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Pharmacogenomics and Post-Operative Nausea and Vomiting

Sponsor
Mayo Clinic (Other)
Overall Status
Completed
CT.gov ID
NCT03503292
Collaborator
(none)
92
Enrollment
1
Location
2
Arms
19.9
Actual Duration (Months)
4.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The Researchers overall goal is to evaluate the benefit and utility of preemptive genotypic data to guide post-operative nausea and vomiting treatment in the bariatric surgical population. The hypothesis is that using genotypic variation in CYP2D6 to select the appropriate 5HT3 serotonin receptor antagonist to treat PONV will decrease rates of PONV in the bariatric surgical population.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
92 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Using Pharmacogenomics (PGx) Results to Guide Post-operative Nausea and Vomiting (PONV) Treatment Practices: A Pilot Study
Actual Study Start Date :
May 2, 2018
Actual Primary Completion Date :
Dec 30, 2019
Actual Study Completion Date :
Dec 30, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: CYP2D6 rapid metabolizer

Participants with CYP2D6 rapid metabolizer status will received granisetron for for post operative nausea and vomiting prophylaxis and treatment

Drug: Granisetron
Rapid metabolizer will receive 1mg IV Granisetron
Other Names:
  • Kytril

    		•
    Experimental: CYP2D6 normal metabolizer

    Participants with CYP2D6 poor or normal metabolizer status will received 4mg ondansetron for post operative nausea and vomiting prophylaxis and treatment

    Drug: Ondansetron
    Poor or normal metabolizers will receive 4mg Ondansetron IV
    Other Names:
  • Zofran

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Episodes of Postoperative Nausea [0-48 hours post bariatric surgery]

      The total number count of post operative nausea episodes were determined by nursing documentation or by treatment with rescue antinausea medication.

    2. Episodes of Postoperative Vomiting [0-48 hours post bariatric surgery]

      The total number count of post operative vomiting episodes were determined by nursing documentation or by treatment with rescue antinausea medication.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes

    Inclusion Criteria

    • A Mayo Clinic patient scheduled to undergo any bariatric surgical procedure, including Roux-en-Y gastric bypass, sleeve gastrectomy, or duodenal switch.

    • Patient age 18 or above.

    • Patients must understand and provide written informed consent and HIPAA authorization prior to initiation of any study-specific procedures.

    • Patient is willing to engage in a medication adjustment as part of their clinical visit (when needed).

    Exclusion Criteria

    • Patient with uncontrolled concurrent illness including psychiatric illness, or situations that would limit compliance with the study requirements or the ability to willingly give written informed consent.

    • Patients that deny access to their medical records for research purposes will not be included in this study. Also any patient who will be unable to have genetic testing at minimum of 1 week prior to scheduled surgery or with allergies to ondansetron or granisetron.

    • Any patient with prior genetic testing that is readily available in the medical record will be excluded from this study.

    • Any patient that is pregnant

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic in Rochester Rochester Minnesota United States 55905

    Sponsors and Collaborators

    • Mayo Clinic

    Investigators

    • Principal Investigator: Yvette N Martin, MD, PhD, Mayo Clinic

    Study Documents (Full-Text)

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Yvette N. Martin, MD-PhD, Principal Investigator, Mayo Clinic
    ClinicalTrials.gov Identifier:
    NCT03503292
    Other Study ID Numbers:
    • 17-011283
    First Posted:
    Apr 19, 2018
    Last Update Posted:
    Oct 28, 2020
    Last Verified:
    Oct 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Yvette N. Martin, MD-PhD, Principal Investigator, Mayo Clinic
    Pharmacogenetics
    CYP2D6
    Ondansetron
    Granisetron
    Bariatric surgery
    Additional relevant MeSH terms:
    Nausea
    Vomiting
    Postoperative Nausea and Vomiting
    Ondansetron
    Granisetron

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title CYP2D6 Rapid Metabolizer (Granisetron) CYP2D6 Normal Metabolizer (Ondansetron)
    Arm/Group Description Participants with CYP2D6 rapid metabolizer status received granisetron for for post operative nausea and vomiting prophylaxis and treatment Granisetron: Rapid metabolizer received 1mg IV Granisetron Participants with CYP2D6 poor or normal metabolizer status received 4mg ondansetron for post operative nausea and vomiting prophylaxis and treatment Ondansetron: Poor or normal metabolizers received 4mg Ondansetron IV
    Period Title: Overall Study
    STARTED 2 90
    COMPLETED 2 90
    NOT COMPLETED 0 0

    Baseline Characteristics

    Arm/Group Title CYP2D6 Rapid Metabolizer (Granisetron) CYP2D6 Normal Metabolizer (Ondansetron) Total
    Arm/Group Description Participants with CYP2D6 rapid metabolizer status received granisetron for for post operative nausea and vomiting prophylaxis and treatment Granisetron: Rapid metabolizer received 1mg IV Granisetron Participants with CYP2D6 poor or normal metabolizer status received 4mg ondansetron for post operative nausea and vomiting prophylaxis and treatment Ondansetron: Poor or normal metabolizers received 4mg Ondansetron IV Total of all reporting groups
    Overall Participants 2 90 92
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    52
    (21.2)
    47.1
    (13.0)
    47.2
    (13.1)
    Sex: Female, Male (Count of Participants)
    Female
    2
    100%
    78
    86.7%
    80
    87%
    Male
    0
    0%
    12
    13.3%
    12
    13%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    0
    0%
    0
    0%
    Asian
    0
    0%
    1
    1.1%
    1
    1.1%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    Black or African American
    0
    0%
    3
    3.3%
    3
    3.3%
    White
    2
    100%
    84
    93.3%
    86
    93.5%
    More than one race
    0
    0%
    0
    0%
    0
    0%
    Unknown or Not Reported
    0
    0%
    2
    2.2%
    2
    2.2%
    Region of Enrollment (participants) [Number]
    United States
    2
    100%
    90
    100%
    92
    100%
    Body Mass Index (BMI) (kg/m2) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [kg/m2]
    46.6
    (15.9)
    45.4
    (9.0)
    45.4
    (9.1)

    Outcome Measures

    1. Primary Outcome
    Title Episodes of Postoperative Nausea
    Description The total number count of post operative nausea episodes were determined by nursing documentation or by treatment with rescue antinausea medication.
    Time Frame 0-48 hours post bariatric surgery

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title CYP2D6 Rapid Metabolizer (Granisetron) CYP2D6 Normal Metabolizer (Ondansetron)
    Arm/Group Description Participants with CYP2D6 rapid metabolizer status received granisetron for for post operative nausea and vomiting prophylaxis and treatment Granisetron: Rapid metabolizer received 1mg IV Granisetron Participants with CYP2D6 poor or normal metabolizer status received 4mg ondansetron for post operative nausea and vomiting prophylaxis and treatment Ondansetron: Poor or normal metabolizers received 4mg Ondansetron IV
    Measure Participants 2 90
    Number [episodes]
    0
    16
    2. Primary Outcome
    Title Episodes of Postoperative Vomiting
    Description The total number count of post operative vomiting episodes were determined by nursing documentation or by treatment with rescue antinausea medication.
    Time Frame 0-48 hours post bariatric surgery

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title CYP2D6 Rapid Metabolizer (Granisetron) CYP2D6 Normal Metabolizer (Ondansetron)
    Arm/Group Description Participants with CYP2D6 rapid metabolizer status received granisetron for for post operative nausea and vomiting prophylaxis and treatment Granisetron: Rapid metabolizer received 1mg IV Granisetron Participants with CYP2D6 poor or normal metabolizer status received 4mg ondansetron for post operative nausea and vomiting prophylaxis and treatment Ondansetron: Poor or normal metabolizers received 4mg Ondansetron IV
    Measure Participants 2 90
    Number [episodes]
    0
    4

    Adverse Events

    Time Frame Adverse Events were collect from baseline (surgery) to one week post surgery, for approximately one week.
    Adverse Event Reporting Description
    Arm/Group Title CYP2D6 Rapid Metabolizer (Granisetron) CYP2D6 Normal Metabolizer (Ondansetron)
    Arm/Group Description Participants with CYP2D6 rapid metabolizer status received granisetron for for post operative nausea and vomiting prophylaxis and treatment Granisetron: Rapid metabolizer received 1mg IV Granisetron Participants with CYP2D6 poor or normal metabolizer status received 4mg ondansetron for post operative nausea and vomiting prophylaxis and treatment Ondansetron: Poor or normal metabolizers received 4mg Ondansetron IV
    All Cause Mortality
    CYP2D6 Rapid Metabolizer (Granisetron) CYP2D6 Normal Metabolizer (Ondansetron)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/2 (0%) 0/90 (0%)
    Serious Adverse Events
    CYP2D6 Rapid Metabolizer (Granisetron) CYP2D6 Normal Metabolizer (Ondansetron)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/2 (0%) 0/90 (0%)
    Other (Not Including Serious) Adverse Events
    CYP2D6 Rapid Metabolizer (Granisetron) CYP2D6 Normal Metabolizer (Ondansetron)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/2 (0%) 0/90 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    All Principal Investigators ARE employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Yvette N. Martin McGrew, M.D., Ph.D.
    Organization Mayo Clinic
    Phone 507-255-7481
    Email martin.yvette@mayo.edu
    Responsible Party:
    Yvette N. Martin, MD-PhD, Principal Investigator, Mayo Clinic
    ClinicalTrials.gov Identifier:
    NCT03503292
    Other Study ID Numbers:
    • 17-011283
    First Posted:
    Apr 19, 2018
    Last Update Posted:
    Oct 28, 2020
    Last Verified:
    Oct 1, 2020