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| ID | Type | Description | Link |
|---|---|---|---|
| 2012/11298-8 | Other Grant/Funding Number | FAPESP |
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The objective of this study is to investigate if aprepitant in association with palonosetron and dexamethasone could reduce the incidence of PONV in high-risk patients for this symptom, undergoing cancer surgery mastectomies.
Postoperative nausea and vomiting (PONV) is a common anesthetic complication that occurs in approximately 30% of the surgical population and can reach up to 70% in high risk patients for PONV. Advances have been made to prevent PONV, but the incidence is still high in certain groups of patients. In high risk patients, pharmacologic intervention should consist of multimodal therapy, targeting different mechanisms of action. The objective of this study is to investigate if aprepitant in association with palonosetron and dexamethasone could reduce the incidence of PONV in high-risk patients for this symptom, undergoing cancer surgery mastectomies. METHODS: this is a randomized and double blind clinical trial. Female high-risk patients for PONV(Apfel score 3 or 4) scheduled for mastectomy that agree with the study and signed the informed consent, are randomly distributed into one of two groups: Group A, aprepitant 80 mg per os one hour before the surgery and Group B will receive placebo by the same route one hour before surgery, in a blinded way. After induction of anesthesia, dexamethasone 4 mg and palonosetron 0,075mg are intravenously administered to all patients. After the end of the surgery, a patient-controlled analgesia (PCA) device will be intravenously inserted in all patients. In the postoperative period, patients will be evaluated for nausea, vomiting and pain intensity in the recovery room and after 24 hours
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aprepitant | Experimental | patient will receive aprepitant 80 mg per os one hour before surgery; palonosetron and dexamethasone will be intravenously administered during surgery |
|
| placebo | Placebo Comparator | patient will receive placebo per os one hour before surgery; palonosetron and dexamethasone will be intravenously administered during surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aprepitant | Drug | aprepitant will be administered in preoperative period; intravenous palonosetron and dexamethasone will be administered intraoperatively |
|
| Measure | Description | Time Frame |
|---|---|---|
| incidence of postoperative nausea and vomiting | intensity of nausea | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| postoperative pain measured by Verbal and descriptive scale | pain intensity in the first 24 hours after surgery | 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Angela Sousa, phD | Contact | 551126616680 | angela.sousa@icesp.org.br |
| Name | Affiliation | Role |
|---|---|---|
| Hazem a Ashmawi, phD | University of Sao Paulo | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Angela Maria Sousa | Recruiting | São Paulo | São Paulo | 01403010 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25165427 | Result | Moon HY, Baek CW, Choi GJ, Shin HY, Kang H, Jung YH, Woo YC, Kim JY, Park SG. Palonosetron and aprepitant for the prevention of postoperative nausea and vomiting in patients indicated for laparoscopic gynaecologic surgery: a double-blind randomised trial. BMC Anesthesiol. 2014 Aug 10;14:68. doi: 10.1186/1471-2253-14-68. eCollection 2014. | |
| 20871394 |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jan 16, 2018 | |
| Reset | Sep 21, 2018 | |
| Release | May 14, 2021 | |
| Reset | Jun 8, 2021 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 16, 2018 | Sep 21, 2018 | |||
| May 14, 2021 |
| 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 |
|---|---|
| D000077608 | Aprepitant |
| D012965 | Sodium Chloride |
| D003907 | Dexamethasone |
| D002123 | Calcium Dobesilate |
| ID | Term |
|---|---|
| D009025 | Morpholines |
| D010078 | Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
| Placebo | Drug | Placebo will be administered in the preoperative period; intravenous palonosetron and dexamethasone will be administered intraoperatively |
|
|
| Dexamethasone | Drug | Dexamethasone and plonosetron will be administered intraoperatively in both groups, durong surgery |
|
|
| George E, Hornuss C, Apfel CC. Neurokinin-1 and novel serotonin antagonists for postoperative and postdischarge nausea and vomiting. Curr Opin Anaesthesiol. 2010 Dec;23(6):714-21. doi: 10.1097/ACO.0b013e32833f9f7b. |
| 32901672 | Derived | Grigio TR, Sousa AM, Magalhaes GGN, Ashmawi HA, Vieira JE. Aprepitant plus palonosetron for the prevention of postoperative nausea and vomiting after breast cancer surgery: a double blind, randomized trial. Clinics (Sao Paulo). 2020;75:e1688. doi: 10.6061/clinics/2020/e1688. Epub 2020 Sep 2. |
| Jun 8, 2021 |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D014839 | Vomiting |
| D002712 |
| Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D001557 | Benzenesulfonates |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D001190 | Arylsulfonates |
| D017739 | Arylsulfonic Acids |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |