<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/NCT02253381</url>
  </required_header>
  <id_info>
    <org_study_id>REC: 57-195-08-1</org_study_id>
    <nct_id>NCT02253381</nct_id>
  </id_info>
  <brief_title>Effect of Position During Spinal Anesthesia on Hemodynamic Change in Cesarean Section</brief_title>
  <official_title>Effect of Position During Spinal Anesthesia on Hemodynamic Change in Pregnant Women Undergoing Cesarean Section: Randomized Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Prince of Songkla University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Prince of Songkla University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Hypotension is the most common complications after spinal anesthesia especially in pregnant&#xD;
      patients who undergoing cesarean section. Position during spinal anesthesia may be altering&#xD;
      the hemodynamic. For right lateral decubitus, the enlarged uterus compresses inferior vena&#xD;
      cava that may decrease venous return and cardiac output. This leads to hypotension.The&#xD;
      hypothesis is the right lateral position during spinal anesthesia in pregnant women will be&#xD;
      had hemodynamic changing more than the left lateral position. This objective is to compare&#xD;
      hemodynamic change between left and right lateral position during spinal anesthesia in&#xD;
      pregnant women undergoing cesarean section.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study design: A randomized controlled trial&#xD;
&#xD;
      Study setting:&#xD;
&#xD;
      The study will be conducted in the operating rooms at Songklanagarind Hospital, Faculty of&#xD;
      Medicine, Prince of Songkla University, Songkhla, Thailand&#xD;
&#xD;
      Study period:&#xD;
&#xD;
      The total duration of participation in the randomized study is up to the operative day.&#xD;
&#xD;
      Study population:&#xD;
&#xD;
      Pregnant patients undergoing cesarean section receiving spinal anesthesia with 0.5%&#xD;
      bupivacaine and 0.2 mg morphine total volume 2.2 ml.&#xD;
&#xD;
      Study sample:&#xD;
&#xD;
      Inclusion criteria&#xD;
&#xD;
        1. Signed informed consent&#xD;
&#xD;
        2. Pregnancy&#xD;
&#xD;
        3. Spinal anesthesia with 0.5% bupivacaine and 0.2 mg morphine total volume 2.2 ml&#xD;
&#xD;
        4. Elective and emergency surgery&#xD;
&#xD;
      Exclusion criteria&#xD;
&#xD;
        1. Contraindication for spinal anesthesia&#xD;
&#xD;
        2. Complicated pregnancy such as maternal heart disease, eclampsia, severe fetal distress,&#xD;
           abruption placenta, twin pregnancy, and placenta previa totalis&#xD;
&#xD;
        3. Maternal height &lt; 150 cm.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">March 2015</completion_date>
  <primary_completion_date type="Actual">March 2015</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Hypotension</measure>
    <time_frame>after bupivacaine injection until 15 minutes after spinal anesthesia</time_frame>
    <description>Systolic blood pressure lower than 90 mmHg or decrease more than 20% of baseline</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Ephedrine consumption</measure>
    <time_frame>intraoperative</time_frame>
    <description>Total amount of ephedrine receiving</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apgar score at first minute and fifth minute</measure>
    <time_frame>Child delivery at first minute and fifth minute</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">140</enrollment>
  <condition>Hypotension</condition>
  <arm_group>
    <arm_group_label>Right lateral decubitus position</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Right lateral decubitus position during spinal anesthesia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Left lateral decubitus position</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Left lateral decubitus position during spinal anesthesia</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Right</intervention_name>
    <description>Right lateral decubitus position during spinal anesthesia</description>
    <arm_group_label>Right lateral decubitus position</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Left</intervention_name>
    <description>Left lateral decubitus position during spinal anesthesia</description>
    <arm_group_label>Left lateral decubitus position</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Signed informed consent&#xD;
&#xD;
          -  Term pregnancy&#xD;
&#xD;
          -  Spinal anesthesia with 0.5% bupivacaine and 0.2 mg morphine total volume 2.2 ml&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contraindication for spinal anesthesia&#xD;
&#xD;
          -  Height &lt; 150 cm.&#xD;
&#xD;
          -  Complicated pregnancy e.g. heart disease, preclampsia, eclampsia, diabetes millitus,&#xD;
             twin, abrupt placenta, placenta pre via, and fetal distress&#xD;
&#xD;
          -  Failed spinal anesthesia&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Boonsin Tangtrakulwanish, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Ethical Committee</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of anesthesiology, Faculty of Medicine, Prince of Songkla University</name>
      <address>
        <city>Hat Yai</city>
        <state>Songkhla</state>
        <zip>90110</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Thailand</country>
  </location_countries>
  <verification_date>April 2015</verification_date>
  <study_first_submitted>September 27, 2014</study_first_submitted>
  <study_first_submitted_qc>September 30, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 1, 2014</study_first_posted>
  <last_update_submitted>April 27, 2015</last_update_submitted>
  <last_update_submitted_qc>April 27, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 29, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Prince of Songkla University</investigator_affiliation>
    <investigator_full_name>Panthila Rujirojindakul</investigator_full_name>
    <investigator_title>Dr</investigator_title>
  </responsible_party>
  <keyword>lateral decubitus position</keyword>
  <keyword>hypotension</keyword>
  <keyword>cesarean section</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypotension</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/NCT02253381
org study id: REC: 57-195-08-1
nct id: NCT02253381
lead sponsor: 
has dmc: Yes
Hypotension is the most common complications after spinal anesthesia especially in pregnant
      patients who undergoing cesarean section. Position during spinal anesthesia may be altering
      the hemodynamic. For right lateral decubitus, the enlarged uterus compresses inferior vena
      cava that may decrease venous return and cardiac output. This leads to hypotension.The
      hypothesis is the right lateral position during spinal anesthesia in pregnant women will be
      had hemodynamic changing more than the left lateral position. This objective is to compare
      hemodynamic change between left and right lateral position during spinal anesthesia in
      pregnant women undergoing cesarean section.
Study design: A randomized controlled trial

      Study setting:

      The study will be conducted in the operating rooms at Songklanagarind Hospital, Faculty of
      Medicine, Prince of Songkla University, Songkhla, Thailand

      Study period:

      The total duration of participation in the randomized study is up to the operative day.

      Study population:

      Pregnant patients undergoing cesarean section receiving spinal anesthesia with 0.5%
      bupivacaine and 0.2 mg morphine total volume 2.2 ml.

      Study sample:

      Inclusion criteria

        1. Signed informed consent

        2. Pregnancy

        3. Spinal anesthesia with 0.5% bupivacaine and 0.2 mg morphine total volume 2.2 ml

        4. Elective and emergency surgery

      Exclusion criteria

        1. Contraindication for spinal anesthesia

        2. Complicated pregnancy such as maternal heart disease, eclampsia, severe fetal distress,
           abruption placenta, twin pregnancy, and placenta previa totalis

        3. Maternal height < 150 cm.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: Hypotension
time frame: after bupivacaine injection until 15 minutes after spinal anesthesia
description: Systolic blood pressure lower than 90 mmHg or decrease more than 20% of baseline
measure: Ephedrine consumption
time frame: intraoperative
description: Total amount of ephedrine receiving
measure: Apgar score at first minute and fifth minute
time frame: Child delivery at first minute and fifth minute
arm group label: Right lateral decubitus position
arm group type: Active Comparator
description: Right lateral decubitus position during spinal anesthesia
arm group label: Left lateral decubitus position
arm group type: Active Comparator
description: Left lateral decubitus position during spinal anesthesia
intervention type: Procedure
intervention name: Right
description: Right lateral decubitus position during spinal anesthesia
arm group label: Right lateral decubitus position
intervention type: Procedure
intervention name: Left
description: Left lateral decubitus position during spinal anesthesia
arm group label: Left lateral decubitus position
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Boonsin Tangtrakulwanish, MD
role: Study Chair
affiliation: Ethical Committee
facility: 
country: Thailand
responsible party type: Principal Investigator
investigator affiliation: Prince of Songkla University
investigator full name: Panthila Rujirojindakul
investigator title: Dr
mesh term: Hypotension