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Clinical Trials/NCT03503292
NCT03503292
Completed
Phase 4

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

Mayo Clinic1 site in 1 country92 target enrollmentMay 2, 2018

Overview

Phase
Phase 4
Intervention
Granisetron
Conditions
Postoperative Nausea
Sponsor
Mayo Clinic
Enrollment
92
Locations
1
Primary Endpoint
Episodes of Postoperative Vomiting
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 2, 2018
End Date
December 30, 2019
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Yvette N. Martin, MD-PhD

Principal Investigator

Mayo Clinic

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Arms & Interventions

CYP2D6 rapid metabolizer

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

Intervention: Granisetron

CYP2D6 normal metabolizer

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

Intervention: Ondansetron

Outcomes

Primary Outcomes

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.

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.

Study Sites (1)

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