Pharmacogenomics and Post-Operative Nausea and Vomiting

Postoperative Nausea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03503292
• Other study ID #: 17-011283
• Status: Completed
• Phase: Phase 4
• Start date: May 2, 2018
• Est. completion date: December 30, 2019

Study information

• Verified date: October 2020
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: December 30, 2019
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Nausea
• Postoperative Nausea
• Postoperative Nausea and Vomiting
• Vomiting

Intervention

Drug:
• Granisetron
Rapid metabolizer will receive 1mg IV Granisetron
• Ondansetron
Poor or normal metabolizers will receive 4mg Ondansetron IV

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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

External Links

•   Mayo Clinic Clinical Trials