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Efficacy of Dexamethasone Added to Ramosetron for Preventing Postoperative Nausea and Vomiting in Highly Susceptible Patients Following Spine Surgery

Primary Purpose

Nausea, Vomiting

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
ramosetron with saline
ramosetron with dexamethasone
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Nausea focused on measuring highly susceptible patients following spine surgery

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Females
  • Ages 18 to 65 years old

Exclusion Criteria:

  • Patients who is taking steroid or who had been treated for the gastrointestinal disease
  • Patients who have troubles with the kidney or liver
  • Patients transferring to the ICU after the surgery
  • overfat patients
  • Patients who had taken antiemetics within 24 hours before the surgery

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Group A

    Group B

    Arm Description

    Group A : saline 1 ml + ramosetron 6μg/kg

    Group B : dexamethasone 4 mg + ramosetron 6μg/kg

    Outcomes

    Primary Outcome Measures

    the incidence of postoperative nausea and vomiting(PONV)
    incidence of overall postoperative nausea and vomiting (PONV) between combination of ramosetron and dexamethasone and ramosetron alone in highly susceptible patients

    Secondary Outcome Measures

    Full Information

    First Posted
    November 12, 2009
    Last Updated
    February 2, 2012
    Sponsor
    Yonsei University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01013012
    Brief Title
    Efficacy of Dexamethasone Added to Ramosetron for Preventing Postoperative Nausea and Vomiting in Highly Susceptible Patients Following Spine Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2008 (undefined)
    Primary Completion Date
    November 2008 (Actual)
    Study Completion Date
    November 2008 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Yonsei University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The purpose of this study is to study the efficacy of dexamethasone added to ramosetron for preventing postoperative nausea and vomiting in highly susceptible patients following spine surgery.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Nausea, Vomiting
    Keywords
    highly susceptible patients following spine surgery

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    94 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Group A
    Arm Type
    Active Comparator
    Arm Description
    Group A : saline 1 ml + ramosetron 6μg/kg
    Arm Title
    Group B
    Arm Type
    Experimental
    Arm Description
    Group B : dexamethasone 4 mg + ramosetron 6μg/kg
    Intervention Type
    Drug
    Intervention Name(s)
    ramosetron with saline
    Intervention Description
    Group A : saline 1 ml, ramosetron 6μg/kg
    Intervention Type
    Drug
    Intervention Name(s)
    ramosetron with dexamethasone
    Intervention Description
    Group B : dexamethasone 4 mg, ramosetron 6μg/kg
    Primary Outcome Measure Information:
    Title
    the incidence of postoperative nausea and vomiting(PONV)
    Description
    incidence of overall postoperative nausea and vomiting (PONV) between combination of ramosetron and dexamethasone and ramosetron alone in highly susceptible patients
    Time Frame
    After spinal surgery

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Females Ages 18 to 65 years old Exclusion Criteria: Patients who is taking steroid or who had been treated for the gastrointestinal disease Patients who have troubles with the kidney or liver Patients transferring to the ICU after the surgery overfat patients Patients who had taken antiemetics within 24 hours before the surgery

    12. IPD Sharing Statement

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