad range of cognitive abilities.(Lehrner J., 2007) It was created to detect cognitive impairment in Alzheimer's Disease (Lehrner J., 2007). The investigators will investigate changes in NTBV between baseline compared to 24 hour after minor surgery using regression based z-score analyses (-1,5 - + 1,5 standard deviation(SD) ; > -1,5 SD indicating a larger decline in cognitive function).
measure: Neuropsychological Test Battery Vienna (NTBV)
time frame: before surgery(baseline) and 6 hours after surgery
description: The Neuropsychological Test Battery Vienna (NTBV) ist a cognitive test. (Lehrner J., 2007)
measure: Blood sampling- S100b levels
time frame: before surgery, at the end point of surgery, 6 and 24 hours after surgery
description: Blood sampling will be taken at all patients scheduled for elective ocular surgery. Levels of S100-B protein (µg/L) will be obtained from venous blood samples collected before surgery, at the end point of surgery, 6 and 24 hours after surgery.
measure: Blood sampling- IL-6 levels
time frame: before surgery, at the end point of surgery, 6 and 24 hours after surgery
description: Blood sampling will be taken at all patients scheduled for elective ocular surgery. Serum levels of interleukin-6 type cytokines (IL-6 (pg/mL)) will be obtained from venous blood samples collected before surgery, at the end point of surgery, 6 and 24 hours after surgery.
measure: Blood sampling- CRP levels
time frame: before surgery, at the end point of surgery, 6 and 24 hours after surgery
description: Blood sampling will be taken at all patients scheduled for elective ocular surgery. Levels of C-Reactive Protein (CRP) (mg/L)will be obtained from venous blood samples collected before surgery, at the end point of surgery, 6 and 24 hours after surgery.
measure: Blood sampling- vitamin B12 levels
time frame: before surgery, at the end point of surgery, 6 and 24 hours after surgery
description: Blood sampling will be taken at all patients scheduled for elective ocular surgery. Levels of vitamin B12 (pg/mL) will be obtained from venous blood samples collected before surgery, at the end point of surgery, 6 and 24 hours after surgery.
measure: Blood sampling- vitamin D levels
time frame: before surgery, at the end point of surgery, 6 and 24 hours after surgery
description: Blood sampling will be taken at all patients scheduled for elective ocular surgery. Levels of vitamin D (ng/ml) will be obtained from venous blood samples collected before surgery, at the end point of surgery, 6 and 24 hours after surgery.
measure: Blood sampling- homocysteine levels
time frame: before surgery, at the end point of surgery, 6 and 24 hours after surgery
description: Blood sampling will be taken at all patients scheduled for elective ocular surgery. Levels of homocysteine (mcmol/L)will be obtained from venous blood samples collected before surgery, at the end point of surgery, 6 and 24 hours after surgery.
measure: Blood sampling- folic acid levels
time frame: before surgery, at the end point of surgery, 6 and 24 hours after surgery
description: Blood sampling will be taken at all patients scheduled for elective ocular surgery. Levels of folic acid (µg/L) will be obtained from venous blood samples collected before surgery, at the end point of surgery, 6 and 24 hours after surgery.
arm group label: General Anesthesia
description: General anesthesia:
25 patients older than 65 years, undergoing elective eye surgery under general anesthesia.
Intervention: neurocognitive testing (Neurocognitive Test Battery) preoperative, 6 and 24 hours postoperative.
Blood sampling before surgery (baseline), immediately postoperative, 6 and 24 hours after surgery.
arm group label: Local anesthesia with sedoanalgesia
description: 25 patients older than 65 years, undergoing elective eye surgery under local anesthesia in combination with sedoanalgesia.
Intervention: neurocognitive testing (Neurocognitive Test Battery) preoperative, 6 and 24 hours postoperative Blood sampling before surgery (baseline), immediately postoperative, 6 and 24 hours after surgery.
arm group label: Control Group
description: 25 patients, not undergoing any operative intervention. To determine a normal reference value of cognitive functions, a group of 25 individuals without an operative intervention will be recruited as a control group.
Intervention: neurocognitive testing (Neurocognitive Test Battery) at 3 determined time points (0, 6 and 24 hours)
intervention type: Diagnostic Test
intervention name: Neurocognitive Test Battery
description: neurocognitive testing: preoperative(baseline), 6 and 24 hours postoperative.
arm group label: Control Group
arm group label: General Anesthesia
arm group label: Local anesthesia with sedoanalgesia
intervention type: Diagnostic Test
intervention name: Blood sampling
description: Blood sampling before surgery (baseline), immediately postoperative, 6 and 24 hours after surgery, investigating plasma levels of S 100-B, CRP, vitamines, homocysteine and folic acid
arm group label: General Anesthesia
arm group label: Local anesthesia with sedoanalgesia
samples of blood taken before and after intervention, investigating biomarkers for cognitive
      impairment
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Austria
citation: Lehrner, J.; Maly, J.; Gleiß, A.; Auff, E. & Dal-Bianco, P., Demenzdiagnostik mit Hilfe der Vienna Neuropsychologischen Testbatterie (VNTB): Standardisierung, Normierung und Validierung, Psychol. Österreich, 4, 358-365, 2007.
citation: Foki T, Hitzl D, Pirker W, Novak K, Pusswald G, Auff E, Lehrner J. Erratum to: Assessment of individual cognitive changes after deep brain stimulation surgery in Parkinson's disease using the Neuropsychological Test Battery Vienna short version. Wien Klin Wochenschr. 2017 Aug;129(15-16):585-587. doi: 10.1007/s00508-017-1210-2. No abstract available.
PMID: 28741045
responsible party type: Principal Investigator
investigator affiliation: Medical University of Vienna
investigator full name: Marita Windpassinger M.D.
investigator title: Principal Investigator
mesh term: Cognitive Dysfunction
sharing ipd: Undecided
ipd description: not yet decided