<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/NCT03271502</url>
  </required_header>
  <id_info>
    <org_study_id>2017-1011</org_study_id>
    <nct_id>NCT03271502</nct_id>
  </id_info>
  <brief_title>Effect of Anesthesia on Optic Nerve Sheath Diameter in Patients Undergoing Robot-assisted Laparoscopic Prostatectomy</brief_title>
  <official_title>Effect of Inhalation Anesthesia With Sevoflurane and Total Intravenous Anesthesia With Propofol on Optic Nerve Sheath Diameter in Patients Undergoing Robot-assisted Laparoscopic Prostatectomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Asan Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Asan Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</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>
      The purpose of this study was to evaluate the difference between the optic nerve sheath&#xD;
      diameter measured during total intravenous anesthesia and the optic nerve sheath diameter&#xD;
      measured during inhalation anesthesia in patients undergoing robot-assisted laparoscopic&#xD;
      prostatectomy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study was to evaluate the difference between the optic nerve sheath&#xD;
      diameter measured during total intravenous anesthesia with propofol and remifentanil and the&#xD;
      optic nerve sheath diameter measured during inhalation anesthesia with sevoflurane and&#xD;
      remifentanil in patients undergoing robot-assisted laparoscopic prostatectomy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 4, 2017</start_date>
  <completion_date type="Actual">October 1, 2017</completion_date>
  <primary_completion_date type="Actual">September 26, 2017</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>
    <primary_purpose>Other</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Difference in optic nerve sheath diameter</measure>
    <time_frame>60 minutes after pneumoperitoneum and steep Trendelenburg position</time_frame>
    <description>Difference between the optic nerve sheath diameter measured during total intravenous anesthesia and the optic nerve sheath diameter measured during inhalation anesthesia</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Difference in optic nerve sheath diameter</measure>
    <time_frame>30 minutes after pneumoperitoneum and steep Trendelenburg position</time_frame>
    <description>Difference between the optic nerve sheath diameter measured during total intravenous anesthesia and the optic nerve sheath diameter measured during inhalation anesthesia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in optic nerve sheath diameter</measure>
    <time_frame>5 minutes after pneumoperitoneum and steep Trendelenburg position</time_frame>
    <description>Difference between the optic nerve sheath diameter measured during total intravenous anesthesia and the optic nerve sheath diameter measured during inhalation anesthesia</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">36</enrollment>
  <condition>Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>Total intravenous anesthesia</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Total intravenous anesthesia with propofol and remifentanil</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Inhalation anesthesia</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Inhalation anesthesia with sevoflurane and remifentanil</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Total intravenous anesthesia</intervention_name>
    <description>Total intravenous anesthesia with propofol and remifentanil</description>
    <arm_group_label>Total intravenous anesthesia</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Inhalation anesthesia</intervention_name>
    <description>Inhalation anesthesia with sevoflurane and remifentanil</description>
    <arm_group_label>Inhalation anesthesia</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients who have undergone a robot-assisted laparoscopic prostatectomy with a prostate&#xD;
        cancer and who are 20 years of age or older and under 80 years of age and who agree to&#xD;
        participate in this study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patients with a history of cerebral hemorrhage or cerebral infarction, Patients &lt; 20 years&#xD;
        of age, Patients ≥ 80 years of age, Patients with unexpected hemodynamic instability during&#xD;
        surgery, Failure to measure optic nerve sheath diameter.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>79 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Young-Kug Kim, MD,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Asan Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Asan Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>05505</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>August 31, 2017</study_first_submitted>
  <study_first_submitted_qc>August 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 5, 2017</study_first_posted>
  <last_update_submitted>October 25, 2017</last_update_submitted>
  <last_update_submitted_qc>October 25, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 26, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Asan Medical Center</investigator_affiliation>
    <investigator_full_name>Young-Kug Kim</investigator_full_name>
    <investigator_title>MD, PhD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anesthetics</mesh_term>
  </intervention_browse>
  <!-- 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/NCT03271502
org study id: 2017-1011
nct id: NCT03271502
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this study was to evaluate the difference between the optic nerve sheath
      diameter measured during total intravenous anesthesia and the optic nerve sheath diameter
      measured during inhalation anesthesia in patients undergoing robot-assisted laparoscopic
      prostatectomy.
The purpose of this study was to evaluate the difference between the optic nerve sheath
      diameter measured during total intravenous anesthesia with propofol and remifentanil and the
      optic nerve sheath diameter measured during inhalation anesthesia with sevoflurane and
      remifentanil in patients undergoing robot-assisted laparoscopic prostatectomy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Difference in optic nerve sheath diameter
time frame: 60 minutes after pneumoperitoneum and steep Trendelenburg position
description: Difference between the optic nerve sheath diameter measured during total intravenous anesthesia and the optic nerve sheath diameter measured during inhalation anesthesia
measure: Difference in optic nerve sheath diameter
time frame: 30 minutes after pneumoperitoneum and steep Trendelenburg position
description: Difference between the optic nerve sheath diameter measured during total intravenous anesthesia and the optic nerve sheath diameter measured during inhalation anesthesia
measure: Difference in optic nerve sheath diameter
time frame: 5 minutes after pneumoperitoneum and steep Trendelenburg position
description: Difference between the optic nerve sheath diameter measured during total intravenous anesthesia and the optic nerve sheath diameter measured during inhalation anesthesia
arm group label: Total intravenous anesthesia
arm group type: Experimental
description: Total intravenous anesthesia with propofol and remifentanil
arm group label: Inhalation anesthesia
arm group type: Active Comparator
description: Inhalation anesthesia with sevoflurane and remifentanil
intervention type: Procedure
intervention name: Total intravenous anesthesia
description: Total intravenous anesthesia with propofol and remifentanil
arm group label: Total intravenous anesthesia
intervention type: Procedure
intervention name: Inhalation anesthesia
description: Inhalation anesthesia with sevoflurane and remifentanil
arm group label: Inhalation anesthesia
criteria: 
gender: Male
minimum age: 20 Years
maximum age: 79 Years
healthy volunteers: No
last name: Young-Kug Kim, MD,PhD
role: Principal Investigator
affiliation: Asan Medical Center
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Asan Medical Center
investigator full name: Young-Kug Kim
investigator title: MD, PhD
mesh term: Prostatic Neoplasms
mesh term: Anesthetics