<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/NCT04446013</url>
  </required_header>
  <id_info>
    <org_study_id>2020.05.1.16.048</org_study_id>
    <nct_id>NCT04446013</nct_id>
  </id_info>
  <brief_title>Comparison of ONSD and rSO2 Measurements Between General and Spinal Anesthesia in C-Section</brief_title>
  <official_title>Comparison of Optic Nerve Sheath Diameter and Cerebral Regional Oxygen Saturation Measurements Between General and Spinal Anesthesia Applications in C-Section</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bagcilar Training and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bagcilar Training and Research Hospital</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>
      General anesthesia and regional anesthesia can be chosen in cesarean operations. Endotracheal&#xD;
      intubation and mechanical ventilation are components of general anesthesia. Endotracheal&#xD;
      intubation has been shown to cause increased intracranial pressure. There is not enough&#xD;
      information about the effect of spinal anesthesia on intracranial pressure during cesarean&#xD;
      operations. Increased intracranial pressure can cause neurological complications by&#xD;
      disrupting brain perfusion. For this reason, the investigators think that the safe anesthesia&#xD;
      method should be determined especially in pregnant patients who are at risk of increased&#xD;
      intracranial pressure.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 15, 2020</start_date>
  <completion_date type="Actual">July 30, 2020</completion_date>
  <primary_completion_date type="Actual">June 25, 2020</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>Prevention</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Optic Nerve Sheath Diameter</measure>
    <time_frame>Throughout the surgery</time_frame>
    <description>The change in intracranial pressure via optic nerve sheath diameter measurement during c-section among 5 time point.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in regional cerebral oxygen saturation</measure>
    <time_frame>Throughout the surgery</time_frame>
    <description>The change in regional cerebral oxygen saturation during c-section among 5 time point.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Perioperative Hemodynamic Parameters</measure>
    <time_frame>Throughout the surgery</time_frame>
    <description>Mean arterial pressure in mmHg</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perioperative Hemodynamic Parameters</measure>
    <time_frame>Throughout the surgery</time_frame>
    <description>Heart rate beat per minute</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">81</enrollment>
  <condition>Intracranial Pressure Increase</condition>
  <arm_group>
    <arm_group_label>Group General Anesthesia</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>C-Section under general anesthesia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Grup Spinal Anesthesia</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>C-Section under spinal anesthesia</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Optic Nerve Sheath Diameter Measurement</intervention_name>
    <description>The change in intracranial pressure via optic nerve sheath diameter measurement</description>
    <arm_group_label>Group General Anesthesia</arm_group_label>
    <arm_group_label>Grup Spinal Anesthesia</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Undergoing elective c-section operation&#xD;
&#xD;
          -  Age between 18-49&#xD;
&#xD;
          -  ASA I-II&#xD;
&#xD;
          -  Gestational week ≥ 36&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Ophthalmologic disease and optic nerve pathology&#xD;
&#xD;
          -  Increased intracranial pressure&#xD;
&#xD;
          -  History of cerebrovascular disease&#xD;
&#xD;
          -  Cases where spinal anesthesia is contraindicated&#xD;
&#xD;
          -  Emergency cesarean category level 1&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Pregnant and undergoing c-section operation</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>49 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mehmet Can Tunalı</last_name>
    <role>Principal Investigator</role>
    <affiliation>Bagcilar Training and Research Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Bagcilar Training and Research Hospital</name>
      <address>
        <city>Istanbul</city>
        <zip>34200</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <reference>
    <citation>Geeraerts T, Merceron S, Benhamou D, Vigue B, Duranteau J. Non-invasive assessment of intracranial pressure using ocular sonography in neurocritical care patients. Intensive Care Med. 2008 Nov;34(11):2062-7. doi: 10.1007/s00134-008-1149-x. Epub 2008 May 29.</citation>
    <PMID>18509619</PMID>
  </reference>
  <reference>
    <citation>Bauerle J, Nedelmann M. Sonographic assessment of the optic nerve sheath in idiopathic intracranial hypertension. J Neurol. 2011 Nov;258(11):2014-9. doi: 10.1007/s00415-011-6059-0. Epub 2011 Apr 28.</citation>
    <PMID>21523461</PMID>
  </reference>
  <reference>
    <citation>Yoshitani K, Kawaguchi M, Miura N, Okuno T, Kanoda T, Ohnishi Y, Kuro M. Effects of hemoglobin concentration, skull thickness, and the area of the cerebrospinal fluid layer on near-infrared spectroscopy measurements. Anesthesiology. 2007 Mar;106(3):458-62. doi: 10.1097/00000542-200703000-00009.</citation>
    <PMID>17325503</PMID>
  </reference>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>June 22, 2020</study_first_submitted>
  <study_first_submitted_qc>June 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 24, 2020</study_first_posted>
  <last_update_submitted>September 4, 2020</last_update_submitted>
  <last_update_submitted_qc>September 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>optic nerve sheath diameter</keyword>
  <keyword>intracranial pressure</keyword>
  <keyword>intraabdominal pressure</keyword>
  <keyword>cerebral regional oxygen saturation</keyword>
  <keyword>c-section</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Intracranial Hypertension</mesh_term>
  </condition_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/NCT04446013
org study id: 2020.05.1.16.048
nct id: NCT04446013
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
General anesthesia and regional anesthesia can be chosen in cesarean operations. Endotracheal
      intubation and mechanical ventilation are components of general anesthesia. Endotracheal
      intubation has been shown to cause increased intracranial pressure. There is not enough
      information about the effect of spinal anesthesia on intracranial pressure during cesarean
      operations. Increased intracranial pressure can cause neurological complications by
      disrupting brain perfusion. For this reason, the investigators think that the safe anesthesia
      method should be determined especially in pregnant patients who are at risk of increased
      intracranial pressure.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: Change in Optic Nerve Sheath Diameter
time frame: Throughout the surgery
description: The change in intracranial pressure via optic nerve sheath diameter measurement during c-section among 5 time point.
measure: Change in regional cerebral oxygen saturation
time frame: Throughout the surgery
description: The change in regional cerebral oxygen saturation during c-section among 5 time point.
measure: Perioperative Hemodynamic Parameters
time frame: Throughout the surgery
description: Mean arterial pressure in mmHg
measure: Perioperative Hemodynamic Parameters
time frame: Throughout the surgery
description: Heart rate beat per minute
arm group label: Group General Anesthesia
arm group type: Experimental
description: C-Section under general anesthesia
arm group label: Grup Spinal Anesthesia
arm group type: Experimental
description: C-Section under spinal anesthesia
intervention type: Other
intervention name: Optic Nerve Sheath Diameter Measurement
description: The change in intracranial pressure via optic nerve sheath diameter measurement
arm group label: Group General Anesthesia
arm group label: Grup Spinal Anesthesia
criteria: 
gender: Female
gender based: Yes
gender description: Pregnant and undergoing c-section operation
minimum age: 18 Years
maximum age: 49 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Mehmet Can Tunalı
role: Principal Investigator
affiliation: Bagcilar Training and Research Hospital
facility: 
country: Turkey
citation: Geeraerts T, Merceron S, Benhamou D, Vigue B, Duranteau J. Non-invasive assessment of intracranial pressure using ocular sonography in neurocritical care patients. Intensive Care Med. 2008 Nov;34(11):2062-7. doi: 10.1007/s00134-008-1149-x. Epub 2008 May 29.
PMID: 18509619
citation: Bauerle J, Nedelmann M. Sonographic assessment of the optic nerve sheath in idiopathic intracranial hypertension. J Neurol. 2011 Nov;258(11):2014-9. doi: 10.1007/s00415-011-6059-0. Epub 2011 Apr 28.
PMID: 21523461
citation: Yoshitani K, Kawaguchi M, Miura N, Okuno T, Kanoda T, Ohnishi Y, Kuro M. Effects of hemoglobin concentration, skull thickness, and the area of the cerebrospinal fluid layer on near-infrared spectroscopy measurements. Anesthesiology. 2007 Mar;106(3):458-62. doi: 10.1097/00000542-200703000-00009.
PMID: 17325503
responsible party type: Sponsor
mesh term: Intracranial Hypertension