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Postoperative Nausea and Vomiting: Ramosetron Plus Aprepitant vs Palonosetron Plus Aprepitant

Primary Purpose

Postoperative Nausea and Vomiting

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
aprepitant
palonosetron
Ramosetron
Sponsored by
Kyungpook National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Nausea and Vomiting

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Non smoking, female patients, scheduled for laparoscopic cholecystectomy

Exclusion Criteria:

  • Patients with gastrointestinal disorder,
  • Patients with allergies to any study medication,
  • Patients who had received any sedatives, opioid, steroid or antiemetics within 24 h before surgery

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    aprepitant plus palonosetron

    aprepitant plus ramosetron

    Arm Description

    aprepitant 80 mg palonosetron 0.075 mg

    aprepitant 80 mg ramosetron 0.3 mg

    Outcomes

    Primary Outcome Measures

    The Incidence of Postoperative Nausea and Vomiting
    The incidence of postoperative nausea and vomiting during 24 hours postoperatively

    Secondary Outcome Measures

    Full Information

    First Posted
    October 31, 2015
    Last Updated
    April 20, 2017
    Sponsor
    Kyungpook National University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02597907
    Brief Title
    Postoperative Nausea and Vomiting: Ramosetron Plus Aprepitant vs Palonosetron Plus Aprepitant
    Official Title
    Postoperative Nausea and Vomiting: Ramosetron Plus Aprepitant vs Palonosetron Plus Aprepitant
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2014 (undefined)
    Primary Completion Date
    May 2015 (Actual)
    Study Completion Date
    July 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Kyungpook National University Hospital

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study was to compare the antiemetic efficacy of aprepitant plus palonosetron versus aprepitant plus ramosetron in high risk patients undergoing laparoscopic cholecystectomy.
    Detailed Description
    The purpose of this study was to compare the antiemetic efficacy of aprepitant plus palonosetron versus aprepitant plus ramosetron in high risk patients undergoing laparoscopic cholecystectomy. Study is performed during 24 hours after surgery.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Postoperative Nausea and Vomiting

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    88 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    aprepitant plus palonosetron
    Arm Type
    Experimental
    Arm Description
    aprepitant 80 mg palonosetron 0.075 mg
    Arm Title
    aprepitant plus ramosetron
    Arm Type
    Active Comparator
    Arm Description
    aprepitant 80 mg ramosetron 0.3 mg
    Intervention Type
    Drug
    Intervention Name(s)
    aprepitant
    Intervention Description
    aprepitant 80 mg is given to all patients before surgery
    Intervention Type
    Drug
    Intervention Name(s)
    palonosetron
    Intervention Description
    palonosetron 0.075 mg is given to patients in the aprepitant plus palonosetron group after induction of general anesthesia
    Intervention Type
    Drug
    Intervention Name(s)
    Ramosetron
    Intervention Description
    ramosetron 0.3 mg is given to patients in the aprepitant plus ramosetron group after induction of general anesthesia
    Primary Outcome Measure Information:
    Title
    The Incidence of Postoperative Nausea and Vomiting
    Description
    The incidence of postoperative nausea and vomiting during 24 hours postoperatively
    Time Frame
    24 hours

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Non smoking, female patients, scheduled for laparoscopic cholecystectomy Exclusion Criteria: Patients with gastrointestinal disorder, Patients with allergies to any study medication, Patients who had received any sedatives, opioid, steroid or antiemetics within 24 h before surgery

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Postoperative Nausea and Vomiting: Ramosetron Plus Aprepitant vs Palonosetron Plus Aprepitant

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