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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03503292
Other study ID # 17-011283
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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