<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/NCT04427085</url>
  </required_header>
  <id_info>
    <org_study_id>20421</org_study_id>
    <nct_id>NCT04427085</nct_id>
  </id_info>
  <brief_title>Changes of Optic Nerve Sheath Diameter Between Obese and Non-obese Patients Undergoing Laparoscopic Gynecological Surgery</brief_title>
  <official_title>Optic Nerve Sheath Diameter Between Obese and Non-obese Patients Undergoing Laparoscopic Gynecological Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>SMG-SNU Boramae Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>SMG-SNU Boramae Medical Center</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to compare the change of optic nerve sheath diameter in obese and non-obese&#xD;
      patients undergoing laparoscopic gynecological surgery in a steep Trendelenburg position.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">July 2020</start_date>
  <completion_date type="Anticipated">May 2021</completion_date>
  <primary_completion_date type="Anticipated">May 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Optic nerve sheath diameter</measure>
    <time_frame>30 minutes after pneuroperitoneum in the Trendelenburg position</time_frame>
    <description>Using ultrasonography, optic nerve sheath diameter is measured.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Optic nerve sheath diameter</measure>
    <time_frame>15 minutes after pneuroperitoneum in the Trendelenburg position</time_frame>
    <description>Using ultrasonography, optic nerve sheath diameter is measured.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Optic nerve sheath diameter</measure>
    <time_frame>60 minutes after pneuroperitoneum in the Trendelenburg position</time_frame>
    <description>Using ultrasonography, optic nerve sheath diameter is measured.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Optic nerve sheath diameter</measure>
    <time_frame>10 minutes after release of pneumoperitoneum and return to the supine position</time_frame>
    <description>Using ultrasonography, optic nerve sheath diameter is measured.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Optic nerve sheath diameter</measure>
    <time_frame>At 1 hour after completion of surgery</time_frame>
    <description>Using ultrasonography, optic nerve sheath diameter is measured.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Optic nerve sheath diameter</measure>
    <time_frame>At 24 hours after completion of surgery</time_frame>
    <description>Using ultrasonography, optic nerve sheath diameter is measured.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nausea and vomiting</measure>
    <time_frame>At 24 hours after completion of surgery</time_frame>
    <description>The presence and severity of nausea and vomiting is evaluated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Headache</measure>
    <time_frame>At 24 hours after completion of surgery</time_frame>
    <description>The presence and severity of headache is evaluated.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">70</enrollment>
  <condition>Optic Nerve Sheath Diameter</condition>
  <arm_group>
    <arm_group_label>Obese group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>body mass index≥ 30 kg/m2</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-obese group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>BMI &lt; 30 kg/m2</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Ultrasound assessment of optic nerve sheath diameter</intervention_name>
    <description>Using ultrasonography, optic nerve sheath diameter is measured during perioperative period.</description>
    <arm_group_label>Non-obese group</arm_group_label>
    <arm_group_label>Obese group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients undergoing laparoscopic gynecological surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Ophthalmic diseases&#xD;
&#xD;
          -  Previous history of ophthalmic surgery.&#xD;
&#xD;
          -  Neurological disorders&#xD;
&#xD;
          -  History of head surgery.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>April 22, 2020</study_first_submitted>
  <study_first_submitted_qc>June 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>June 8, 2020</last_update_submitted>
  <last_update_submitted_qc>June 8, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>SMG-SNU Boramae Medical Center</investigator_affiliation>
    <investigator_full_name>Jin-Young Hwang</investigator_full_name>
    <investigator_title>Associate professor</investigator_title>
  </responsible_party>
  <!-- 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/NCT04427085
org study id: 20421
nct id: NCT04427085
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This study aims to compare the change of optic nerve sheath diameter in obese and non-obese
      patients undergoing laparoscopic gynecological surgery in a steep Trendelenburg position.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Optic nerve sheath diameter
time frame: 30 minutes after pneuroperitoneum in the Trendelenburg position
description: Using ultrasonography, optic nerve sheath diameter is measured.
measure: Optic nerve sheath diameter
time frame: 15 minutes after pneuroperitoneum in the Trendelenburg position
description: Using ultrasonography, optic nerve sheath diameter is measured.
measure: Optic nerve sheath diameter
time frame: 60 minutes after pneuroperitoneum in the Trendelenburg position
description: Using ultrasonography, optic nerve sheath diameter is measured.
measure: Optic nerve sheath diameter
time frame: 10 minutes after release of pneumoperitoneum and return to the supine position
description: Using ultrasonography, optic nerve sheath diameter is measured.
measure: Optic nerve sheath diameter
time frame: At 1 hour after completion of surgery
description: Using ultrasonography, optic nerve sheath diameter is measured.
measure: Optic nerve sheath diameter
time frame: At 24 hours after completion of surgery
description: Using ultrasonography, optic nerve sheath diameter is measured.
measure: Nausea and vomiting
time frame: At 24 hours after completion of surgery
description: The presence and severity of nausea and vomiting is evaluated.
measure: Headache
time frame: At 24 hours after completion of surgery
description: The presence and severity of headache is evaluated.
arm group label: Obese group
arm group type: Experimental
description: body mass index≥ 30 kg/m2
arm group label: Non-obese group
arm group type: Active Comparator
description: BMI < 30 kg/m2
intervention type: Other
intervention name: Ultrasound assessment of optic nerve sheath diameter
description: Using ultrasonography, optic nerve sheath diameter is measured during perioperative period.
arm group label: Non-obese group
arm group label: Obese group
criteria: 
gender: Female
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: SMG-SNU Boramae Medical Center
investigator full name: Jin-Young Hwang
investigator title: Associate professor