<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/NCT04415905</url>
  </required_header>
  <id_info>
    <org_study_id>4-2020-0061</org_study_id>
    <nct_id>NCT04415905</nct_id>
  </id_info>
  <brief_title>Comparison of Optic Nerve Sheath Diameter in Children Receiving Caudal Block According to Anesthetic Agents: Total Intravenous Anesthesia vs. Volatile Anesthesia</brief_title>
  <official_title>Comparison of Optic Nerve Sheath Diameter in Children Receiving Caudal Block According to Anesthetic Agents: Total Intravenous Anesthesia vs. Volatile Anesthesia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yonsei University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yonsei 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 block is commonly used for postoperative analgesia in paediatric patients. A higher&#xD;
      volume (1.5 ml/kg) of local anaesthetic for caudal block has been reported to not only&#xD;
      increase the level of cranial spread but also provide better quality and longer duration of&#xD;
      analgesia in comparison with the conventional volume (1.0 ml/kg). However, caudal block with&#xD;
      a high volume of local anaesthetic can increase intracranial pressure (ICP). Previous studies&#xD;
      have shown that propofol anesthesia lowers ICP when compared with volatile anesthesia.&#xD;
      Therefore, this study was designed to test if propofol can reduce the magnitude of ICP&#xD;
      increase following caudal block when compared with a volatile anesthetic, sevoflurane. There&#xD;
      is increasing evidence that optic nerve sheath diameter (ONSD) measured by ultrasonography&#xD;
      correlates with degree of ICP and is able to detect intracranial hypertension. Therefore,&#xD;
      ONSD will be measured as a surrogate of ICP.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Equal number of patients are randomly assigned to the P or S group. The participants in the P&#xD;
      and S group are anesthetized with propofol and sevoflurane, respectively. Irrespective of&#xD;
      assigned group, all participants receive caudal block with 1.5 ml/kg of 0.15% ropivacaine (up&#xD;
      to 30 ml per individual participant). All anesthetic procedures except for main anesthetic&#xD;
      agent are the same in all participants. ONSD is measured at the following time points: before&#xD;
      (T0), immediately after (T1), and 10 min (T2) and 30 min(T3) after caudal block. Two&#xD;
      measurements of each optic nerve sheath are acquired in each eye. The mean value of the four&#xD;
      measurements is considered as the ONSD at each time point.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 22, 2020</start_date>
  <completion_date type="Actual">March 2, 2022</completion_date>
  <primary_completion_date type="Actual">March 2, 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>There are 2 groups according to the type of main anesthetic agent. P group are anesthetized with propofol, so are S group with sevoflurane.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Anesthesia machine and infusion pumps are shielded from assessors who measure ONSD.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>ONSD</measure>
    <time_frame>before (T0) caudal block.</time_frame>
    <description>ONSD is a surrogate for ICP. ONSD was measured by transorbital sonography. Transorbital sonography is performed using a linear 6-13 Hz probe. After applying a thick layer of sterile coupling gel on the closed upper eyelid, the probe is placed gently without exerting pressure. Axial images of the orbit are acquired in the plane of the optic nerve, and ONSD is measured 3mm posterior to the optic nerve head as described previously.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>ONSD</measure>
    <time_frame>immediately after (T1) caudal block.</time_frame>
    <description>ONSD is a surrogate for ICP. ONSD was measured by transorbital sonography. Transorbital sonography is performed using a linear 6-13 Hz probe. After applying a thick layer of sterile coupling gel on the closed upper eyelid, the probe is placed gently without exerting pressure. Axial images of the orbit are acquired in the plane of the optic nerve, and ONSD is measured 3mm posterior to the optic nerve head as described previously.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>ONSD</measure>
    <time_frame>10 minutes (T2) after caudal block.</time_frame>
    <description>ONSD is a surrogate for ICP. ONSD was measured by transorbital sonography. Transorbital sonography is performed using a linear 6-13 Hz probe. After applying a thick layer of sterile coupling gel on the closed upper eyelid, the probe is placed gently without exerting pressure. Axial images of the orbit are acquired in the plane of the optic nerve, and ONSD is measured 3mm posterior to the optic nerve head as described previously.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>ONSD</measure>
    <time_frame>30 minutes (T3) after caudal block.</time_frame>
    <description>ONSD is a surrogate for ICP. ONSD was measured by transorbital sonography. Transorbital sonography is performed using a linear 6-13 Hz probe. After applying a thick layer of sterile coupling gel on the closed upper eyelid, the probe is placed gently without exerting pressure. Axial images of the orbit are acquired in the plane of the optic nerve, and ONSD is measured 3mm posterior to the optic nerve head as described previously.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The variables affecting ICP : Heart rate (beats per minute)</measure>
    <time_frame>before (T0) caudal block.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The variables affecting ICP : Heart rate (beats per minute)</measure>
    <time_frame>immediately after (T1) caudal block.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The variables affecting ICP : Heart rate (beats per minute)</measure>
    <time_frame>10 minutes (T2) after caudal block.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The variables affecting ICP : Heart rate (beats per minute)</measure>
    <time_frame>30 minutes (T3) after caudal block.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The variables affecting ICP : Mean arterial pressure (mmHg)</measure>
    <time_frame>before (T0) caudal block.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The variables affecting ICP : Mean arterial pressure (mmHg)</measure>
    <time_frame>immediately after (T1) caudal block.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The variables affecting ICP : Mean arterial pressure (mmHg)</measure>
    <time_frame>10 minutes (T2) after caudal block.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The variables affecting ICP : Mean arterial pressure (mmHg)</measure>
    <time_frame>30 minutes (T3) after caudal block.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The variables affecting ICP : End-tidal carbon dioxide partial pressure (mmHg)</measure>
    <time_frame>before (T0) caudal block.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The variables affecting ICP : End-tidal carbon dioxide partial pressure (mmHg)</measure>
    <time_frame>immediately after (T1) caudal block.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The variables affecting ICP : End-tidal carbon dioxide partial pressure (mmHg)</measure>
    <time_frame>10 minutes (T2) after caudal block.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The variables affecting ICP : End-tidal carbon dioxide partial pressure (mmHg)</measure>
    <time_frame>30 minutes (T3) after caudal block.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The variables affecting ICP : End-tidal sevoflurane concentration (volume %)</measure>
    <time_frame>before (T0) caudal block.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The variables affecting ICP : End-tidal sevoflurane concentration (volume %)</measure>
    <time_frame>immediately after (T1) caudal block.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The variables affecting ICP : End-tidal sevoflurane concentration (volume %)</measure>
    <time_frame>10 minutes (T2) after caudal block.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The variables affecting ICP : End-tidal sevoflurane concentration (volume %)</measure>
    <time_frame>30 minutes (T3) after caudal block.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The variables affecting ICP : Estimated propofol effect-site concentration (μg/ml)</measure>
    <time_frame>before (T0) caudal block.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The variables affecting ICP : Estimated propofol effect-site concentration (μg/ml)</measure>
    <time_frame>immediately after (T1) caudal block.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The variables affecting ICP : Estimated propofol effect-site concentration (μg/ml)</measure>
    <time_frame>10 minutes (T2) after caudal block.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The variables affecting ICP : Estimated propofol effect-site concentration (μg/ml)</measure>
    <time_frame>30 minutes (T3) after caudal block.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The variables affecting ICP : Body temperature (℃)</measure>
    <time_frame>before (T0) caudal block.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The variables affecting ICP : Body temperature (℃)</measure>
    <time_frame>immediately after (T1) caudal block.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The variables affecting ICP : Body temperature (℃)</measure>
    <time_frame>10 minutes (T2) after caudal block.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The variables affecting ICP : Body temperature (℃)</measure>
    <time_frame>30 minutes (T3) after caudal block.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The variables affecting ICP : Peak inspiratory pressure (mmHg)</measure>
    <time_frame>before (T0) caudal block.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The variables affecting ICP : Peak inspiratory pressure (mmHg)</measure>
    <time_frame>immediately after (T1) caudal block.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The variables affecting ICP : Peak inspiratory pressure (mmHg)</measure>
    <time_frame>10 minutes (T2) after caudal block.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The variables affecting ICP : Peak inspiratory pressure (mmHg)</measure>
    <time_frame>30 minutes (T3) after caudal block.</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Caudal Block for Postoperative Analgesia</condition>
  <arm_group>
    <arm_group_label>group P</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The participants in the group P are anesthetized with propofol.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>group S</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The participants in the group S are anesthetized with sevoflurane.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Propofol</intervention_name>
    <description>The participants in the group P are anesthetized with propofol</description>
    <arm_group_label>group P</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sevoflurane</intervention_name>
    <description>The participants in the group S are anesthetized with sevoflurane.</description>
    <arm_group_label>group S</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Among children undergoing urological surgery, patients, 36 to 72-months-old&#xD;
&#xD;
          -  Body weight less than 20 kg (The limit on body weight is set because the maximum&#xD;
             volume of local anaesthetic for caudal block in children is restricted to 30 ml.)&#xD;
&#xD;
          -  Treatment plan for caudal block for analgesia, are enrolled.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Symptoms or signs of spinal anomalies or infection at the sacral region&#xD;
&#xD;
          -  Coagulopathy&#xD;
&#xD;
          -  Increased ICP&#xD;
&#xD;
          -  Ophthalmic diseases&#xD;
&#xD;
          -  History of increased ICP&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>5 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>May 28, 2020</study_first_submitted>
  <study_first_submitted_qc>June 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>May 4, 2022</last_update_submitted>
  <last_update_submitted_qc>May 4, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 5, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Caudal block</keyword>
  <keyword>Intracranial pressure</keyword>
  <keyword>Propofol</keyword>
  <keyword>Sevoflurane</keyword>
  <keyword>Ultrasound</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Propofol</mesh_term>
    <mesh_term>Sevoflurane</mesh_term>
  </intervention_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/NCT04415905
org study id: 4-2020-0061
nct id: NCT04415905
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Caudal block is commonly used for postoperative analgesia in paediatric patients. A higher
      volume (1.5 ml/kg) of local anaesthetic for caudal block has been reported to not only
      increase the level of cranial spread but also provide better quality and longer duration of
      analgesia in comparison with the conventional volume (1.0 ml/kg). However, caudal block with
      a high volume of local anaesthetic can increase intracranial pressure (ICP). Previous studies
      have shown that propofol anesthesia lowers ICP when compared with volatile anesthesia.
      Therefore, this study was designed to test if propofol can reduce the magnitude of ICP
      increase following caudal block when compared with a volatile anesthetic, sevoflurane. There
      is increasing evidence that optic nerve sheath diameter (ONSD) measured by ultrasonography
      correlates with degree of ICP and is able to detect intracranial hypertension. Therefore,
      ONSD will be measured as a surrogate of ICP.
Equal number of patients are randomly assigned to the P or S group. The participants in the P
      and S group are anesthetized with propofol and sevoflurane, respectively. Irrespective of
      assigned group, all participants receive caudal block with 1.5 ml/kg of 0.15% ropivacaine (up
      to 30 ml per individual participant). All anesthetic procedures except for main anesthetic
      agent are the same in all participants. ONSD is measured at the following time points: before
      (T0), immediately after (T1), and 10 min (T2) and 30 min(T3) after caudal block. Two
      measurements of each optic nerve sheath are acquired in each eye. The mean value of the four
      measurements is considered as the ONSD at each time point.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: There are 2 groups according to the type of main anesthetic agent. P group are anesthetized with propofol, so are S group with sevoflurane.
primary purpose: Other
masking: Single (Outcomes Assessor)
masking description: Anesthesia machine and infusion pumps are shielded from assessors who measure ONSD.
measure: ONSD
time frame: before (T0) caudal block.
description: ONSD is a surrogate for ICP. ONSD was measured by transorbital sonography. Transorbital sonography is performed using a linear 6-13 Hz probe. After applying a thick layer of sterile coupling gel on the closed upper eyelid, the probe is placed gently without exerting pressure. Axial images of the orbit are acquired in the plane of the optic nerve, and ONSD is measured 3mm posterior to the optic nerve head as described previously.
measure: ONSD
time frame: immediately after (T1) caudal block.
description: ONSD is a surrogate for ICP. ONSD was measured by transorbital sonography. Transorbital sonography is performed using a linear 6-13 Hz probe. After applying a thick layer of sterile coupling gel on the closed upper eyelid, the probe is placed gently without exerting pressure. Axial images of the orbit are acquired in the plane of the optic nerve, and ONSD is measured 3mm posterior to the optic nerve head as described previously.
measure: ONSD
time frame: 10 minutes (T2) after caudal block.
description: ONSD is a surrogate for ICP. ONSD was measured by transorbital sonography. Transorbital sonography is performed using a linear 6-13 Hz probe. After applying a thick layer of sterile coupling gel on the closed upper eyelid, the probe is placed gently without exerting pressure. Axial images of the orbit are acquired in the plane of the optic nerve, and ONSD is measured 3mm posterior to the optic nerve head as described previously.
measure: ONSD
time frame: 30 minutes (T3) after caudal block.
description: ONSD is a surrogate for ICP. ONSD was measured by transorbital sonography. Transorbital sonography is performed using a linear 6-13 Hz probe. After applying a thick layer of sterile coupling gel on the closed upper eyelid, the probe is placed gently without exerting pressure. Axial images of the orbit are acquired in the plane of the optic nerve, and ONSD is measured 3mm posterior to the optic nerve head as described previously.
measure: The variables affecting ICP : Heart rate (beats per minute)
time frame: before (T0) caudal block.
measure: The variables affecting ICP : Heart rate (beats per minute)
time frame: immediately after (T1) caudal block.
measure: The variables affecting ICP : Heart rate (beats per minute)
time frame: 10 minutes (T2) after caudal block.
measure: The variables affecting ICP : Heart rate (beats per minute)
time frame: 30 minutes (T3) after caudal block.
measure: The variables affecting ICP : Mean arterial pressure (mmHg)
time frame: before (T0) caudal block.
measure: The variables affecting ICP : Mean arterial pressure (mmHg)
time frame: immediately after (T1) caudal block.
measure: The variables affecting ICP : Mean arterial pressure (mmHg)
time frame: 10 minutes (T2) after caudal block.
measure: The variables affecting ICP : Mean arterial pressure (mmHg)
time frame: 30 minutes (T3) after caudal block.
measure: The variables affecting ICP : End-tidal carbon dioxide partial pressure (mmHg)
time frame: before (T0) caudal block.
measure: The variables affecting ICP : End-tidal carbon dioxide partial pressure (mmHg)
time frame: immediately after (T1) caudal block.
measure: The variables affecting ICP : End-tidal carbon dioxide partial pressure (mmHg)
time frame: 10 minutes (T2) after caudal block.
measure: The variables affecting ICP : End-tidal carbon dioxide partial pressure (mmHg)
time frame: 30 minutes (T3) after caudal block.
measure: The variables affecting ICP : End-tidal sevoflurane concentration (volume %)
time frame: before (T0) caudal block.
measure: The variables affecting ICP : End-tidal sevoflurane concentration (volume %)
time frame: immediately after (T1) caudal block.
measure: The variables affecting ICP : End-tidal sevoflurane concentration (volume %)
time frame: 10 minutes (T2) after caudal block.
measure: The variables affecting ICP : End-tidal sevoflurane concentration (volume %)
time frame: 30 minutes (T3) after caudal block.
measure: The variables affecting ICP : Estimated propofol effect-site concentration (μg/ml)
time frame: before (T0) caudal block.
measure: The variables affecting ICP : Estimated propofol effect-site concentration (μg/ml)
time frame: immediately after (T1) caudal block.
measure: The variables affecting ICP : Estimated propofol effect-site concentration (μg/ml)
time frame: 10 minutes (T2) after caudal block.
measure: The variables affecting ICP : Estimated propofol effect-site concentration (μg/ml)
time frame: 30 minutes (T3) after caudal block.
measure: The variables affecting ICP : Body temperature (℃)
time frame: before (T0) caudal block.
measure: The variables affecting ICP : Body temperature (℃)
time frame: immediately after (T1) caudal block.
measure: The variables affecting ICP : Body temperature (℃)
time frame: 10 minutes (T2) after caudal block.
measure: The variables affecting ICP : Body temperature (℃)
time frame: 30 minutes (T3) after caudal block.
measure: The variables affecting ICP : Peak inspiratory pressure (mmHg)
time frame: before (T0) caudal block.
measure: The variables affecting ICP : Peak inspiratory pressure (mmHg)
time frame: immediately after (T1) caudal block.
measure: The variables affecting ICP : Peak inspiratory pressure (mmHg)
time frame: 10 minutes (T2) after caudal block.
measure: The variables affecting ICP : Peak inspiratory pressure (mmHg)
time frame: 30 minutes (T3) after caudal block.
arm group label: group P
arm group type: Experimental
description: The participants in the group P are anesthetized with propofol.
arm group label: group S
arm group type: Active Comparator
description: The participants in the group S are anesthetized with sevoflurane.
intervention type: Drug
intervention name: Propofol
description: The participants in the group P are anesthetized with propofol
arm group label: group P
intervention type: Drug
intervention name: Sevoflurane
description: The participants in the group S are anesthetized with sevoflurane.
arm group label: group S
criteria: 
gender: All
minimum age: 3 Years
maximum age: 5 Years
healthy volunteers: No
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Propofol
mesh term: Sevoflurane
sharing ipd: No