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Pharmacogenomics and Post-Operative Nausea and Vomiting

NCT ID: NCT03503292

Last Updated: 2020-10-28

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-02

Study Completion Date

2019-12-30

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.

Detailed Description

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Conditions

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Postoperative Nausea

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CYP2D6 rapid metabolizer

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

Group Type EXPERIMENTAL

Granisetron

Intervention Type DRUG

Rapid metabolizer will receive 1mg IV 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

Group Type EXPERIMENTAL

Ondansetron

Intervention Type DRUG

Poor or normal metabolizers will receive 4mg Ondansetron IV

Interventions

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Granisetron

Rapid metabolizer will receive 1mg IV Granisetron

Intervention Type DRUG

Ondansetron

Poor or normal metabolizers will receive 4mg Ondansetron IV

Intervention Type DRUG

Other Intervention Names

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Kytril Zofran

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Yvette N. Martin, MD-PhD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yvette N Martin, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

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https://www.mayo.edu/research/clinical-trials

Mayo Clinic Clinical Trials

Other Identifiers

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17-011283

Identifier Type: -

Identifier Source: org_study_id