<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/NCT01669213</url>
  </required_header>
  <id_info>
    <org_study_id>WSAhn_ramosetron_hypotension</org_study_id>
    <nct_id>NCT01669213</nct_id>
  </id_info>
  <brief_title>Effects of Different Kinds, Different Doses of 5-HT3 Receptor Antagonists on Prevention of Hypotension</brief_title>
  <official_title>Effects of Different Kinds, Different Doses of 5-HT3 Receptor Antagonists on Prevention of Hypotension After Spinal Anesthesia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seoul National University Hospital</source>
  <brief_summary>
    <textblock>
      The purpose of this study is to estimate effects of different kinds, different dose of 5-HT3&#xD;
      receptor antagonists on prevention of hypotension after spinal anesthesia&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>August 2012</start_date>
  <completion_date type="Anticipated">August 2013</completion_date>
  <primary_completion_date type="Anticipated">December 2012</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>Factorial Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>prevention of hypotension by calcaulation the gap between baseline mean arterial pressure and lowest mean arterial pressure measured during 30 minutes after spinal anesthesia.</measure>
    <time_frame>up to 30mins after spinal anesthesia</time_frame>
    <description>comparasion of significantly difference in the gap between baseline mean arterial pressure and lowest mean arterial pressure measured during 30 minutes after spinal anesthesia.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>prevention of hypotension bycalculation the gap baseline systolic and diastolic blood pressure and lowerst systolic and diastolic blood pressure</measure>
    <time_frame>up to 30mins after spinal anesthesia</time_frame>
    <description>comparasion of significantly difference in the gap between baseline systolic arterial pressure and lowest systolic arterial pressure measured during 30 minutes after spinal anesthesia and the gap between baseline diastolic arterial pressure and lowest diastolic arterial pressure measured during 30 minutes after spinal anesthesia.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>occurrence ratio of shivering, nausea and vomiting, and usage doses of vasopressor (ephedrine or phenylephrine), and atropine</measure>
    <time_frame>up to 30 min after spinal anesthesia</time_frame>
  </other_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Hypotension</condition>
  <condition>Shivering</condition>
  <condition>Nausea and Vomiting</condition>
  <condition>Vasopressor</condition>
  <arm_group>
    <arm_group_label>ramosetron 0.3 mg</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>preparation of ramosetron 0.3 mg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ondansetron 8 mg</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>preparation of ondansetron 8mg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ondansetron 4 mg</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>preparation of ondansetron 4mg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>non 5-HT3 receptor antagonist</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>preparation of normal saline 5 ml</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ramosetron</intervention_name>
    <description>before 5 minutes spinal anesthesia, injection of ramosetron 0.3 mg</description>
    <arm_group_label>ramosetron 0.3 mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ondansetron</intervention_name>
    <description>before 5 minutes spinal anesthesia, injection of ondansetron 8 mg</description>
    <arm_group_label>ondansetron 8 mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ondansetron</intervention_name>
    <description>before 5 minutes spinal anesthesia, injection of ondansetron 4 mg</description>
    <arm_group_label>ondansetron 4 mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>placebo</intervention_name>
    <description>before 5 minutes spinal anesthesia, injection of normal saline 5 ml</description>
    <arm_group_label>non 5-HT3 receptor antagonist</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients undergoing spinal anesthesia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  hypersensitivity on 5-HT3 receptor antagonists hypertension cardiovascular disease&#xD;
             intake of selective serotonin reuptake inhibitor&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>110-744</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 10, 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>Seoul National University Hospital</investigator_affiliation>
    <investigator_full_name>Wonsik Ahn</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>5-HT3 receptor antagonist</keyword>
  <keyword>hypotension</keyword>
  <keyword>spinal anesthesia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypotension</mesh_term>
    <mesh_term>Vomiting</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ondansetron</mesh_term>
    <mesh_term>Ramosetron</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/NCT01669213
org study id: WSAhn_ramosetron_hypotension
nct id: NCT01669213
lead sponsor: 
The purpose of this study is to estimate effects of different kinds, different dose of 5-HT3
      receptor antagonists on prevention of hypotension after spinal anesthesia
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: prevention of hypotension by calcaulation the gap between baseline mean arterial pressure and lowest mean arterial pressure measured during 30 minutes after spinal anesthesia.
time frame: up to 30mins after spinal anesthesia
description: comparasion of significantly difference in the gap between baseline mean arterial pressure and lowest mean arterial pressure measured during 30 minutes after spinal anesthesia.
measure: prevention of hypotension bycalculation the gap baseline systolic and diastolic blood pressure and lowerst systolic and diastolic blood pressure
time frame: up to 30mins after spinal anesthesia
description: comparasion of significantly difference in the gap between baseline systolic arterial pressure and lowest systolic arterial pressure measured during 30 minutes after spinal anesthesia and the gap between baseline diastolic arterial pressure and lowest diastolic arterial pressure measured during 30 minutes after spinal anesthesia.
measure: occurrence ratio of shivering, nausea and vomiting, and usage doses of vasopressor (ephedrine or phenylephrine), and atropine
time frame: up to 30 min after spinal anesthesia
arm group label: ramosetron 0.3 mg
arm group type: Active Comparator
description: preparation of ramosetron 0.3 mg
arm group label: ondansetron 8 mg
arm group type: Active Comparator
description: preparation of ondansetron 8mg
arm group label: ondansetron 4 mg
arm group type: Active Comparator
description: preparation of ondansetron 4mg
arm group label: non 5-HT3 receptor antagonist
arm group type: Placebo Comparator
description: preparation of normal saline 5 ml
intervention type: Drug
intervention name: ramosetron
description: before 5 minutes spinal anesthesia, injection of ramosetron 0.3 mg
arm group label: ramosetron 0.3 mg
intervention type: Drug
intervention name: ondansetron
description: before 5 minutes spinal anesthesia, injection of ondansetron 8 mg
arm group label: ondansetron 8 mg
intervention type: Drug
intervention name: ondansetron
description: before 5 minutes spinal anesthesia, injection of ondansetron 4 mg
arm group label: ondansetron 4 mg
intervention type: Drug
intervention name: placebo
description: before 5 minutes spinal anesthesia, injection of normal saline 5 ml
arm group label: non 5-HT3 receptor antagonist
criteria: 
gender: All
minimum age: 20 Years
maximum age: 70 Years
healthy volunteers: No
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Hospital
investigator full name: Wonsik Ahn
investigator title: Associate Professor
mesh term: Hypotension
mesh term: Vomiting
mesh term: Ondansetron
mesh term: Ramosetron