Postoperative Nausea
Conditions
Keywords
Pharmacogenetics, CYP2D6, Ondansetron, Granisetron, Bariatric surgery
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.
Interventions
DRUGGranisetron
Rapid metabolizer will receive 1mg IV Granisetron
DRUGOndansetron
Poor or normal metabolizers will receive 4mg Ondansetron IV
Sponsors
Mayo Clinic
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Episodes of Postoperative Nausea | 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. |
| Episodes of Postoperative Vomiting | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CYP2D6 Rapid Metabolizer (Granisetron) Participants with CYP2D6 rapid metabolizer status received granisetron for for post operative nausea and vomiting prophylaxis and treatment
Granisetron: Rapid metabolizer received 1mg IV Granisetron | 2 |
| CYP2D6 Normal Metabolizer (Ondansetron) Participants with CYP2D6 poor or normal metabolizer status received 4mg ondansetron for post operative nausea and vomiting prophylaxis and treatment
Ondansetron: Poor or normal metabolizers received 4mg Ondansetron IV | 90 |
| Total | 92 |
Baseline characteristics
| Characteristic | CYP2D6 Rapid Metabolizer (Granisetron) | CYP2D6 Normal Metabolizer (Ondansetron) | Total |
|---|---|---|---|
| Age, Continuous | 52 years STANDARD_DEVIATION 21.2 | 47.1 years STANDARD_DEVIATION 13 | 47.2 years STANDARD_DEVIATION 13.1 |
| Body Mass Index (BMI) | 46.6 kg/m2 STANDARD_DEVIATION 15.9 | 45.4 kg/m2 STANDARD_DEVIATION 9 | 45.4 kg/m2 STANDARD_DEVIATION 9.1 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) White | 2 Participants | 84 Participants | 86 Participants |
| Region of Enrollment United States | 2 participants | 90 participants | 92 participants |
| Sex: Female, Male Female | 2 Participants | 78 Participants | 80 Participants |
| Sex: Female, Male Male | 0 Participants | 12 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 2 | 0 / 90 |
| other Total, other adverse events | 0 / 2 | 0 / 90 |
| serious Total, serious adverse events | 0 / 2 | 0 / 90 |
Outcome results
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.
Time frame: 0-48 hours post bariatric surgery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CYP2D6 Rapid Metabolizer (Granisetron) | Episodes of Postoperative Nausea | 0 episodes |
| CYP2D6 Normal Metabolizer (Ondansetron) | Episodes of Postoperative Nausea | 16 episodes |
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.
Time frame: 0-48 hours post bariatric surgery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CYP2D6 Rapid Metabolizer (Granisetron) | Episodes of Postoperative Vomiting | 0 episodes |
| CYP2D6 Normal Metabolizer (Ondansetron) | Episodes of Postoperative Vomiting | 4 episodes |