Back to resultsPharmacogenomics and Post-Operative Nausea and Vomiting
Primary Purpose
Postoperative Nausea
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Granisetron
Ondansetron
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Nausea focused on measuring Pharmacogenetics, CYP2D6, Ondansetron, Granisetron, Bariatric surgery
Eligibility Criteria
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
Sites / Locations
- Mayo Clinic in Rochester
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
CYP2D6 rapid metabolizer
CYP2D6 normal metabolizer
Arm Description
Participants with CYP2D6 rapid metabolizer status will received granisetron for for post operative nausea and vomiting prophylaxis and treatment
Participants with CYP2D6 poor or normal metabolizer status will received 4mg ondansetron for post operative nausea and vomiting prophylaxis and treatment
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03503292
Brief Title
Pharmacogenomics and Post-Operative Nausea and Vomiting
Official Title
Using Pharmacogenomics (PGx) Results to Guide Post-operative Nausea and Vomiting (PONV) Treatment Practices: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
May 2, 2018 (Actual)
Primary Completion Date
December 30, 2019 (Actual)
Study Completion Date
December 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Nausea
Keywords
Pharmacogenetics, CYP2D6, Ondansetron, Granisetron, Bariatric surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
92 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CYP2D6 rapid metabolizer
Arm Type
Experimental
Arm Description
Participants with CYP2D6 rapid metabolizer status will received granisetron for for post operative nausea and vomiting prophylaxis and treatment
Arm Title
CYP2D6 normal metabolizer
Arm Type
Experimental
Arm Description
Participants with CYP2D6 poor or normal metabolizer status will received 4mg ondansetron for post operative nausea and vomiting prophylaxis and treatment
Intervention Type
Drug
Intervention Name(s)
Granisetron
Other Intervention Name(s)
Kytril
Intervention Description
Rapid metabolizer will receive 1mg IV Granisetron
Intervention Type
Drug
Intervention Name(s)
Ondansetron
Other Intervention Name(s)
Zofran
Intervention Description
Poor or normal metabolizers will receive 4mg Ondansetron IV
Primary Outcome Measure Information:
Title
Episodes of Postoperative Nausea
Description
The total number count of post operative nausea episodes were determined by nursing documentation or by treatment with rescue antinausea medication.
Time Frame
0-48 hours post bariatric surgery
Title
Episodes of Postoperative Vomiting
Description
The total number count of post operative vomiting episodes were determined by nursing documentation or by treatment with rescue antinausea medication.
Time Frame
0-48 hours post bariatric surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yvette N Martin, MD, PhD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Pharmacogenomics and Post-Operative Nausea and Vomiting
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