Pharmacogenomics and Post-Operative Nausea and Vomiting

Study Overview
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Brief Summary
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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.

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

Conditions
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Postoperative Nausea

Intervention / Treatment
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* Drug: Granisetron
* Drug: Ondansetron


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CYP2D6 rapid metabolizer<br>Participants with CYP2D6 rapid metabolizer status will received granisetron for for post operative nausea and vomiting prophylaxis and treatment | Drug: Granisetron<br>* Rapid metabolizer will receive 1mg IV Granisetron<br>* Other names: Kytril;|
| Experimental: CYP2D6 normal metabolizer<br>Participants with CYP2D6 poor or normal metabolizer status will received 4mg ondansetron for post operative nausea and vomiting prophylaxis and treatment | Drug: Ondansetron<br>* Poor or normal metabolizers will receive 4mg Ondansetron IV<br>* Other names: Zofran;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Episodes of Postoperative Nausea | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pharmacogenetics, CYP2D6, Ondansetron, Granisetron, Bariatric surgery