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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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Recent evidence suggests multiple drug therapy is superior to single agents. The study compares the incidence of nausea, vomiting, need for rescue medication, prolonged PACU time, and unplanned hospital admission in patients with high risk for PONV treated with oral aprepitant with or without transdermal scopolamine preoperatively.
Postoperative nausea and vomiting (PONV) is a serious problem complicating surgery. PONV has an overall incidence of 30% and a 70% incidence in high-risk patients. PONV yields unplanned hospital admission, pulmonary aspiration, esophageal rupture, electrolyte abnormalities, dehydration, and delayed discharge from the postanesthesia care unit (PACU). Additional use of resources costs the health care industry hundreds of millions of dollars annually. Patient satisfaction is greatly improved when PONV is prevented.4 PONV etiology is multifactorial and the treatment is multimodal.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aprepitant | Placebo Comparator | Oral Aprepitant pill and placebo transdermal patch at least 1 hour prior to surgical procedure. Emend (Aprepitant) + Placebo |
|
| Scopolamine | Active Comparator | Oral Aprepitant pill and Scopolamine transdermal patch at least 1 hour prior to surgical procedure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aprepitant | Drug | 40mg tablet |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Postoperative Nausea and Vomiting | 0-24 hours |
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Inclusion Criteria:
Patient must be between 18 and 65 years of age.
Patient's ASA (American Society of Anesthesiologist) class must be between 1 and 3.
If patient is currently on oral contraceptive to prevent pregnancy, she must be willing to use a back up form of birth control for one month post study.
Patient must have 1 FACTOR to qualify
Exclusion Criteria:
Patients with a history of vomiting due to middle ear infection, nervous system disorder, or any other condition.
The surgical procedure is less than 1 hour.
The patient is pregnant or breast feeding.
The patient has taken antiemetic medication in previous 24 hours.
Patients with narrow-angle glaucoma.
Allergy to belladonna alkaloids.
Hypersensitivity to barbiturates.
Patient taking any of the following medications:
Male patients with prostate hypertrophy.
Patients with severe hepatic disease.
Patients on Chemotherapy and taking Aprepitant.
Patients with fever.
Patients with sepsis.
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| Name | Affiliation | Role |
|---|---|---|
| Jay Horrow, MD | Drexel University College of Medicine | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hahnemann University Hospital | Philadelphia | Pennsylvania | 19102 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Aprepitant and Placebo Transdermal Patch | Oral Aprepitant pill 40 mg tablet and placebo transdermal patch at least 1 hour prior to surgical procedure. |
| FG001 | Aprepitant and Scopolamine Transdermal Patch | Oral Aprepitant pill, 40 mg tablet and Scopolamine transdermal patch, 1.5 mg patch delivering transdermally in vivo approximately 1.0mg over 3 days, at least 1 hour prior to surgical procedure. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Aprepitant and Placebo Transdermal Patch | Oral Aprepitant pill, 40 mg tablet and placebo transdermal patch at least 1 hour prior to surgical procedure. |
| BG001 | Aprepitant and Scopolamine Transdermal Patch |
| 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 | Number of Participants With Postoperative Nausea and Vomiting | Posted | Number | participants | 0-24 hours |
|
0-24 hours
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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 | Aprepiatnt | Oral Aprepitant pill and placebo transdermal patch at least 1 hour prior to surgical procedure. Emend (Aprepitant) + Placebo: 40mg tablet |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dry mouth | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Green | Drexel university | 215-762-1524 | micheal.green@drexelmed.edu |
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| ID | Term |
|---|---|
| D009325 | Nausea |
| D014839 | Vomiting |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077608 | Aprepitant |
| D012601 | Scopolamine |
| ID | Term |
|---|---|
| D009025 | Morpholines |
| D010078 | Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Scopolamine | Drug | 1.5 mg patch delivering transdermally in vivo approx. 1.0mg over 3 days |
|
|
Oral Aprepitant pill, 40 mg tablet and Scopolamine transdermal patch, 1.5 mg patch delivering transdermally in vivo approximately 1.0mg over 3 days, at least 1 hour prior to surgical procedure
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| 0 |
| 57 |
| 29 |
| 57 |
| EG001 | Scopolamine | Oral Aprepitant pill and Scopolamine transdermal patch at least 1 hour prior to surgical procedure. Scopolamine + Emend (Aprepitant): 1.5 mg patch delivering transdermally in vivo approx. 1.0mg over 3 days | 0 | 58 | 34 | 58 |
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| D012602 |
| Scopolamine Derivatives |
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D001533 | Belladonna Alkaloids |
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |