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Pharmacogenomics and Post-Operative Nausea and Vomiting

YN
Overseen byYvette N Martin, MD, PhD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Waitlist Available
Sponsor: Mayo Clinic
No Placebo Group
Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

YN

Yvette N Martin, MD, PhD

Principal Investigator

Mayo Clinic

Eligibility Criteria

Inclusion Criteria

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

Interventions

  • Granisetron (5HT3 Serotonin Receptor Antagonist)
  • Ondansetron (5HT3 Serotonin Receptor Antagonist)
Participant Groups
2Treatment groups
Experimental Treatment
Group I: CYP2D6 rapid metabolizerExperimental Treatment1 Intervention
Participants with CYP2D6 rapid metabolizer status will received granisetron for for post operative nausea and vomiting prophylaxis and treatment
Group II: CYP2D6 normal metabolizerExperimental Treatment1 Intervention
Participants with CYP2D6 poor or normal metabolizer status will received 4mg ondansetron for post operative nausea and vomiting prophylaxis and treatment

Find a Clinic Near You

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials
3,427
Recruited
3,221,000+

Dr. Gianrico Farrugia

Mayo Clinic

Chief Executive Officer since 2019

MD from University of Malta Medical School

Dr. Richard Afable profile image

Dr. Richard Afable

Mayo Clinic

Chief Medical Officer

MD from Loyola Stritch School of Medicine