<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/NCT04491032</url>
  </required_header>
  <id_info>
    <org_study_id>72109855-604.01.01-10728</org_study_id>
    <nct_id>NCT04491032</nct_id>
  </id_info>
  <brief_title>Pediatric Caudal Injection Volume on Optic Nerve Sheath Diameter and Cerebral Oxygenation</brief_title>
  <official_title>The Effect of Caudal Epidural Injection Volume on Optic Nerve Sheath Diameter and Cerebral Oxygenation in Pediatric Cases</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aybike Onur Gönen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Pinar Kendigelen</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ayse Cigdem Tutuncu</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Kaya, Guner, M.D.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Senol Emre</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Rahsan Ozcan</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Istanbul 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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Caudal anesthesia is a commonly used neuraxial anesthesia method for children. Injection of a&#xD;
      certain volume of fluid into the epidural space for cauda anesthesia may push some&#xD;
      cerebrospinal fluid towards the head, which may lead to mild increase of pressures inside the&#xD;
      head. Such mild changes are compensated well by healthy individuals and no clinical sequel is&#xD;
      seen, however at-risk populations may be affected. We aim to see how different amounts of&#xD;
      fluid injected into the epidural space may change two clinical parameters affected by&#xD;
      intracranial pressure to determine if a lower volume is safer than a higher one.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Caudal epidural injection of local anesthetic solution is a common neuraxial anesthesia&#xD;
      technique that provides excellent peri-operative analgesia in children. Unfused sacral hiatus&#xD;
      allows for easy and safe access into the epidural space. Anatomically, injection of a certain&#xD;
      volume of fluid over the dural sac inside the closed spinal canal can push the cerebrospinal&#xD;
      fluid cranially. This push may lead to increased intracranial pressure. We will measure two&#xD;
      findings affected by intracranial pressure (optic nerve sheath diameter and cerebral&#xD;
      oxygenation) and compare the effects of two different volumes of caudal injections on these&#xD;
      measures.&#xD;
&#xD;
      Children with closed fontanelles and scheduled to undergo elective surgery, for which caudal&#xD;
      anesthesia is an effective method for peri-operative analgesia, will be recruited for this&#xD;
      study. Injection volume will be determined depending on the level of analgesia required for&#xD;
      the surgical procedure. Ultrasonographic measurements of optic nerve sheath diameter and&#xD;
      near-infrared spectrometry measurement of cerebral oxygenation will be taken before and after&#xD;
      caudal anesthesia.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 15, 2019</start_date>
  <completion_date type="Actual">March 15, 2022</completion_date>
  <primary_completion_date type="Actual">March 15, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Patients will receive either a low or high volume of caudal injection.</intervention_model_description>
    <primary_purpose>Screening</primary_purpose>
    <masking>Triple (Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>Investigator, who will take and record the measurements, will not know about the volume of caudal injection. Another investigator will analyze the ultrasonography images without any knowledge of the patient or the intervention.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in optic nerve sheath diameter</measure>
    <time_frame>From before caudal injection to immediately, 10 min, 20 min and 30 min after.</time_frame>
    <description>Difference in the percentage change of ultrasonographic measurement of optic nerve sheath diameter between groups</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in cerebral oxygenation</measure>
    <time_frame>From before caudal injection to immediately, 10 min, 20 min and 30 min after.</time_frame>
    <description>Difference in the change in near-infrared spectrometry measurement of cerebral oxygenation between the groups</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Variation in optic nerve sheath diameter</measure>
    <time_frame>From before caudal injection to immediately, 10 min, 20 min and 30 min after.</time_frame>
    <description>Difference in the percentage change of ultrasonographic measurement of optic nerve sheath diameter in each group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Variation in cerebral oxygenation</measure>
    <time_frame>From before caudal injection to immediately, 10 min, 20 min and 30 min after.</time_frame>
    <description>Difference in the change in near-infrared spectrometry measurement of cerebral oxygenation in each group</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Changes in hemodynamic and respiratory parameters</measure>
    <time_frame>From before caudal injection to immediately, 10 min, 20 min and 30 min after.</time_frame>
    <description>Mean arterial pressure, heart rate, end-tidal carbondioxide pressure, peak inspiratory pressure, peripheral oxygen saturation, oxygen fraction of inhaled gas</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">58</enrollment>
  <condition>Anesthesia, Caudal</condition>
  <condition>Pediatrics</condition>
  <condition>Elevated Intracranial Pressure</condition>
  <arm_group>
    <arm_group_label>Low Volume</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Caudal anesthesia will be performed with 0.8 ml/kg of the local anesthetic solution</description>
  </arm_group>
  <arm_group>
    <arm_group_label>High Volume</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Caudal anesthesia will be performed with 1.25 ml/kg of the local anesthetic solution</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Caudal anesthesia</intervention_name>
    <description>Caudal epidural injection will be performed after induction of general anesthesia.</description>
    <arm_group_label>High Volume</arm_group_label>
    <arm_group_label>Low Volume</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ASA class 1 or 2&#xD;
&#xD;
          -  Scheduled for elective surgery suitable for caudal anesthesia&#xD;
&#xD;
          -  Parental/guardian consent for caudal anesthesia and measurements obtained&#xD;
&#xD;
          -  Closed fontanelles&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Open fontanelle&#xD;
&#xD;
          -  Parental/guardian refusal&#xD;
&#xD;
          -  Previous intracranial or ocular pathology&#xD;
&#xD;
          -  Coagulapathies&#xD;
&#xD;
          -  Variations in gross and ultrasonographic sacral anatomy&#xD;
&#xD;
          -  Block performence to end of surgery expected to last less than 30 minutes&#xD;
&#xD;
          -  Block volumes more than 30ml needed&#xD;
&#xD;
          -  Laparoscopic surgery&#xD;
&#xD;
          -  Need for long term analgesia with epidural catheter&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Months</minimum_age>
    <maximum_age>8 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Aybike Onur Gönen, MD</last_name>
    <role>Study Director</role>
    <affiliation>Istanbul University - Cerrahpasa (IUC)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Istanbul University Cerrahpasa</name>
      <address>
        <city>Istanbul</city>
        <zip>34098</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>July 27, 2020</study_first_submitted>
  <study_first_submitted_qc>July 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 29, 2020</study_first_posted>
  <last_update_submitted>June 29, 2022</last_update_submitted>
  <last_update_submitted_qc>June 29, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 30, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Istanbul University</investigator_affiliation>
    <investigator_full_name>Aybike Onur Gönen</investigator_full_name>
    <investigator_title>Resident in Anesthesiology and Intensive Care</investigator_title>
  </responsible_party>
  <keyword>optic nerve sheath diameter</keyword>
  <keyword>cerebral oximetry</keyword>
  <keyword>caudal epidural anesthesia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Intracranial Hypertension</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anesthetics</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>No formal plans to share IPD is made</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/NCT04491032
org study id: 72109855-604.01.01-10728
nct id: NCT04491032
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Caudal anesthesia is a commonly used neuraxial anesthesia method for children. Injection of a
      certain volume of fluid into the epidural space for cauda anesthesia may push some
      cerebrospinal fluid towards the head, which may lead to mild increase of pressures inside the
      head. Such mild changes are compensated well by healthy individuals and no clinical sequel is
      seen, however at-risk populations may be affected. We aim to see how different amounts of
      fluid injected into the epidural space may change two clinical parameters affected by
      intracranial pressure to determine if a lower volume is safer than a higher one.
Caudal epidural injection of local anesthetic solution is a common neuraxial anesthesia
      technique that provides excellent peri-operative analgesia in children. Unfused sacral hiatus
      allows for easy and safe access into the epidural space. Anatomically, injection of a certain
      volume of fluid over the dural sac inside the closed spinal canal can push the cerebrospinal
      fluid cranially. This push may lead to increased intracranial pressure. We will measure two
      findings affected by intracranial pressure (optic nerve sheath diameter and cerebral
      oxygenation) and compare the effects of two different volumes of caudal injections on these
      measures.

      Children with closed fontanelles and scheduled to undergo elective surgery, for which caudal
      anesthesia is an effective method for peri-operative analgesia, will be recruited for this
      study. Injection volume will be determined depending on the level of analgesia required for
      the surgical procedure. Ultrasonographic measurements of optic nerve sheath diameter and
      near-infrared spectrometry measurement of cerebral oxygenation will be taken before and after
      caudal anesthesia.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Patients will receive either a low or high volume of caudal injection.
primary purpose: Screening
masking: Triple (Care Provider, Investigator, Outcomes Assessor)
masking description: Investigator, who will take and record the measurements, will not know about the volume of caudal injection. Another investigator will analyze the ultrasonography images without any knowledge of the patient or the intervention.
measure: Change in optic nerve sheath diameter
time frame: From before caudal injection to immediately, 10 min, 20 min and 30 min after.
description: Difference in the percentage change of ultrasonographic measurement of optic nerve sheath diameter between groups
measure: Change in cerebral oxygenation
time frame: From before caudal injection to immediately, 10 min, 20 min and 30 min after.
description: Difference in the change in near-infrared spectrometry measurement of cerebral oxygenation between the groups
measure: Variation in optic nerve sheath diameter
time frame: From before caudal injection to immediately, 10 min, 20 min and 30 min after.
description: Difference in the percentage change of ultrasonographic measurement of optic nerve sheath diameter in each group
measure: Variation in cerebral oxygenation
time frame: From before caudal injection to immediately, 10 min, 20 min and 30 min after.
description: Difference in the change in near-infrared spectrometry measurement of cerebral oxygenation in each group
measure: Changes in hemodynamic and respiratory parameters
time frame: From before caudal injection to immediately, 10 min, 20 min and 30 min after.
description: Mean arterial pressure, heart rate, end-tidal carbondioxide pressure, peak inspiratory pressure, peripheral oxygen saturation, oxygen fraction of inhaled gas
arm group label: Low Volume
arm group type: Active Comparator
description: Caudal anesthesia will be performed with 0.8 ml/kg of the local anesthetic solution
arm group label: High Volume
arm group type: Active Comparator
description: Caudal anesthesia will be performed with 1.25 ml/kg of the local anesthetic solution
intervention type: Procedure
intervention name: Caudal anesthesia
description: Caudal epidural injection will be performed after induction of general anesthesia.
arm group label: High Volume
arm group label: Low Volume
criteria: 
gender: All
minimum age: 12 Months
maximum age: 8 Years
healthy volunteers: No
last name: Aybike Onur Gönen, MD
role: Study Director
affiliation: Istanbul University - Cerrahpasa (IUC)
facility: 
country: Turkey
responsible party type: Sponsor-Investigator
investigator affiliation: Istanbul University
investigator full name: Aybike Onur Gönen
investigator title: Resident in Anesthesiology and Intensive Care
mesh term: Intracranial Hypertension
mesh term: Anesthetics
sharing ipd: No
ipd description: No formal plans to share IPD is made