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/NCT06036498</url>
    </required_header>
    <id_info>
      <org_study_id>Bursa Uludag Universitesi</org_study_id>
      <nct_id>NCT06036498</nct_id>
    </id_info>
    <brief_title>Evaluation of Cerebral Blood Flow and Cerebral Oxygenation With Transcranial Doppler and NIRS in Laparoscopic Cholecystectomy Cases</brief_title>
    <acronym>NIRS L/C</acronym>
    <official_title>Evaluation of Cerebral Blood Flow and Cerebral Oxygenation With Transcranial Doppler and NIRS in Laparoscopic Cholecystectomy Cases</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Uludag University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Uludag University</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>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this clinical trial is to test intracranial blood flow and cerebral oxygenisation&#xD;
        changes in patients who have pneumoperitoneum in laparoscopic cholecystectomy procedure.&#xD;
  &#xD;
        The main questions aim to answer are:&#xD;
  &#xD;
          -  How does pneumoperitoneum in laparoscopic cholecystectomy procedure changes blod flow in&#xD;
             patients?&#xD;
  &#xD;
          -  Are there any differences between Near-Red spectroscopy and transcranial doppler&#xD;
             ultrasonography assesment?&#xD;
  &#xD;
        Participants will be diagnosed with using NIRS probes and Doppler ultrasonography probes if&#xD;
        any changes in surgical procedure.&#xD;
  &#xD;
        Researchers will compare NIRS and TCD detection outcomes to see if there is any differences.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Laparoscopic cholecystectomy is the gold standard treatment method for benign gallbladder&#xD;
        stones. The required pneumoperitoneum for the operation leads to hemodynamic and metabolic&#xD;
        changes in patients. Prolonged complicated laparoscopic surgeries also pose an additional&#xD;
        risk factor for neurological complications.&#xD;
  &#xD;
        Cerebral circulation occurs within a closed environment enclosed by the skull. This&#xD;
        environment includes brain tissue, blood volume, and cerebrospinal fluid. Cerebral blood&#xD;
        pressure arises from the difference between arterial blood pressure and intracranial&#xD;
        pressure. Due to carbondioxide insufflation in laparoscopic surgery, caused by&#xD;
        pneumoperitoneum creation, intra-abdominal carbondioxide is rapidly absorbed through the&#xD;
        peritoneal membrane and enters the bloodstream.&#xD;
  &#xD;
        Carbonic acid formed by the carbonic anhydrase enzyme in the plasma leads to respiratory&#xD;
        acidosis. The resulting respiratory acidosis triggers peripheral and central vasodilation to&#xD;
        ensure oxygenation and gas exchange, causing a rightward shift in the hemoglobin curve.&#xD;
        Hypercarbia's impact on cells and the effect of cellular acidosis lead to local tissue edema.&#xD;
        All of these factors contribute to changes in transcranial pressure. An increase in&#xD;
        intracranial pressure can result in impaired cerebral perfusion.&#xD;
  &#xD;
        Transcranial Doppler (TCD) is a reliable tool for imaging intracranial pressure due to its&#xD;
        affordability, non-invasiveness, repeatability at the bedside, and real-time data provision&#xD;
        during acute situations. Transcranial Doppler ultrasonography (TCD) can better display flow&#xD;
        velocity waveforms, flow direction, intraparenchymal flow velocity, and density compared to&#xD;
        other diagnostic tests. Changes in waveforms detected by TCD allow tracking changes in&#xD;
        intracranial pressure. However, assessing tissue oxygenation solely with transcranial Doppler&#xD;
        ultrasonography is not feasible.&#xD;
  &#xD;
        Near-Infrared Spectroscopy (NIRS) can play an effective role in showing tissue oxygen&#xD;
        perfusion for this purpose. NIRS imaging, similar to pulse oximetry, utilizes infrared light&#xD;
        between 650 and 1000 nm to measure oxyhemoglobin levels in tissues and capillaries. Its&#xD;
        non-invasiveness, ease of tolerance by the patient, and ability to quickly detect sudden&#xD;
        drops in oxygen levels in tissues make it reliable.&#xD;
  &#xD;
        In this study, Researchers aimed at implementing in patients planned for laparoscopic&#xD;
        cholecystectomy, intend to use TCD and NIRS protocols to detect changes in intracranial blood&#xD;
        flow and cerebral tissue oxygenation during the preoperative, intraoperative, and&#xD;
        postoperative periods.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">January 18, 2023</start_date>
    <completion_date type="Anticipated">June 26, 2024</completion_date>
    <primary_completion_date type="Anticipated">June 1, 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>1 Day</target_duration>
    <primary_outcome>
      <measure>Detecting Cerebral Blood Flow Changes at Pneumoperitoneum Time via New Assessment Methods</measure>
      <time_frame>Perioperative Time in Laparoscopic Cholecystectomy Surgery Procedures</time_frame>
      <description>In this study, aimed at patients scheduled for laparoscopic cholecystectomy, Researchers intend to utilize transcranial doppler ultrasonography to detect changes in intracranial blood flow changes during the preoperative, intraoperative, and postoperative periods.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Detecting Cerebral Tissue Oxygenisation Changes at Pneumoperitoneum Time via New Assessment Methods</measure>
      <time_frame>Perioperative Time in Laparoscopic Cholecystectomy Surgery Procedures</time_frame>
      <description>In this study, aimed at patients scheduled for laparoscopic cholecystectomy, Researchers intend to utilize Near Infrared spectrophotometry methods to detect oxygenisation changes in cerebral hemispheres during the preoperative, intraoperative, and postoperative periods.</description>
    </primary_outcome>
    <other_outcome>
      <measure>Detecting any difference between Near Infrared Spectrophotomery and Transcranial Doppler</measure>
      <time_frame>Perioperative Time in Laparoscopic Cholecystectomy Surgery Procedures</time_frame>
      <description>Researchers will compete Near Infrared spectrophotometry and transcranial doppler ultrasonography methods in cerebral hemodynamics in perioperative process in laparoscopic cholecystectomy patients.</description>
    </other_outcome>
    <number_of_groups>7</number_of_groups>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Cerebral Hypoperfusion</condition>
    <condition>Cerebral Occlusion</condition>
    <condition>Cholecystitis; Gallstone</condition>
    <condition>Cholecystitis/Cholelithiasis</condition>
    <arm_group>
      <arm_group_label>Preoperative Assessment of Trail Group</arm_group_label>
    </arm_group>
    <arm_group>
      <arm_group_label>Post-Anaesthetic Induction Assessment of Trial Groups</arm_group_label>
    </arm_group>
    <arm_group>
      <arm_group_label>After Pneumoperitoneum Assessment of Trial Groups</arm_group_label>
    </arm_group>
    <arm_group>
      <arm_group_label>Within Head-up Tilt Position Assessment of Trial Groups</arm_group_label>
    </arm_group>
    <arm_group>
      <arm_group_label>Neuralized Position Assessment of Trial Groups</arm_group_label>
    </arm_group>
    <arm_group>
      <arm_group_label>Within Deflation of Abdomen Assessment of Trial Groups</arm_group_label>
    </arm_group>
    <arm_group>
      <arm_group_label>Awaking Period from Anaesthesia Assessment of Trial Groups</arm_group_label>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Near Infrared Spectrophotometry Device, Transcranial Doppler Ultrasonography</intervention_name>
      <description>We will get signals from the NIRS probes which are positioned bitemporal region of forehead in same time testing intracranial blood flow via TCD device.</description>
      <arm_group_label>After Pneumoperitoneum Assessment of Trial Groups</arm_group_label>
      <arm_group_label>Awaking Period from Anaesthesia Assessment of Trial Groups</arm_group_label>
      <arm_group_label>Neuralized Position Assessment of Trial Groups</arm_group_label>
      <arm_group_label>Post-Anaesthetic Induction Assessment of Trial Groups</arm_group_label>
      <arm_group_label>Preoperative Assessment of Trail Group</arm_group_label>
      <arm_group_label>Within Deflation of Abdomen Assessment of Trial Groups</arm_group_label>
      <arm_group_label>Within Head-up Tilt Position Assessment of Trial Groups</arm_group_label>
      <other_name>NIRS</other_name>
      <other_name>iNVOS Spectrophotometry</other_name>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients who has;&#xD;
  &#xD;
            -  Cholelithiasis,&#xD;
  &#xD;
            -  Gallbladder Stones,&#xD;
  &#xD;
            -  Diagnosed with acute cholecystitis&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients with American Society of Anesthesiology (ASA) 1-3 classification,&#xD;
  &#xD;
            -  Both male and female patients between the ages of 18 to 65,&#xD;
  &#xD;
            -  Patients scheduled for elective laparoscopic cholecystectomy.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  American Society of Anesthesiology (ASA) 4 and above patient groups,&#xD;
  &#xD;
            -  Patients aged under 18 and over 65,&#xD;
  &#xD;
            -  Patients with a history of known previous cerebrovascular accident (CVA),&#xD;
  &#xD;
            -  Patients with follow-up due to Cerebrovascular Ischemic Brain Attack Syndrome (CIBAS),&#xD;
  &#xD;
            -  Patients diagnosed with Carotid Stenosis,&#xD;
  &#xD;
            -  Patients diagnosed with peripheral and central vascular diseases,&#xD;
  &#xD;
            -  Patients with general debilitation and extreme senility,&#xD;
  &#xD;
            -  Cases that require conversion to laparotomy during the intraoperative period.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Kadir Bugra Basaran</last_name>
      <role>Study Chair</role>
      <affiliation>Uludag University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Kadir Bugra Basaran</last_name>
      <phone>+905422780016</phone>
      <email>kbugrabasaran@gmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Bursa Uludag University, Faculty of Medicine, Department of Anesthesiology and Reanimation</name>
        <address>
          <city>Bursa</city>
          <state>Nilufer</state>
          <zip>16285</zip>
          <country>Turkey</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Kadir Bugra Basaran, M.D.</last_name>
        <phone>+905422780016</phone>
        <email>kbugrabasaran@gmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 30, 2023</study_first_submitted>
    <study_first_submitted_qc>September 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 14, 2023</study_first_posted>
    <last_update_submitted>September 6, 2023</last_update_submitted>
    <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Uludag University</investigator_affiliation>
      <investigator_full_name>Kadir Bugra Basaran</investigator_full_name>
      <investigator_title>Medical Doctor, Research Assistant at Department of Anesthesiology and Reanimation</investigator_title>
    </responsible_party>
    <keyword>Near Infra-Red Spectrophotometry</keyword>
    <keyword>Cerebral Oxygenisation</keyword>
    <keyword>Transcranial Doppler Ultrasonography (TCD)</keyword>
    <keyword>Laparoscopic Surgery</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Cholecystitis</mesh_term>
      <mesh_term>Acalculous Cholecystitis</mesh_term>
      <mesh_term>Gallstones</mesh_term>
      <mesh_term>Cholelithiasis</mesh_term>
      <mesh_term>Cholecystolithiasis</mesh_term>
    </condition_browse>
    <!-- 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/NCT06036498
  org study id: Bursa Uludag Universitesi
  nct id: NCT06036498
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  The goal of this clinical trial is to test intracranial blood flow and cerebral oxygenisation
        changes in patients who have pneumoperitoneum in laparoscopic cholecystectomy procedure.
  
        The main questions aim to answer are:
  
          -  How does pneumoperitoneum in laparoscopic cholecystectomy procedure changes blod flow in
             patients?
  
          -  Are there any differences between Near-Red spectroscopy and transcranial doppler
             ultrasonography assesment?
  
        Participants will be diagnosed with using NIRS probes and Doppler ultrasonography probes if
        any changes in surgical procedure.
  
        Researchers will compare NIRS and TCD detection outcomes to see if there is any differences.
  Laparoscopic cholecystectomy is the gold standard treatment method for benign gallbladder
        stones. The required pneumoperitoneum for the operation leads to hemodynamic and metabolic
        changes in patients. Prolonged complicated laparoscopic surgeries also pose an additional
        risk factor for neurological complications.
  
        Cerebral circulation occurs within a closed environment enclosed by the skull. This
        environment includes brain tissue, blood volume, and cerebrospinal fluid. Cerebral blood
        pressure arises from the difference between arterial blood pressure and intracranial
        pressure. Due to carbondioxide insufflation in laparoscopic surgery, caused by
        pneumoperitoneum creation, intra-abdominal carbondioxide is rapidly absorbed through the
        peritoneal membrane and enters the bloodstream.
  
        Carbonic acid formed by the carbonic anhydrase enzyme in the plasma leads to respiratory
        acidosis. The resulting respiratory acidosis triggers peripheral and central vasodilation to
        ensure oxygenation and gas exchange, causing a rightward shift in the hemoglobin curve.
        Hypercarbia's impact on cells and the effect of cellular acidosis lead to local tissue edema.
        All of these factors contribute to changes in transcranial pressure. An increase in
        intracranial pressure can result in impaired cerebral perfusion.
  
        Transcranial Doppler (TCD) is a reliable tool for imaging intracranial pressure due to its
        affordability, non-invasiveness, repeatability at the bedside, and real-time data provision
        during acute situations. Transcranial Doppler ultrasonography (TCD) can better display flow
        velocity waveforms, flow direction, intraparenchymal flow velocity, and density compared to
        other diagnostic tests. Changes in waveforms detected by TCD allow tracking changes in
        intracranial pressure. However, assessing tissue oxygenation solely with transcranial Doppler
        ultrasonography is not feasible.
  
        Near-Infrared Spectroscopy (NIRS) can play an effective role in showing tissue oxygen
        perfusion for this purpose. NIRS imaging, similar to pulse oximetry, utilizes infrared light
        between 650 and 1000 nm to measure oxyhemoglobin levels in tissues and capillaries. Its
        non-invasiveness, ease of tolerance by the patient, and ability to quickly detect sudden
        drops in oxygen levels in tissues make it reliable.
  
        In this study, Researchers aimed at implementing in patients planned for laparoscopic
        cholecystectomy, intend to use TCD and NIRS protocols to detect changes in intracranial blood
        flow and cerebral tissue oxygenation during the preoperative, intraoperative, and
        postoperative periods.
  observational model: Cohort
  time perspective: Prospective
  measure: Detecting Cerebral Blood Flow Changes at Pneumoperitoneum Time via New Assessment Methods
  time frame: Perioperative Time in Laparoscopic Cholecystectomy Surgery Procedures
  description: In this study, aimed at patients scheduled for laparoscopic cholecystectomy, Researchers intend to utilize transcranial doppler ultrasonography to detect changes in intracranial blood flow changes during the preoperative, intraoperative, and postoperative periods.
  measure: Detecting Cerebral Tissue Oxygenisation Changes at Pneumoperitoneum Time via New Assessment Methods
  time frame: Perioperative Time in Laparoscopic Cholecystectomy Surgery Procedures
  description: In this study, aimed at patients scheduled for laparoscopic cholecystectomy, Researchers intend to utilize Near Infrared spectrophotometry methods to detect oxygenisation changes in cerebral hemispheres during the preoperative, intraoperative, and postoperative periods.
  measure: Detecting any difference between Near Infrared Spectrophotomery and Transcranial Doppler
  time frame: Perioperative Time in Laparoscopic Cholecystectomy Surgery Procedures
  description: Researchers will compete Near Infrared spectrophotometry and transcranial doppler ultrasonography methods in cerebral hemodynamics in perioperative process in laparoscopic cholecystectomy patients.
  arm group label: Preoperative Assessment of Trail Group
  arm group label: Post-Anaesthetic Induction Assessment of Trial Groups
  arm group label: After Pneumoperitoneum Assessment of Trial Groups
  arm group label: Within Head-up Tilt Position Assessment of Trial Groups
  arm group label: Neuralized Position Assessment of Trial Groups
  arm group label: Within Deflation of Abdomen Assessment of Trial Groups
  arm group label: Awaking Period from Anaesthesia Assessment of Trial Groups
  intervention type: Device
  intervention name: Near Infrared Spectrophotometry Device, Transcranial Doppler Ultrasonography
  description: We will get signals from the NIRS probes which are positioned bitemporal region of forehead in same time testing intracranial blood flow via TCD device.
  arm group label: After Pneumoperitoneum Assessment of Trial Groups
  arm group label: Awaking Period from Anaesthesia Assessment of Trial Groups
  arm group label: Neuralized Position Assessment of Trial Groups
  arm group label: Post-Anaesthetic Induction Assessment of Trial Groups
  arm group label: Preoperative Assessment of Trail Group
  arm group label: Within Deflation of Abdomen Assessment of Trial Groups
  arm group label: Within Head-up Tilt Position Assessment of Trial Groups
  other name: NIRS
  other name: iNVOS Spectrophotometry
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Kadir Bugra Basaran
  role: Study Chair
  affiliation: Uludag University
  last name: Kadir Bugra Basaran
  phone: +905422780016
  email: kbugrabasaran@gmail.com
  facility: 
  status: Recruiting
  contact: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Uludag University
  investigator full name: Kadir Bugra Basaran
  investigator title: Medical Doctor, Research Assistant at Department of Anesthesiology and Reanimation
  mesh term: Cholecystitis
  mesh term: Acalculous Cholecystitis
  mesh term: Gallstones
  mesh term: Cholelithiasis
  mesh term: Cholecystolithiasis