<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/NCT03827083</url>
  </required_header>
  <id_info>
    <org_study_id>Fatih Mehmet Kurt</org_study_id>
    <nct_id>NCT03827083</nct_id>
  </id_info>
  <brief_title>Evaluation of Cognitive Functions by Cerebral Pulse Oximetry</brief_title>
  <official_title>Evaluation of Cognitive Functions by Cerebral Pulse Oximetry After General Anesthesia and Spinal Anesthesia in Geriatric Patients With Orthopedic Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tepecik Training and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tepecik Training and Research 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>
      General and Spinal Anesthesia can be used in geriatric patients in orthopedic surgery.&#xD;
      Post-op cognitive dysfunction can be seen in orthopedic surgeries in this group of patients.&#xD;
&#xD;
      In this study, the investigators aimed to compare cognitive functions between spinal and&#xD;
      general anesthesia using cerebral and systemic oxygenation, hemodynamic data and pre-op,&#xD;
      post-op cognitive function tests.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Cerebral Oximeter is a monitoring application based on the measurement of regional oxygen&#xD;
      saturation by transcutaneous route by near infrared spectroscopy technology. With this system&#xD;
      that analyzes the intraparenchymal and microcirculation in the frontal cortex, cerebral&#xD;
      oxygenation changes caused by possible hypoxemia are followed. Unlike pulse oximeter, it&#xD;
      works in non-pulsatile conditions. In other words, continuous, real-time and safe oxygen&#xD;
      saturation is continued to be measured even in the case of cardiopulmonary arrest. It is a&#xD;
      significant advantage of noninvasive measurement according to jugular venous oxygen&#xD;
      saturation measurement. For normal healthy people, the accepted normal range is 58-82%, while&#xD;
      0 to 15% of measurements are important for providing CPR process information.&#xD;
&#xD;
      Oxygen saturation measured by cerebral oximetry is different from that measured by other&#xD;
      oxygen saturation measurement techniques. The main reason for this is the technique itself&#xD;
      and the region where it is used. The radiation emitted by the cerebral oximetry sensor is&#xD;
      aimed at the microvessel structure with venous and arterial mix. Since the contribution of&#xD;
      venous and arterial blood volume in this structure is between 70-75% and 30-25%, different&#xD;
      results are obtained based on only arterial or just venous bed measurements. In this sense,&#xD;
      the measured saturation value is lower than the arterial oxygen and pulse oximetry saturation&#xD;
      values; higher than venous values.&#xD;
&#xD;
      The ratio of oxyhemoglobin to the total hemoglobin below the region under evaluation of the&#xD;
      system is expressed as, value in% System and reflected to the user as Regional Oxygen&#xD;
      Saturation (rSO2). There are publications that can be used not only for cerebral but also for&#xD;
      different tissues (ischemic limb, kidney, etc.).&#xD;
&#xD;
      General and Spinal Anesthesia can be used in geriatric patients in orthopedic surgery.&#xD;
      Post-op cognitive dysfunction may be seen in orthopedic surgery in this patient group. There&#xD;
      are not enough studies showing the correlation of cognitive functions with cerebral pulse&#xD;
      oximetry after general and spinal anesthesia. In this study, the investigators aimed to&#xD;
      compare cognitive functions between spinal and general anesthesia using cerebral and systemic&#xD;
      oxygenation, hemodynamic data and pre-op, post-op cognitive function tests.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 9, 2019</start_date>
  <completion_date type="Actual">December 12, 2019</completion_date>
  <primary_completion_date type="Actual">July 12, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>mini-mental testing</measure>
    <time_frame>preoperative and postoperative 48 hours mini-mental test change</time_frame>
    <description>pre-op and post-op mini-mental testing</description>
  </primary_outcome>
  <primary_outcome>
    <measure>cerebral pulse oxymetry value</measure>
    <time_frame>change in peroperative cerebral pulse oxymetry value</time_frame>
    <description>peroperative cerebral pulse oxymetry value</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>peripheral oxygen saturation</measure>
    <time_frame>1 min before induction, 1 min after induction or sedation, at surgical incision, 15 min of surgery, 30 min of surgery, 45 min of surgery, 60 min of surgery, leaving the operation room, at recovery and post-op 48 hours</time_frame>
    <description>peripheral oxygen saturation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart rate</measure>
    <time_frame>1 min before induction, 1 min after induction or sedation, at surgical incision, 15 min of surgery, 30 min of surgery, 45 min of surgery, 60 min of surgery, leaving the operation room, at recovery and post-op 48 hours</time_frame>
    <description>Heart rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>systolic blood pressure</measure>
    <time_frame>1 min before induction, 1 min after induction or sedation, at surgical incision, 15 min of surgery, 30 min of surgery, 45 min of surgery, 60 min of surgery, leaving the operation room, at recovery and post-op 48 hours</time_frame>
    <description>systolic blood pressure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>diastolic blood pressure</measure>
    <time_frame>1 min before induction, 1 min after induction or sedation, at surgical incision, 15 min of surgery, 30 min of surgery, 45 min of surgery, 60 min of surgery, leaving the operation room, at recovery and post-op 48 hours</time_frame>
    <description>diastolic blood pressure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>hemoglobin value</measure>
    <time_frame>before 24 hours and after 24 hours of surgery</time_frame>
    <description>hemoglobin value</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">40</enrollment>
  <condition>Anesthesia</condition>
  <condition>Cognitive Dysfunction</condition>
  <arm_group>
    <arm_group_label>Spinal anesthesia</arm_group_label>
    <description>Evaluation of cognitive functions of patients under 65 years of age with lower extremity surgery by cerebral pulse oximetry</description>
  </arm_group>
  <arm_group>
    <arm_group_label>General anesthesia</arm_group_label>
    <description>Evaluation of cognitive functions of patients under 65 years of age with lower extremity surgery by cerebral pulse oximetry</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>cerebral pulse oximetry</intervention_name>
    <description>Cognitive Functions by Cerebral Pulse Oximetry After General Anesthesia and Spinal Anesthesia</description>
    <arm_group_label>General anesthesia</arm_group_label>
    <arm_group_label>Spinal anesthesia</arm_group_label>
    <other_name>postoperative cognitive dysfunctions</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with lower extremity surgery, 65 years and older, ASA 1-2, Cognitive functions&#xD;
        sufficient&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ASA 1-2&#xD;
&#xD;
          -  patients with lower extremity surgery&#xD;
&#xD;
          -  Cognitive functions sufficient&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Brain functions affected&#xD;
&#xD;
          -  Peri-operative MAP &lt;60 ones&#xD;
&#xD;
          -  Those with electrolyte dysfunctions&#xD;
&#xD;
          -  Those who need more blood and blood transfusion&#xD;
&#xD;
          -  Patients with ASA 3 and above&#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>
  <overall_official>
    <last_name>Fatih Mehmet Kurt, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Tepecik Train and Research Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>İzmir Tepecik TRH</name>
      <address>
        <city>İzmir</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <reference>
    <citation>Papadopoulos G, Karanikolas M, Liarmakopoulou A, Papathanakos G, Korre M, Beris A. Cerebral oximetry and cognitive dysfunction in elderly patients undergoing surgery for hip fractures: a prospective observational study. Open Orthop J. 2012;6:400-5. doi: 10.2174/1874325001206010400. Epub 2012 Sep 3.</citation>
    <PMID>22962570</PMID>
  </reference>
  <reference>
    <citation>Guo JY, Fang JY, Xu SR, Wei M, Huang WQ. Effects of propofol versus sevoflurane on cerebral oxygenation and cognitive outcome in patients with impaired cerebral oxygenation. Ther Clin Risk Manag. 2016 Jan 18;12:81-5. doi: 10.2147/TCRM.S97066. eCollection 2016.</citation>
    <PMID>26848269</PMID>
  </reference>
  <reference>
    <citation>Kok WF, van Harten AE, Koene BM, Mariani MA, Koerts J, Tucha O, Absalom AR, Scheeren TW. A pilot study of cerebral tissue oxygenation and postoperative cognitive dysfunction among patients undergoing coronary artery bypass grafting randomised to surgery with or without cardiopulmonary bypass*. Anaesthesia. 2014 Jun;69(6):613-22. doi: 10.1111/anae.12634. Epub 2014 Apr 22.</citation>
    <PMID>24750013</PMID>
  </reference>
  <reference>
    <citation>Jo YY, Kim JY, Lee MG, Lee SG, Kwak HJ. Changes in cerebral oxygen saturation and early postoperative cognitive function after laparoscopic gastrectomy: a comparison with conventional open surgery. Korean J Anesthesiol. 2016 Feb;69(1):44-50. doi: 10.4097/kjae.2016.69.1.44. Epub 2016 Jan 28.</citation>
    <PMID>26885301</PMID>
  </reference>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>January 4, 2019</study_first_submitted>
  <study_first_submitted_qc>January 31, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 1, 2019</study_first_posted>
  <last_update_submitted>February 1, 2021</last_update_submitted>
  <last_update_submitted_qc>February 1, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 2, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Tepecik Training and Research Hospital</investigator_affiliation>
    <investigator_full_name>Fatih Mehmet Kurt</investigator_full_name>
    <investigator_title>Principal İnvestigator</investigator_title>
  </responsible_party>
  <keyword>spinal and general anesthesia</keyword>
  <keyword>cerebral pulse oxymetry</keyword>
  <keyword>cognitive dysfunction</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>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/NCT03827083
org study id: Fatih Mehmet Kurt
nct id: NCT03827083
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
General and Spinal Anesthesia can be used in geriatric patients in orthopedic surgery.
      Post-op cognitive dysfunction can be seen in orthopedic surgeries in this group of patients.

      In this study, the investigators aimed to compare cognitive functions between spinal and
      general anesthesia using cerebral and systemic oxygenation, hemodynamic data and pre-op,
      post-op cognitive function tests.
Cerebral Oximeter is a monitoring application based on the measurement of regional oxygen
      saturation by transcutaneous route by near infrared spectroscopy technology. With this system
      that analyzes the intraparenchymal and microcirculation in the frontal cortex, cerebral
      oxygenation changes caused by possible hypoxemia are followed. Unlike pulse oximeter, it
      works in non-pulsatile conditions. In other words, continuous, real-time and safe oxygen
      saturation is continued to be measured even in the case of cardiopulmonary arrest. It is a
      significant advantage of noninvasive measurement according to jugular venous oxygen
      saturation measurement. For normal healthy people, the accepted normal range is 58-82%, while
      0 to 15% of measurements are important for providing CPR process information.

      Oxygen saturation measured by cerebral oximetry is different from that measured by other
      oxygen saturation measurement techniques. The main reason for this is the technique itself
      and the region where it is used. The radiation emitted by the cerebral oximetry sensor is
      aimed at the microvessel structure with venous and arterial mix. Since the contribution of
      venous and arterial blood volume in this structure is between 70-75% and 30-25%, different
      results are obtained based on only arterial or just venous bed measurements. In this sense,
      the measured saturation value is lower than the arterial oxygen and pulse oximetry saturation
      values; higher than venous values.

      The ratio of oxyhemoglobin to the total hemoglobin below the region under evaluation of the
      system is expressed as, value in% System and reflected to the user as Regional Oxygen
      Saturation (rSO2). There are publications that can be used not only for cerebral but also for
      different tissues (ischemic limb, kidney, etc.).

      General and Spinal Anesthesia can be used in geriatric patients in orthopedic surgery.
      Post-op cognitive dysfunction may be seen in orthopedic surgery in this patient group. There
      are not enough studies showing the correlation of cognitive functions with cerebral pulse
      oximetry after general and spinal anesthesia. In this study, the investigators aimed to
      compare cognitive functions between spinal and general anesthesia using cerebral and systemic
      oxygenation, hemodynamic data and pre-op, post-op cognitive function tests.
observational model: Other
time perspective: Prospective
measure: mini-mental testing
time frame: preoperative and postoperative 48 hours mini-mental test change
description: pre-op and post-op mini-mental testing
measure: cerebral pulse oxymetry value
time frame: change in peroperative cerebral pulse oxymetry value
description: peroperative cerebral pulse oxymetry value
measure: peripheral oxygen saturation
time frame: 1 min before induction, 1 min after induction or sedation, at surgical incision, 15 min of surgery, 30 min of surgery, 45 min of surgery, 60 min of surgery, leaving the operation room, at recovery and post-op 48 hours
description: peripheral oxygen saturation
measure: Heart rate
time frame: 1 min before induction, 1 min after induction or sedation, at surgical incision, 15 min of surgery, 30 min of surgery, 45 min of surgery, 60 min of surgery, leaving the operation room, at recovery and post-op 48 hours
description: Heart rate
measure: systolic blood pressure
time frame: 1 min before induction, 1 min after induction or sedation, at surgical incision, 15 min of surgery, 30 min of surgery, 45 min of surgery, 60 min of surgery, leaving the operation room, at recovery and post-op 48 hours
description: systolic blood pressure
measure: diastolic blood pressure
time frame: 1 min before induction, 1 min after induction or sedation, at surgical incision, 15 min of surgery, 30 min of surgery, 45 min of surgery, 60 min of surgery, leaving the operation room, at recovery and post-op 48 hours
description: diastolic blood pressure
measure: hemoglobin value
time frame: before 24 hours and after 24 hours of surgery
description: hemoglobin value
arm group label: Spinal anesthesia
description: Evaluation of cognitive functions of patients under 65 years of age with lower extremity surgery by cerebral pulse oximetry
arm group label: General anesthesia
description: Evaluation of cognitive functions of patients under 65 years of age with lower extremity surgery by cerebral pulse oximetry
intervention type: Other
intervention name: cerebral pulse oximetry
description: Cognitive Functions by Cerebral Pulse Oximetry After General Anesthesia and Spinal Anesthesia
arm group label: General anesthesia
arm group label: Spinal anesthesia
other name: postoperative cognitive dysfunctions
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Fatih Mehmet Kurt, MD
role: Principal Investigator
affiliation: Tepecik Train and Research Hospital
facility: 
country: Turkey
citation: Papadopoulos G, Karanikolas M, Liarmakopoulou A, Papathanakos G, Korre M, Beris A. Cerebral oximetry and cognitive dysfunction in elderly patients undergoing surgery for hip fractures: a prospective observational study. Open Orthop J. 2012;6:400-5. doi: 10.2174/1874325001206010400. Epub 2012 Sep 3.
PMID: 22962570
citation: Guo JY, Fang JY, Xu SR, Wei M, Huang WQ. Effects of propofol versus sevoflurane on cerebral oxygenation and cognitive outcome in patients with impaired cerebral oxygenation. Ther Clin Risk Manag. 2016 Jan 18;12:81-5. doi: 10.2147/TCRM.S97066. eCollection 2016.
PMID: 26848269
citation: Kok WF, van Harten AE, Koene BM, Mariani MA, Koerts J, Tucha O, Absalom AR, Scheeren TW. A pilot study of cerebral tissue oxygenation and postoperative cognitive dysfunction among patients undergoing coronary artery bypass grafting randomised to surgery with or without cardiopulmonary bypass*. Anaesthesia. 2014 Jun;69(6):613-22. doi: 10.1111/anae.12634. Epub 2014 Apr 22.
PMID: 24750013
citation: Jo YY, Kim JY, Lee MG, Lee SG, Kwak HJ. Changes in cerebral oxygen saturation and early postoperative cognitive function after laparoscopic gastrectomy: a comparison with conventional open surgery. Korean J Anesthesiol. 2016 Feb;69(1):44-50. doi: 10.4097/kjae.2016.69.1.44. Epub 2016 Jan 28.
PMID: 26885301
responsible party type: Principal Investigator
investigator affiliation: Tepecik Training and Research Hospital
investigator full name: Fatih Mehmet Kurt
investigator title: Principal İnvestigator
mesh term: Cognitive Dysfunction
sharing ipd: No