<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/NCT03017222</url>
  </required_header>
  <id_info>
    <org_study_id>4-2015-0435</org_study_id>
    <nct_id>NCT03017222</nct_id>
  </id_info>
  <brief_title>Therapeutic Efficacy of Ramosetron for Treatment of Established PONV After Laparoscopic Surgery</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yonsei University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yonsei University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients who had at least two risk factors of PONV (Postoperative nausea and vomiting) and&#xD;
      underwent laparoscopic surgeries under general anesthesia were assessed for eligibility.&#xD;
      Patients who developed PONV within the first 2 hours after anesthesia received intravenously,&#xD;
      in a randomized double-blind manner, ondansetron 4 mg or ramosetron 0.3 mg. Patients were&#xD;
      then observed for 24 hours after drug administration. The incidence of nausea and vomiting,&#xD;
      severity of nausea, requirements for rescue antiemetic and adverse effects at 0-2 and 2-24&#xD;
      hours after drug administration were evaluated. The primary endpoint was the rate of patients&#xD;
      exhibiting complete response, defined as no emesis and no further rescue antiemetic&#xD;
      medication for 24 hours after drug administration.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 7, 2015</start_date>
  <completion_date type="Actual">April 2, 2016</completion_date>
  <primary_completion_date type="Actual">April 2, 2016</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>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>ratio of complete response</measure>
    <time_frame>24 hours after administration of study drug</time_frame>
    <description>complete response is defined as no retching or vomiting and no secondary rescue antiemetic administration</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>incidence of nausea and vomiting</measure>
    <time_frame>24 hours after administration of study drug</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Abdominal Mass</condition>
  <arm_group>
    <arm_group_label>Ondansetron group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Ramosetron group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ondansetron</intervention_name>
    <description>Ondansetron also has been reported as effective prophylactic and therapeutic 5-HT3 receptor antagonist for the treatment of PONV. Ramosetron has been shown to have a very strong effect for preventing PONV in previous meta-analyses, but in recent report, its clinical significance may be questioned to request for additional study.</description>
    <arm_group_label>Ondansetron group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ramosetron</intervention_name>
    <description>Ramosetron is a newly developed selective 5-HT3 (5 hydroxytryptamine 3) receptor antagonist with longer duration of action up to 48hours and higher receptor affinity, than its previously developed congeners, including ondansetron.</description>
    <arm_group_label>Ramosetron group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age 19-65 years&#xD;
&#xD;
          -  patients undergoing elective laparoscopic surgery under inhalational anesthesia&#xD;
&#xD;
          -  duration of surgery between 30 min to 4 h&#xD;
&#xD;
          -  ASA (American Society of Anesthesiologists) physical status I or II, and patients who&#xD;
             had at least two of these risk factors&#xD;
&#xD;
          -  female gender, history of motion sickness (MS) or PONV, nonsmoking, and the use of&#xD;
             postoperative opioids.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients with history of being allergic to 5-HT3 receptor antagonist&#xD;
&#xD;
          -  patients with history of anticancer chemotherapy&#xD;
&#xD;
          -  chronic opioids use, alcohol abuse, or drug abuse&#xD;
&#xD;
          -  patients who took antiemetic medication within 24 h before surgery, steroids within 24&#xD;
             h before surgery or 24 h after surgery&#xD;
&#xD;
          -  presence of renal (serum Cr &gt; 1.6 mg/dl)&#xD;
&#xD;
          -  hepatic(liver enzymes more than 2 times normal value) insufficiency&#xD;
&#xD;
          -  patients converted to open laparotomy&#xD;
&#xD;
          -  patient who are pregnant or breast-feeding&#xD;
&#xD;
          -  patient with borderline QTc(corrected QT interval) prolongation (&gt; 430 ms for male,&#xD;
             &gt;450 ms for female)&#xD;
&#xD;
          -  patient not able to understand the scoring of pain or express the degree of PONV.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 1, 2017</study_first_submitted>
  <study_first_submitted_qc>January 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 11, 2017</study_first_posted>
  <last_update_submitted>February 10, 2019</last_update_submitted>
  <last_update_submitted_qc>February 10, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 12, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT03017222
org study id: 4-2015-0435
nct id: NCT03017222
lead sponsor: 
has dmc: No
Patients who had at least two risk factors of PONV (Postoperative nausea and vomiting) and
      underwent laparoscopic surgeries under general anesthesia were assessed for eligibility.
      Patients who developed PONV within the first 2 hours after anesthesia received intravenously,
      in a randomized double-blind manner, ondansetron 4 mg or ramosetron 0.3 mg. Patients were
      then observed for 24 hours after drug administration. The incidence of nausea and vomiting,
      severity of nausea, requirements for rescue antiemetic and adverse effects at 0-2 and 2-24
      hours after drug administration were evaluated. The primary endpoint was the rate of patients
      exhibiting complete response, defined as no emesis and no further rescue antiemetic
      medication for 24 hours after drug administration.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: ratio of complete response
time frame: 24 hours after administration of study drug
description: complete response is defined as no retching or vomiting and no secondary rescue antiemetic administration
measure: incidence of nausea and vomiting
time frame: 24 hours after administration of study drug
arm group label: Ondansetron group
arm group type: Active Comparator
arm group label: Ramosetron group
arm group type: Experimental
intervention type: Drug
intervention name: Ondansetron
description: Ondansetron also has been reported as effective prophylactic and therapeutic 5-HT3 receptor antagonist for the treatment of PONV. Ramosetron has been shown to have a very strong effect for preventing PONV in previous meta-analyses, but in recent report, its clinical significance may be questioned to request for additional study.
arm group label: Ondansetron group
intervention type: Drug
intervention name: Ramosetron
description: Ramosetron is a newly developed selective 5-HT3 (5 hydroxytryptamine 3) receptor antagonist with longer duration of action up to 48hours and higher receptor affinity, than its previously developed congeners, including ondansetron.
arm group label: Ramosetron group
criteria: 
gender: All
minimum age: 19 Years
maximum age: 65 Years
healthy volunteers: No
responsible party type: Sponsor
mesh term: Ondansetron
mesh term: Ramosetron