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Dexmedetomidine or Dexmedetomidine Combined With Dexamethasone on Postoperative Nausea and Vomiting in Breast Cancer

Primary Purpose

Postoperative Nausea and Vomiting

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Dexmedetomidine
Dexmedetomidine and dexamethasone
Control
Sponsored by
Gachon University Gil Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Nausea and Vomiting

Eligibility Criteria

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

Inclusion Criteria:

  • ASA Physical status I or II female scheduled for breast conserving surgery of modified radical mastectomy.

Exclusion Criteria:

  • uncontrolled cardiovascular disease
  • history of chronic pain
  • smoker
  • previous history of steroid administraion
  • neoajuvant chemotherapy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Placebo Comparator

    Active Comparator

    Active Comparator

    Arm Label

    Control

    Dexmedetomidine

    Dexmedetomidine and dexamethasone

    Arm Description

    administration of 0.9% normal saline 10ml

    administration of 0.5ug/kg of dexmedetomidine (5ml)

    administration of 0.5 ug/kg of dexmedetomidine and dexamethasone 5mg (total 5ml)

    Outcomes

    Primary Outcome Measures

    Postoperative Nausea (Numeric Rating Scale for Nausea)
    Numeric rating scale for postoperative nausea (scores on a scale) (0-no symptoms; 10-worst symptoms imaginable). Ramosetron 0.3 mg was administered to patients with nausea >5 points on the numeric rating scale

    Secondary Outcome Measures

    Postoperative Vomiting (Number of Participants With Vomiting)
    frequencies of vomiting (number of participants with vomiting) 24 hour post-operatively
    Rhodes Index Score
    Rhodes Index of nausea, vomiting, and retching at 6 to 24 hours after surgery (ask 8 question about discomfort due to PONV and each questions are consist of 0~4 score) (minimal PONV 0 to maximal PONV 32) lower values represent a bettwer outcome

    Full Information

    First Posted
    August 30, 2015
    Last Updated
    August 11, 2020
    Sponsor
    Gachon University Gil Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02550795
    Brief Title
    Dexmedetomidine or Dexmedetomidine Combined With Dexamethasone on Postoperative Nausea and Vomiting in Breast Cancer
    Official Title
    Effects of Single Dose Dexmedetomidine or Dexmedetomidine Combined With Dexamethasone on Postoperative Nausea and Vomiting in Breast Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2015 (undefined)
    Primary Completion Date
    August 2016 (Actual)
    Study Completion Date
    December 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Gachon University Gil Medical Center

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Previous reports demonstrated that dexmedetomidine could reduce the incidence of postoperative nausea and vomiting (PONV). Dexamethason also had been commonly used for ajuvant drugs for preventing and reducing PONV. So investigator want to study about the effect of dexmedetomidine only or combined with dexamethasone for preventing PONV.
    Detailed Description
    Previous reports demonstrated that dexmedetomidine, a alpha 2 selective agonist could reduce the incidence of postoperative nausea and vomiting (PONV). Dexamethason also had been commonly used for ajuvant drugs for preventing and reducing PONV. So investigator want to study about the effect of dexmedetomidine only or combined with dexamethasone for preventing PONV.

    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
    150 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Control
    Arm Type
    Placebo Comparator
    Arm Description
    administration of 0.9% normal saline 10ml
    Arm Title
    Dexmedetomidine
    Arm Type
    Active Comparator
    Arm Description
    administration of 0.5ug/kg of dexmedetomidine (5ml)
    Arm Title
    Dexmedetomidine and dexamethasone
    Arm Type
    Active Comparator
    Arm Description
    administration of 0.5 ug/kg of dexmedetomidine and dexamethasone 5mg (total 5ml)
    Intervention Type
    Drug
    Intervention Name(s)
    Dexmedetomidine
    Other Intervention Name(s)
    DO
    Intervention Description
    administration of dexmedetomidine only
    Intervention Type
    Drug
    Intervention Name(s)
    Dexmedetomidine and dexamethasone
    Other Intervention Name(s)
    DD
    Intervention Description
    administration of dexmedetomidine and dexamethasone
    Intervention Type
    Drug
    Intervention Name(s)
    Control
    Other Intervention Name(s)
    OO
    Intervention Description
    administration of normal saline
    Primary Outcome Measure Information:
    Title
    Postoperative Nausea (Numeric Rating Scale for Nausea)
    Description
    Numeric rating scale for postoperative nausea (scores on a scale) (0-no symptoms; 10-worst symptoms imaginable). Ramosetron 0.3 mg was administered to patients with nausea >5 points on the numeric rating scale
    Time Frame
    Changes from baseline in postoperative nausea at 30 min
    Secondary Outcome Measure Information:
    Title
    Postoperative Vomiting (Number of Participants With Vomiting)
    Description
    frequencies of vomiting (number of participants with vomiting) 24 hour post-operatively
    Time Frame
    Changes from baseline in postoperative nausea at 30 min
    Title
    Rhodes Index Score
    Description
    Rhodes Index of nausea, vomiting, and retching at 6 to 24 hours after surgery (ask 8 question about discomfort due to PONV and each questions are consist of 0~4 score) (minimal PONV 0 to maximal PONV 32) lower values represent a bettwer outcome
    Time Frame
    assessed at 6 and 24 hour after operative end

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: ASA Physical status I or II female scheduled for breast conserving surgery of modified radical mastectomy. Exclusion Criteria: uncontrolled cardiovascular disease history of chronic pain smoker previous history of steroid administraion neoajuvant chemotherapy

    12. IPD Sharing Statement

    Learn more about this trial

    Dexmedetomidine or Dexmedetomidine Combined With Dexamethasone on Postoperative Nausea and Vomiting in Breast Cancer

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