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| ID | Type | Description | Link |
|---|---|---|---|
| Merck #32589 |
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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
| Drexel University College of Medicine | OTHER |
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The combination of aprepitant and lower dose dexamethasone is superior to aprepitant alone with respect to the proportion of patients with a complete response (no vomiting and no use of rescue therapy) during 24 hours after the placement of last suture/staple.
Postoperative Nausea and Vomiting (PONV) is a serious and common (50%-70%) complication of laparoscopic abdominal surgery. PONV is multifactorial, and the treatment is multimodal. Preoperative treatment should target the specific mechanism of PONV to minimize its incidence/consequences to the benefit of the patients.
Aprepitant, a selective antagonist of neurokinin-1 (NK-1) receptors, blocks the emetic effects of substance P.5 Substance P action on the NK-1 receptors in the central nervous system (CNS) is one of the final pathways to an emetic response. Dexamethasone is an inexpensive and effective antiemetic drug with minimal side effects after a single-dose administration. The commonly used minimal effective dose is 8 to 10 mg, but the dose 5 mg is suggested for PONV in patients undergoing laparoscopic surgeries. Based on the literature review, occurrence of PONV does not significantly differ at dosing of Dexamethasone equal or higher than 4 mg.
This 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 and dexamethasone or aprepitant alone preoperatively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Comparator | Active Comparator | Patients receive aprepitant and dexamethasone for prevention of postoperative nausea and vomiting |
|
| Placebo Comparator | Placebo Comparator | Patients receiving aprepitant and placebo dexamethasone for prevention of postoperative nausea and vomiting |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone | Drug | Dexamethasone 5 mg administered intravenously following endotracheal intubation |
|
| Measure | Description | Time Frame |
|---|---|---|
| the incidences of nausea, vomiting, need for rescue medication | 1 hour, 2 hours, 24 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| incidences of unplanned hospital admission; duration of PACU stay | 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dmitri Chamchad, MD | Contact | 610-645-6866 | chamchad@hotmail.com | |
| Mikhail Medved, PhD | Contact | 610-645-6866 | MedvedM@MLHS.ORG |
| Name | Affiliation | Role |
|---|---|---|
| Dmitri Chamchad, MD | Lankenau Hospital, Lankenau Institute for Medical Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lankenau Hospital | Wynnewood | Pennsylvania | 19096 | United States |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Feb 9, 2011 | |
| Reset | Mar 3, 2011 | |
| Release | Jun 16, 2011 |
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| Aprepitant | Drug | Aprepitant 40mg PO one time at least one hour prior to induction of anesthesia |
|
|
| Placebo Dexamethasone | Drug |
|
| Reset | Jul 14, 2011 |
| Release | Jul 20, 2011 |
| Reset | Aug 12, 2011 |
| Release | Jul 3, 2015 |
| Reset | Jul 30, 2015 |
| Release | Sep 30, 2017 |
| Reset | Oct 30, 2017 |
| Release | Aug 14, 2019 |
| Reset | Sep 3, 2019 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 9, 2011 | Mar 3, 2011 | |||
| Jun 16, 2011 | Jul 14, 2011 | |||
| Jul 20, 2011 | Aug 12, 2011 | |||
| Jul 3, 2015 | Jul 30, 2015 | |||
| Sep 30, 2017 | Oct 30, 2017 | |||
| Aug 14, 2019 | Sep 3, 2019 |
| ID | Term |
|---|---|
| D009325 | Nausea |
| D014839 | Vomiting |
| D020250 | Postoperative Nausea and Vomiting |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| D000077608 | Aprepitant |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D009025 | Morpholines |
| D010078 | Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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