Pharmacogenomics and Post-Operative Nausea and Vomiting

October 4, 2020 updated by: Yvette N. Martin, MD-PhD, Mayo Clinic

Using Pharmacogenomics (PGx) Results to Guide Post-operative Nausea and Vomiting (PONV) Treatment Practices: A Pilot Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

92

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Episodes of Postoperative Nausea
Time Frame: 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.
0-48 hours post bariatric surgery
Episodes of Postoperative Vomiting
Time Frame: 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.
0-48 hours post bariatric surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 2, 2018

Primary Completion (Actual)

December 30, 2019

Study Completion (Actual)

December 30, 2019

Study Registration Dates

First Submitted

April 3, 2018

First Submitted That Met QC Criteria

April 11, 2018

First Posted (Actual)

April 19, 2018

Study Record Updates

Last Update Posted (Actual)

October 28, 2020

Last Update Submitted That Met QC Criteria

October 4, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17-011283

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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