Pharmacogenomics and Post-Operative Nausea and Vomiting

NCT03503292 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 17-011283
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Nausea

Keywords

Pharmacogenetics; CYP2D6; Ondansetron; Granisetron; Bariatric surgery

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

CYP2D6 rapid metabolizer

EXPERIMENTAL

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

Drug: Granisetron

CYP2D6 normal metabolizer

EXPERIMENTAL

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

Drug: Ondansetron

Interventions

Granisetron DRUG

Rapid metabolizer will receive 1mg IV Granisetron

Also known as: Kytril

CYP2D6 rapid metabolizer

Ondansetron DRUG

Poor or normal metabolizers will receive 4mg Ondansetron IV

Also known as: Zofran

CYP2D6 normal metabolizer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

Granisetron; Ondansetron

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Indazoles; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Imidazoles; Carbazoles; Indoles; Heterocyclic Compounds, 3-Ring

Results Point of Contact

• Title: Yvette N. Martin McGrew, M.D., Ph.D.
• Organization: Mayo Clinic

martin.yvette@mayo.edu

507-255-7481

Study Officials

• Yvette N Martin, MD, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 3, 2018
• First Posted: April 19, 2018
• Study Start: May 2, 2018
• Primary Completion: December 30, 2019
• Study Completion: December 30, 2019
• Last Updated: October 28, 2020
• Results First Posted: October 28, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)