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OpenTrials
Completed

NCT Number: NCT03503292

Pharmacogenomics and Post-Operative Nausea and Vomiting

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.

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Key information

Conditions

Postoperative Nausea Nausea Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Nausea and Vomiting Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Granisetron

Drug

Rapid metabolizer will receive 1mg IV Granisetron

Other names: Kytril

ondansetron

Drug

Poor or normal metabolizers will receive 4mg Ondansetron IV

Other names: Zofran

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Apr 19, 2018
Registry last updated
Oct 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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