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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CYP2D6 rapid metabolizer | Experimental | Participants with CYP2D6 rapid metabolizer status will received granisetron for for post operative nausea and vomiting prophylaxis and treatment |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Granisetron | Drug | Rapid metabolizer will receive 1mg IV Granisetron |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Yvette N Martin, MD, PhD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | CYP2D6 Normal Metabolizer (Ondansetron) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Number | episodes | 0-48 hours post bariatric surgery |
|
Adverse Events were collect from baseline (surgery) to one week post surgery, for approximately one week.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Yvette N. Martin McGrew, M.D., Ph.D. | Mayo Clinic | 507-255-7481 | martin.yvette@mayo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 20, 2018 | Oct 2, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D020250 | Postoperative Nausea and Vomiting |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009325 | Nausea |
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| ID | Term |
|---|---|
| D017829 | Granisetron |
| D017294 | Ondansetron |
| ID | Term |
|---|---|
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D007191 | Indazoles |
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| Ondansetron | Drug | Poor or normal metabolizers will receive 4mg Ondansetron IV |
|
|
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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m2 |
|
|
|
| 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. | Posted | Number | episodes | 0-48 hours post bariatric surgery |
|
|
|
| 0 |
| 2 |
| 0 |
| 2 |
| 0 |
| 2 |
| EG001 | 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 | 0 | 90 | 0 | 90 | 0 | 90 |
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| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D014839 | Vomiting |
| D011720 |
| Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D007093 | Imidazoles |
| D002227 | Carbazoles |
| D007211 | Indoles |
| D006575 | Heterocyclic Compounds, 3-Ring |