<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/NCT04466046</url>
  </required_header>
  <id_info>
    <org_study_id>19-100</org_study_id>
    <nct_id>NCT04466046</nct_id>
  </id_info>
  <brief_title>The Effect on Anxiolytics With Type of Antiemetic Agents on Postoperative Nausea and Vomiting in High Risk Patients</brief_title>
  <official_title>The Effect on Anxiolytics With Type of Antiemetic Agents on Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Cholecystectomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Daegu Catholic University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Daegu Catholic University Medical Center</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Nausea and vomiting after surgery are one of the complications that occur after general&#xD;
      anesthesia, and the frequency is reported to range from 10% to 80% in the high-risk group.&#xD;
      Several studies have introduced drugs and methods to prevent nausea and vomiting after&#xD;
      surgery. Among them, midazolam administered before surgery is known to have anti-anxiolytic&#xD;
      and sedative effects on the prevention of nausea and vomiting after surgery. It has also been&#xD;
      reported to increase its effectiveness when administered with other antiemetic agents.&#xD;
&#xD;
      The purpose of this study is to compare the effects of administration of combination with&#xD;
      midazolam and different antiemetic agents on the prevention of postoperative nausea and&#xD;
      vomiting in high-risk patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This prospective study evaluates female, nonsmoking patients undergoing laparoscopic&#xD;
      cholecystectomy. The patients are divided into those with and without postoperative nausea&#xD;
      and vomiting. The purpose of this study is to compare and observe the effect of&#xD;
      administration of midazolam and two different antiemetics on prevention of postoperative&#xD;
      nausea and vomiting.&#xD;
&#xD;
      0.05mg/kg of midazolam is administered intravenously 10 minutes before surgery as a&#xD;
      pretreatment. 0.3mg ramosetron is administered intravenously right before the end of surgery&#xD;
      and 0.075mg palonosetron is administered intravenously immediately after induction of&#xD;
      anesthesia. The incidence of PONV, severity of nausea, use of rescue antiemetics, and pain&#xD;
      severity was evaluated at 2 hours, 24hours, and 48 hours after surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 4, 2019</start_date>
  <completion_date type="Actual">June 30, 2020</completion_date>
  <primary_completion_date type="Actual">June 30, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>percentage of patients receiving ramosetron or palonosetron in each groups</measure>
    <time_frame>48 hours after surgery</time_frame>
    <description>percentage of patients receiving ramosetron or palonosetron</description>
  </primary_outcome>
  <primary_outcome>
    <measure>severity of postoperative nausea in PONV group</measure>
    <time_frame>48 hours after surgery</time_frame>
    <description>0 = none, 1 = mild, 2 = moderate, 3 = severe</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>postoperative pain</measure>
    <time_frame>48 hours after surgery</time_frame>
    <description>numerical analog scale : 0 to 10</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">68</enrollment>
  <condition>Postoperative Nausea and Vomiting</condition>
  <arm_group>
    <arm_group_label>PONV group</arm_group_label>
    <description>Patients with PONV after administration of midazolam 0.05mg/kg with ramosetron 0.3mg or palonosetron 0.075mg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>no PONV group</arm_group_label>
    <description>Patients with no PONV after administration of midazolam 0.05mg/kg with ramosetron 0.3mg or palonosetron 0.075mg</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        female patients aged 20 to 65 with ASA physical status 1 or 2 undergoing laparoscopic&#xD;
        cholecystectomy&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  20-65 years old with American Society of Anesthesiologists (ASA) physical status 1-2&#xD;
             and scheduled for laparoscopic cholecystectomy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnant or breast feeding patients&#xD;
&#xD;
          -  smokers&#xD;
&#xD;
          -  patients with history of chronic opioid abuse&#xD;
&#xD;
          -  hypersensitivity to 5-HT3 receptor antagonists or analgesics&#xD;
&#xD;
          -  those who were antiemetic or opioid treatment within 24 hours prior to surgery&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jung A Lim, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Daegu Catholic University Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Daegu Catholic University Medical Center</name>
      <address>
        <city>Daegu</city>
        <state>Nam-gu</state>
        <zip>42472</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>July 2, 2020</study_first_submitted>
  <study_first_submitted_qc>July 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 10, 2020</study_first_posted>
  <last_update_submitted>October 31, 2022</last_update_submitted>
  <last_update_submitted_qc>October 31, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 2, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Daegu Catholic University Medical Center</investigator_affiliation>
    <investigator_full_name>Jung A</investigator_full_name>
    <investigator_title>Assistant professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nausea</mesh_term>
    <mesh_term>Vomiting</mesh_term>
    <mesh_term>Postoperative Nausea and Vomiting</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT04466046
org study id: 19-100
nct id: NCT04466046
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Nausea and vomiting after surgery are one of the complications that occur after general
      anesthesia, and the frequency is reported to range from 10% to 80% in the high-risk group.
      Several studies have introduced drugs and methods to prevent nausea and vomiting after
      surgery. Among them, midazolam administered before surgery is known to have anti-anxiolytic
      and sedative effects on the prevention of nausea and vomiting after surgery. It has also been
      reported to increase its effectiveness when administered with other antiemetic agents.

      The purpose of this study is to compare the effects of administration of combination with
      midazolam and different antiemetic agents on the prevention of postoperative nausea and
      vomiting in high-risk patients.
This prospective study evaluates female, nonsmoking patients undergoing laparoscopic
      cholecystectomy. The patients are divided into those with and without postoperative nausea
      and vomiting. The purpose of this study is to compare and observe the effect of
      administration of midazolam and two different antiemetics on prevention of postoperative
      nausea and vomiting.

      0.05mg/kg of midazolam is administered intravenously 10 minutes before surgery as a
      pretreatment. 0.3mg ramosetron is administered intravenously right before the end of surgery
      and 0.075mg palonosetron is administered intravenously immediately after induction of
      anesthesia. The incidence of PONV, severity of nausea, use of rescue antiemetics, and pain
      severity was evaluated at 2 hours, 24hours, and 48 hours after surgery.
observational model: Cohort
time perspective: Prospective
measure: percentage of patients receiving ramosetron or palonosetron in each groups
time frame: 48 hours after surgery
description: percentage of patients receiving ramosetron or palonosetron
measure: severity of postoperative nausea in PONV group
time frame: 48 hours after surgery
description: 0 = none, 1 = mild, 2 = moderate, 3 = severe
measure: postoperative pain
time frame: 48 hours after surgery
description: numerical analog scale : 0 to 10
arm group label: PONV group
description: Patients with PONV after administration of midazolam 0.05mg/kg with ramosetron 0.3mg or palonosetron 0.075mg
arm group label: no PONV group
description: Patients with no PONV after administration of midazolam 0.05mg/kg with ramosetron 0.3mg or palonosetron 0.075mg
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 65 Years
healthy volunteers: No
last name: Jung A Lim, MD
role: Study Chair
affiliation: Daegu Catholic University Medical Center
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Daegu Catholic University Medical Center
investigator full name: Jung A
investigator title: Assistant professor
mesh term: Nausea
mesh term: Vomiting
mesh term: Postoperative Nausea and Vomiting
sharing ipd: No