<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/NCT01669135</url>
  </required_header>
  <id_info>
    <org_study_id>M19-12-21-2010</org_study_id>
    <nct_id>NCT01669135</nct_id>
  </id_info>
  <brief_title>Spinal Anesthesia for Cesarean Delivery is Associated With Decreases in Regional Cerebral Oxygen Saturation as Assessed by Near- Infrared Spectroscopy</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Athens</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Athens</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The cerebral oxygen saturation is assessed by means of near-infrared spectometry in&#xD;
      parturients undergoing cesarean delivery under spinal anesthesia. The investigators&#xD;
      hypothesis was that spinal anesthesia does not influence cerebral oxygen saturation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>December 2010</start_date>
  <completion_date type="Actual">August 2012</completion_date>
  <primary_completion_date type="Actual">May 2012</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>cerebral oxygen saturation of the right frontal lobe</measure>
    <time_frame>Change from the performing of spinal anesthesia untill 1 minute after delivery</time_frame>
    <description>Cerebral oxygen saturation is important as it may affect patient's outcome</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>cerebral oxygen saturation of the left frontal lobe</measure>
    <time_frame>5, 10, 50 min after spinal,1 minute after delivery</time_frame>
    <description>Cerebral oxygen saturation is important for patient's outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Thigh oxygen saturation</measure>
    <time_frame>5, 10, 50 min after spinal, 1 minute after delivery</time_frame>
    <description>Thigh oxygen saturation may reflect blood redistribution due to spinal block</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Arterial Oxygenation</measure>
    <time_frame>5, 10, 50 min after spinal, 1 minute after delivery</time_frame>
    <description>Changes in arterial oxygenation may reflect blood redistribution due to spinal block</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Hemodynamic changes (Changes in Blood Pressure (mmHg) and Heart rate (beats/min)</measure>
    <time_frame>5, 10, 50 min after spinal, 1 minute after delivery</time_frame>
    <description>Hemodynamic changes (changes in Blood Pressure and Heart rate) may reflect blood redistribution due to spinal block</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">34</enrollment>
  <condition>Cerebral Oxygen Saturation During Spinal Anesthesia for Cesarean Delivery</condition>
  <arm_group>
    <arm_group_label>Spinal Anesthesia with cerebral oxygen saturation monitoring</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The cerebral oxygen saturation of the right and left frontal lobe as well as the thigh oxygen saturation are monitored during spinal anesthesia by means of the near-infrared spectroscopy. Hemodynamic variables were recorded at the same time points.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Spinal Anesthesia with cerebral oxygen saturation monitoring</intervention_name>
    <arm_group_label>Spinal Anesthesia with cerebral oxygen saturation monitoring</arm_group_label>
    <other_name>INVOS (cerebral oximeter model 5100, Somanetics, Troy, MI, USA)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Term healthy parturients&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Body Mass Index &gt; 35&#xD;
&#xD;
          -  preeclampsia&#xD;
&#xD;
          -  neurological,cardiovascular, respiratory disease&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>48 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Department of Anesthesiology, Aretaieio Hospital</name>
      <address>
        <city>Athens</city>
        <zip>11528</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Greece</country>
  </location_countries>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 8, 2012</study_first_submitted>
  <study_first_submitted_qc>August 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 20, 2012</study_first_posted>
  <last_update_submitted>August 17, 2012</last_update_submitted>
  <last_update_submitted_qc>August 17, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 20, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Athens</investigator_affiliation>
    <investigator_full_name>Argyro Fassoulaki</investigator_full_name>
    <investigator_title>MD, PhD, DEAA</investigator_title>
  </responsible_party>
  <keyword>cerebral oximetry</keyword>
  <keyword>cesarean delivery</keyword>
  <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/NCT01669135
org study id: M19-12-21-2010
nct id: NCT01669135
lead sponsor: 
has dmc: No
The cerebral oxygen saturation is assessed by means of near-infrared spectometry in
      parturients undergoing cesarean delivery under spinal anesthesia. The investigators
      hypothesis was that spinal anesthesia does not influence cerebral oxygen saturation.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: cerebral oxygen saturation of the right frontal lobe
time frame: Change from the performing of spinal anesthesia untill 1 minute after delivery
description: Cerebral oxygen saturation is important as it may affect patient's outcome
measure: cerebral oxygen saturation of the left frontal lobe
time frame: 5, 10, 50 min after spinal,1 minute after delivery
description: Cerebral oxygen saturation is important for patient's outcome
measure: Thigh oxygen saturation
time frame: 5, 10, 50 min after spinal, 1 minute after delivery
description: Thigh oxygen saturation may reflect blood redistribution due to spinal block
measure: Arterial Oxygenation
time frame: 5, 10, 50 min after spinal, 1 minute after delivery
description: Changes in arterial oxygenation may reflect blood redistribution due to spinal block
measure: Hemodynamic changes (Changes in Blood Pressure (mmHg) and Heart rate (beats/min)
time frame: 5, 10, 50 min after spinal, 1 minute after delivery
description: Hemodynamic changes (changes in Blood Pressure and Heart rate) may reflect blood redistribution due to spinal block
arm group label: Spinal Anesthesia with cerebral oxygen saturation monitoring
arm group type: Other
description: The cerebral oxygen saturation of the right and left frontal lobe as well as the thigh oxygen saturation are monitored during spinal anesthesia by means of the near-infrared spectroscopy. Hemodynamic variables were recorded at the same time points.
intervention type: Other
intervention name: Spinal Anesthesia with cerebral oxygen saturation monitoring
arm group label: Spinal Anesthesia with cerebral oxygen saturation monitoring
other name: INVOS (cerebral oximeter model 5100, Somanetics, Troy, MI, USA)
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 48 Years
healthy volunteers: No
facility: 
country: Greece
responsible party type: Principal Investigator
investigator affiliation: University of Athens
investigator full name: Argyro Fassoulaki
investigator title: MD, PhD, DEAA
mesh term: Anesthetics