<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/NCT02194192</url>
  </required_header>
  <id_info>
    <org_study_id>810/2556(EC2)</org_study_id>
    <secondary_id>(IO)R015731034</secondary_id>
    <nct_id>NCT02194192</nct_id>
  </id_info>
  <brief_title>Prophylaxis Ephedrine or Ondansetron Prevents Hypotension After Spinal Anesthesia for Cesarean Section</brief_title>
  <official_title>Prophylaxis Ephedrine or Ondansetron Prevents Hypotension After Spinal Anesthesia for Cesarean Section; a Randomized, Double Blinded, Placebo Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mahidol University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mahidol University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Maternal hypotension after spinal anesthesia in parturients undergoing cesarean section is a&#xD;
      very common problem leading to several complications to both patients and their babies. It&#xD;
      can cause maternal discomfort, lightheadedness, nausea and vomiting. The most important&#xD;
      complication is the decreasing blood flow to babies; which may lead to fetal acidosis.&#xD;
&#xD;
      Many interventions has been studied in order to prevent hypotension after spinal anesthesia&#xD;
      in cesarean section e.g., fluid loading: colloid vs crystalloid, medications: ephedrine,&#xD;
      phenylephrine, and metaraminol, etc. The recent study showed ondansetron (the antiemetic&#xD;
      drug) can be effectively used to prevent hypotension after spinal anesthesia in normal&#xD;
      patients or parturients. The action of ondansetron is believed to inhibit Bezold-Jarish&#xD;
      reflex.&#xD;
&#xD;
      This aim of this study is to compare the efficacy of ephedrine and ondansetron in the&#xD;
      prevention of maternal hypotension after spinal anesthesia in cesarean section.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 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>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Comparing efficacy of ondansetron to ephedrine in the prevention of hypotension.</measure>
    <time_frame>After spinal block to until baby delivered</time_frame>
    <description>Ondansetron or ephedrine will be given immediately after spinal anesthesia, then record blood pressure and heart rate one-minutely until delivery.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Maternal symptom: Nausea and vomiting after spinal anesthesia</measure>
    <time_frame>After spinal anesthesia until baby delivered</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Apgar score</measure>
    <time_frame>one minute and five minute after delivery</time_frame>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">168</enrollment>
  <condition>Anesthesia; Adverse Effect, Spinal and Epidural</condition>
  <arm_group>
    <arm_group_label>Group E</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Ephedrine 10 mg in Normal Saline 10 ml</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group O</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Ondansetron 8 mg in Normal saline 10 ml</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group P</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Normal saline 10 ml</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Normal saline 10 ml</description>
    <arm_group_label>Group P</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ondansetron</intervention_name>
    <description>Ondasetron 8 mg IV after spinal anesthesia</description>
    <arm_group_label>Group O</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ephedrine</intervention_name>
    <description>Ephedrine 10 mg IV after spinal anesthesia</description>
    <arm_group_label>Group E</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt; 18 years&#xD;
&#xD;
          -  Elective cesarean section&#xD;
&#xD;
          -  Patient accept spinal anesthesia&#xD;
&#xD;
          -  ASA classification I-II&#xD;
&#xD;
          -  Term, Singleton pregnancy&#xD;
&#xD;
          -  Understand all process in this study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  DM any type that not the gestational DM&#xD;
&#xD;
          -  Hypertensive disorder&#xD;
&#xD;
          -  BMI&gt;40&#xD;
&#xD;
          -  Complicated pregnancy such as placenta previa, preeclampsia&#xD;
&#xD;
          -  Allergic to study drugs&#xD;
&#xD;
          -  Long QT syndrome&#xD;
&#xD;
          -  Contraindication to spinal anesthesia&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Patchareya Nivatpumin, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Anesthesiology, Faculty of Medicine Siriraj Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Siriraj Hospital, Mahidol University</name>
      <address>
        <city>Bangkok</city>
        <zip>10700</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Thailand</country>
  </location_countries>
  <reference>
    <citation>Sahoo T, SenDasgupta C, Goswami A, Hazra A. Reduction in spinal-induced hypotension with ondansetron in parturients undergoing caesarean section: a double-blind randomised, placebo-controlled study. Int J Obstet Anesth. 2012 Jan;21(1):24-8. doi: 10.1016/j.ijoa.2011.08.002. Epub 2011 Nov 18.</citation>
    <PMID>22100822</PMID>
  </reference>
  <reference>
    <citation>Owczuk R, Wenski W, Polak-Krzeminska A, Twardowski P, Arszulowicz R, Dylczyk-Sommer A, Wujtewicz MA, Sawicka W, Morzuch E, Smietanski M, Wujtewicz M. Ondansetron given intravenously attenuates arterial blood pressure drop due to spinal anesthesia: a double-blind, placebo-controlled study. Reg Anesth Pain Med. 2008 Jul-Aug;33(4):332-9. doi: 10.1016/j.rapm.2008.01.010.</citation>
    <PMID>18675744</PMID>
  </reference>
  <reference>
    <citation>Lee A, Ngan Kee WD, Gin T. Prophylactic ephedrine prevents hypotension during spinal anesthesia for Cesarean delivery but does not improve neonatal outcome: a quantitative systematic review. Can J Anaesth. 2002 Jun-Jul;49(6):588-99. doi: 10.1007/BF03017387.</citation>
    <PMID>12067872</PMID>
  </reference>
  <reference>
    <citation>Cyna AM, Andrew M, Emmett RS, Middleton P, Simmons SW. Techniques for preventing hypotension during spinal anaesthesia for caesarean section. Cochrane Database Syst Rev. 2006 Oct 18;(4):CD002251. doi: 10.1002/14651858.CD002251.pub2.</citation>
    <PMID>17054153</PMID>
  </reference>
  <reference>
    <citation>Lee A, Ngan Kee WD, Gin T. A dose-response meta-analysis of prophylactic intravenous ephedrine for the prevention of hypotension during spinal anesthesia for elective cesarean delivery. Anesth Analg. 2004 Feb;98(2):483-490. doi: 10.1213/01.ANE.0000096183.49619.FC. Erratum In: Anesth Analg. 2004 Apr;98(4):955.</citation>
    <PMID>14742392</PMID>
  </reference>
  <verification_date>March 2015</verification_date>
  <study_first_submitted>July 16, 2014</study_first_submitted>
  <study_first_submitted_qc>July 17, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 18, 2014</study_first_posted>
  <last_update_submitted>March 13, 2015</last_update_submitted>
  <last_update_submitted_qc>March 13, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 17, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>prevention of hypotension</keyword>
  <keyword>spinal anesthesia</keyword>
  <keyword>cesarean section</keyword>
  <keyword>ephedrine</keyword>
  <keyword>ondansetron</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypotension</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ephedrine</mesh_term>
    <mesh_term>Ondansetron</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/NCT02194192
org study id: 810/2556(EC2)
secondary id: (IO)R015731034
nct id: NCT02194192
lead sponsor: 
has dmc: Yes
Maternal hypotension after spinal anesthesia in parturients undergoing cesarean section is a
      very common problem leading to several complications to both patients and their babies. It
      can cause maternal discomfort, lightheadedness, nausea and vomiting. The most important
      complication is the decreasing blood flow to babies; which may lead to fetal acidosis.

      Many interventions has been studied in order to prevent hypotension after spinal anesthesia
      in cesarean section e.g., fluid loading: colloid vs crystalloid, medications: ephedrine,
      phenylephrine, and metaraminol, etc. The recent study showed ondansetron (the antiemetic
      drug) can be effectively used to prevent hypotension after spinal anesthesia in normal
      patients or parturients. The action of ondansetron is believed to inhibit Bezold-Jarish
      reflex.

      This aim of this study is to compare the efficacy of ephedrine and ondansetron in the
      prevention of maternal hypotension after spinal anesthesia in cesarean section.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Prevention
masking: Triple (Participant, Care Provider, Investigator)
measure: Comparing efficacy of ondansetron to ephedrine in the prevention of hypotension.
time frame: After spinal block to until baby delivered
description: Ondansetron or ephedrine will be given immediately after spinal anesthesia, then record blood pressure and heart rate one-minutely until delivery.
measure: Maternal symptom: Nausea and vomiting after spinal anesthesia
time frame: After spinal anesthesia until baby delivered
measure: Apgar score
time frame: one minute and five minute after delivery
arm group label: Group E
arm group type: Experimental
description: Ephedrine 10 mg in Normal Saline 10 ml
arm group label: Group O
arm group type: Active Comparator
description: Ondansetron 8 mg in Normal saline 10 ml
arm group label: Group P
arm group type: Placebo Comparator
description: Normal saline 10 ml
intervention type: Drug
intervention name: Placebo
description: Normal saline 10 ml
arm group label: Group P
intervention type: Drug
intervention name: Ondansetron
description: Ondasetron 8 mg IV after spinal anesthesia
arm group label: Group O
intervention type: Drug
intervention name: Ephedrine
description: Ephedrine 10 mg IV after spinal anesthesia
arm group label: Group E
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Patchareya Nivatpumin, M.D.
role: Principal Investigator
affiliation: Department of Anesthesiology, Faculty of Medicine Siriraj Hospital
facility: 
country: Thailand
citation: Sahoo T, SenDasgupta C, Goswami A, Hazra A. Reduction in spinal-induced hypotension with ondansetron in parturients undergoing caesarean section: a double-blind randomised, placebo-controlled study. Int J Obstet Anesth. 2012 Jan;21(1):24-8. doi: 10.1016/j.ijoa.2011.08.002. Epub 2011 Nov 18.
PMID: 22100822
citation: Owczuk R, Wenski W, Polak-Krzeminska A, Twardowski P, Arszulowicz R, Dylczyk-Sommer A, Wujtewicz MA, Sawicka W, Morzuch E, Smietanski M, Wujtewicz M. Ondansetron given intravenously attenuates arterial blood pressure drop due to spinal anesthesia: a double-blind, placebo-controlled study. Reg Anesth Pain Med. 2008 Jul-Aug;33(4):332-9. doi: 10.1016/j.rapm.2008.01.010.
PMID: 18675744
citation: Lee A, Ngan Kee WD, Gin T. Prophylactic ephedrine prevents hypotension during spinal anesthesia for Cesarean delivery but does not improve neonatal outcome: a quantitative systematic review. Can J Anaesth. 2002 Jun-Jul;49(6):588-99. doi: 10.1007/BF03017387.
PMID: 12067872
citation: Cyna AM, Andrew M, Emmett RS, Middleton P, Simmons SW. Techniques for preventing hypotension during spinal anaesthesia for caesarean section. Cochrane Database Syst Rev. 2006 Oct 18;(4):CD002251. doi: 10.1002/14651858.CD002251.pub2.
PMID: 17054153
citation: Lee A, Ngan Kee WD, Gin T. A dose-response meta-analysis of prophylactic intravenous ephedrine for the prevention of hypotension during spinal anesthesia for elective cesarean delivery. Anesth Analg. 2004 Feb;98(2):483-490. doi: 10.1213/01.ANE.0000096183.49619.FC. Erratum In: Anesth Analg. 2004 Apr;98(4):955.
PMID: 14742392
responsible party type: Sponsor
mesh term: Hypotension
mesh term: Ephedrine
mesh term: Ondansetron