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Effect of Ramosetron in Prevention of Intrathecal Morphine Induced Nausea and Vomiting

Primary Purpose

Postoperative Nausea and Vomiting

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
ramosetron
Ondansetron
Sponsored by
Thammasat University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Nausea and Vomiting focused on measuring Total Knee Arthroplasty, Intrathecal Morphine, Ramosetron, Ondansetron, postoperative nausea and vomiting

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients aged 50-80 years with a diagnosis of primary OA undergoing unilateral TKA
  • American Society of Anesthesiologist (ASA) physical status I-III
  • Giving written informed consent

Exclusion Criteria:

  • Body mass index (BMI) > 35 kg/m2
  • Unable to undergo spinal anesthesia
  • History of allergic to study drugs
  • Impaired renal and/or hepatic function
  • Use of systemic steroids and anti-emetics within 24 hours of operation

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    ramosetron group

    ondansetron group

    Arm Description

    Patients received 0.3 mg of intravenous ramosetron before spinal anesthesia and intrathecal morphine

    Patients received 8 mg of intravenous ondansetron before spinal anesthesia and intrathecal morphine

    Outcomes

    Primary Outcome Measures

    Incidence rate of postoperative nausea and vomiting

    Secondary Outcome Measures

    number of patients require for anti-emetic medicine
    visual analog scale for pain

    Full Information

    First Posted
    July 6, 2016
    Last Updated
    July 9, 2016
    Sponsor
    Thammasat University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02830906
    Brief Title
    Effect of Ramosetron in Prevention of Intrathecal Morphine Induced Nausea and Vomiting
    Official Title
    Comparison of Ramosetron With Ondansetron for Prevention of Intrathecal Morphine Induced Nausea and Vomiting After Primary Total Knee Arthroplasty: A Randomized Control Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2014 (undefined)
    Primary Completion Date
    February 2015 (Actual)
    Study Completion Date
    March 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Thammasat University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    We would like to know the prophylactic anti-emetic effect of ramosetron compare to ondansetron in patient undergone total knee arthroplasty with spinal anesthesia and intrathecal morphine .
    Detailed Description
    The patients were allocated into 2 groups by computerized block randomization according to a computer generated randomization. Treatment allocations were contained in sealed envelopes that were opened after patient enrollment. Patients received either 8 mg of intravenous (IV) ondansetron or 0.3 mg of IV ramosetron 10 minutes before spinal anesthesia and intrathecal morphine. All of the unilateral TKAs were done by one orthopedic surgeon using the same minimally invasive surgical technique and the same prosthesis. Patients were monitored for incidence of Post Operative Nausea Vomiting(PONV) every 6 hours until 24 hours, and 24-48 hours postoperatively. Common adverse drug reactions associated with serotonin receptor antagonists (pruritus, dizziness, and headache) were also recorded. The sample size calculation was based on the ability to detect a difference in incidence of postoperative nausea in between the two groups of 40% i.e. 50% in the ondansetron arm, and 30% in the ramosetron arm, consistent with a previous study. Using a power of 80% (β=0.2) and a two sided significance level(alpha) of 0.05, 45 patients in each group were required.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Postoperative Nausea and Vomiting
    Keywords
    Total Knee Arthroplasty, Intrathecal Morphine, Ramosetron, Ondansetron, postoperative nausea and vomiting

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    99 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    ramosetron group
    Arm Type
    Experimental
    Arm Description
    Patients received 0.3 mg of intravenous ramosetron before spinal anesthesia and intrathecal morphine
    Arm Title
    ondansetron group
    Arm Type
    Active Comparator
    Arm Description
    Patients received 8 mg of intravenous ondansetron before spinal anesthesia and intrathecal morphine
    Intervention Type
    Drug
    Intervention Name(s)
    ramosetron
    Other Intervention Name(s)
    ramosetorn
    Intervention Description
    intravenous ramosetron 0.3 mg before spinal anesthesia and intrathecal morphine
    Intervention Type
    Drug
    Intervention Name(s)
    Ondansetron
    Intervention Description
    intravenous ondansetron 8 mg before spinal anesthesia and intrathecal morphine
    Primary Outcome Measure Information:
    Title
    Incidence rate of postoperative nausea and vomiting
    Time Frame
    48 hours after the operation
    Secondary Outcome Measure Information:
    Title
    number of patients require for anti-emetic medicine
    Time Frame
    48 hours after the operation
    Title
    visual analog scale for pain
    Time Frame
    48 hours after operation

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Patients aged 50-80 years with a diagnosis of primary OA undergoing unilateral TKA American Society of Anesthesiologist (ASA) physical status I-III Giving written informed consent Exclusion Criteria: Body mass index (BMI) > 35 kg/m2 Unable to undergo spinal anesthesia History of allergic to study drugs Impaired renal and/or hepatic function Use of systemic steroids and anti-emetics within 24 hours of operation
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    piya pinsornsak, md
    Organizational Affiliation
    Thammasat University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Effect of Ramosetron in Prevention of Intrathecal Morphine Induced Nausea and Vomiting

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