<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/NCT03278522</url>
  </required_header>
  <id_info>
    <org_study_id>KUH1160112</org_study_id>
    <nct_id>NCT03278522</nct_id>
  </id_info>
  <brief_title>Ramosetron Pre-treatment for PONV and QT Prolongation</brief_title>
  <official_title>Comparison of Ramosetron Pre-treatment Time for Postoperative Nausea and Vomiting (PONV) and QTc Prolongation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Konkuk University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Konkuk University Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Ramosetron is commonly used to prevent postoperative nausea and vomiting (PONV) in the&#xD;
      Eastern Asia. The prolongation of QTc interval is a main side effect. In this study, the&#xD;
      pre-treatment time of ramosetron to decrease PONV, and QTc prolongation is compared.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This prospective study evaluate 42 female patients who underwent laparoscopic gynecologic&#xD;
      surgery under general anesthesia. Group I (n=21) receive 0.6mg of ramosetron at anesthesia&#xD;
      induction. Group R (n=21) received the same at the end of surgery. PONV is evaluated at&#xD;
      arrival to post-anesthetic care unit (PACU), before induction, discharge from PACU, 24-, 48-,&#xD;
      and 72- after discharge from PACU. The QTc interval is checked before anesthesia, at arrival&#xD;
      to PACU, and 24-h after discharge from PACU.&#xD;
&#xD;
      Forty two subjects are needed with an α value of 0.05, a power of 0.8, and effect size&#xD;
      difference of 0.9.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2017</start_date>
  <completion_date type="Actual">February 28, 2018</completion_date>
  <primary_completion_date type="Actual">February 28, 2018</primary_completion_date>
  <phase>Phase 4</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>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>QTc interval change</measure>
    <time_frame>within 10 min after arrival at PACU, and 24 hour after discharge from PACU</time_frame>
    <description>Difference of QTc interval from preoperative value</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">64</enrollment>
  <condition>PONV</condition>
  <condition>Prolonged QTc Interval</condition>
  <arm_group>
    <arm_group_label>ramosetron iv at induction (I)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>0.6mg of ramosetron is given to the patients intravenously at anesthesia induction</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ramosetron iv at recovery (R)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>0.6mg of ramosetron is given to the patients intravenously at end of surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ramosetron</intervention_name>
    <description>Intravenous ramosetron 0.6mg is given to the patients at the induction of anesthesia, or at the end of surgery</description>
    <arm_group_label>ramosetron iv at induction (I)</arm_group_label>
    <arm_group_label>ramosetron iv at recovery (R)</arm_group_label>
    <other_name>ramosetron pre-treatment</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients who underwent laparoscopic gynecologic surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  preoperative bradyarrhythmia in ECG&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ka Young Rhee, MD,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Konkuk University Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Lee Sung Ho</name>
      <address>
        <city>Seoul</city>
        <zip>05030</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>September 6, 2017</study_first_submitted>
  <study_first_submitted_qc>September 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 11, 2017</study_first_posted>
  <last_update_submitted>March 7, 2018</last_update_submitted>
  <last_update_submitted_qc>March 7, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 9, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Konkuk University Medical Center</investigator_affiliation>
    <investigator_full_name>Ka Young Rhee</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>ramosetron</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Postoperative Nausea and Vomiting</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ramosetron</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03278522
org study id: KUH1160112
nct id: NCT03278522
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Ramosetron is commonly used to prevent postoperative nausea and vomiting (PONV) in the
      Eastern Asia. The prolongation of QTc interval is a main side effect. In this study, the
      pre-treatment time of ramosetron to decrease PONV, and QTc prolongation is compared.
This prospective study evaluate 42 female patients who underwent laparoscopic gynecologic
      surgery under general anesthesia. Group I (n=21) receive 0.6mg of ramosetron at anesthesia
      induction. Group R (n=21) received the same at the end of surgery. PONV is evaluated at
      arrival to post-anesthetic care unit (PACU), before induction, discharge from PACU, 24-, 48-,
      and 72- after discharge from PACU. The QTc interval is checked before anesthesia, at arrival
      to PACU, and 24-h after discharge from PACU.

      Forty two subjects are needed with an α value of 0.05, a power of 0.8, and effect size
      difference of 0.9.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: QTc interval change
time frame: within 10 min after arrival at PACU, and 24 hour after discharge from PACU
description: Difference of QTc interval from preoperative value
arm group label: ramosetron iv at induction (I)
arm group type: Active Comparator
description: 0.6mg of ramosetron is given to the patients intravenously at anesthesia induction
arm group label: ramosetron iv at recovery (R)
arm group type: Active Comparator
description: 0.6mg of ramosetron is given to the patients intravenously at end of surgery
intervention type: Drug
intervention name: Ramosetron
description: Intravenous ramosetron 0.6mg is given to the patients at the induction of anesthesia, or at the end of surgery
arm group label: ramosetron iv at induction (I)
arm group label: ramosetron iv at recovery (R)
other name: ramosetron pre-treatment
criteria: 
gender: Female
minimum age: 19 Years
maximum age: 99 Years
healthy volunteers: No
last name: Ka Young Rhee, MD,PhD
role: Principal Investigator
affiliation: Konkuk University Medical Center
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Konkuk University Medical Center
investigator full name: Ka Young Rhee
investigator title: Associate Professor
mesh term: Postoperative Nausea and Vomiting
mesh term: Ramosetron
sharing ipd: Undecided