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Comparison of Palonosetron and Ramosetron for Preventing Patient-controlled Analgesia Related Nausea and Vomiting Following Spine Surgery

Primary Purpose

Postoperative Nausea and Vomiting

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ramosetron
palonosetron
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Nausea and Vomiting focused on measuring palonosetron, ramosetron, PONV, opioid

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. patients (20-65 years) scheduled for lumbar spinal surgery in prone position between August 2011 and July 2012.
  2. All patients were using opioid-based IV-PCA postoperatively for pain control

Exclusion Criteria:

  1. gastrointestinal disease
  2. renal dysfunction
  3. hepatic dysfunction
  4. diabetes mellitus on insulin
  5. pregnancy
  6. use of steroid, opioid, antiemetics within 1 day before surgery
  7. inability to understand verbal rating scale (VRS)
  8. inability to use PCA device

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    ramosetron

    palonosetron

    Arm Description

    Outcomes

    Primary Outcome Measures

    verbal numeric scale
    At each time point, frequency and intensity (verbal numeric scale, 0-10, 0: no nausea, 10: maximum) of nausea, frequency of vomiting, rescue antiemetic use were recorded and compared between groups.

    Secondary Outcome Measures

    Full Information

    First Posted
    March 26, 2013
    Last Updated
    February 17, 2014
    Sponsor
    Yonsei University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01825733
    Brief Title
    Comparison of Palonosetron and Ramosetron for Preventing Patient-controlled Analgesia Related Nausea and Vomiting Following Spine Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2011 (undefined)
    Primary Completion Date
    July 2012 (Actual)
    Study Completion Date
    July 2012 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Postoperative pain, the great concern for the patients undergoing spine surgery, has led to common use of opioid-based intravenous patient-controlled analgesia (IV-PCA) postoperatively. Opioid-based IV-PCA offers better pain control, which could facilitate early recovery, rehabilitation and increase patient satisfaction. However, its use inevitably increases the incidence of postoperative nausea and vomiting (PONV), another great discomfort, as high as 80% in patients with multiple risk factors.Therefore, there have been consistent efforts to prevent PONV with multimodal therapies such as risk stratification, modification and preventive use of antiemetics. Of all antiemetics, 5-hydroxytryptamine (5-HT3) antagonist, especially ondansetron, is most commonly used and extensively studied to reduce PONV because of its efficacy and fewer side effects.[8] However, its efficacy is not quite satisfactory when it comes to PONV associated with opioid-based IV-PCA. Recently, there are many reports comparing the antiemetic efficacy between ondansetron and the 2 newly developed 5-HT3 antagonists, ramosetron and palonosetron. Ramosetron is known to have a higher affinity and longer duration of binding to 5-HT3 receptor, therefore exhibits potent and sustained anti-emetic effect than previously developed 5-HT3 antagonists.Palonosetron has a unique allosteric binding to the 5-HT3 receptor, which brings a higher affinity, longer duration of action and longer elimination half-time.According to the previous studies, both ramosetron and palonosetron showed superior antiemetic efficacy for PONV associated with opioid-based IV-PCA to ondansetron as expected by their theoretical advantages. However, it has never been evaluated which one has superior antiemetic efficacy for opioid-based IV-PCA associated PONV. Therefore, in this study, we tried to evaluate the relative antiemetic efficacy of ramosetron and palonosetron in controlling opioid-based IV-PCA related PONV.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Postoperative Nausea and Vomiting
    Keywords
    palonosetron, ramosetron, PONV, opioid

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    196 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    ramosetron
    Arm Type
    Experimental
    Arm Title
    palonosetron
    Arm Type
    Active Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    ramosetron
    Intervention Description
    Ramosetron 0.3 mg was mixed to the PCA. Same dose of drug was administered 10 minutes before the end of surgery according to the allocated group.
    Intervention Type
    Drug
    Intervention Name(s)
    palonosetron
    Intervention Description
    palonosetrno 0.075 mg was mixed to the PCA. Same dose of drug was administered 10 minutes before the end of surgery according to the allocated group.
    Primary Outcome Measure Information:
    Title
    verbal numeric scale
    Description
    At each time point, frequency and intensity (verbal numeric scale, 0-10, 0: no nausea, 10: maximum) of nausea, frequency of vomiting, rescue antiemetic use were recorded and compared between groups.
    Time Frame
    change of antiemetic efficacy for 5 time points ( postanesthesia care unit, 0-6 h, 6-24 h, 24-48 h, 48-72 h after operation)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: patients (20-65 years) scheduled for lumbar spinal surgery in prone position between August 2011 and July 2012. All patients were using opioid-based IV-PCA postoperatively for pain control Exclusion Criteria: gastrointestinal disease renal dysfunction hepatic dysfunction diabetes mellitus on insulin pregnancy use of steroid, opioid, antiemetics within 1 day before surgery inability to understand verbal rating scale (VRS) inability to use PCA device

    12. IPD Sharing Statement

    Learn more about this trial

    Comparison of Palonosetron and Ramosetron for Preventing Patient-controlled Analgesia Related Nausea and Vomiting Following Spine Surgery

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