Palonosetron Associated to Aprepitant in Prophylaxis of PONV

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Evaluation of Palonosetron and Palonosetron/Aprepitant in Post Operative Nausea and Vomiting Incidence in Oncological Patients

Conditions
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Postoperative Nausea and Vomiting

Intervention / Treatment
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* Drug: Aprepitant
* Drug: Placebo
* Drug: Dexamethasone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients submitted to breast cancer surgery non smokers Exclusion Criteria: any contraindication to one of the drugs mental disease inability to understand the method or refusal to participate in the research

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aprepitant<br>patient will receive aprepitant 80 mg per os one hour before surgery; palonosetron and dexamethasone will be intravenously administered during surgery | Drug: Aprepitant<br>* aprepitant will be administered in preoperative period; intravenous palonosetron and dexamethasone will be administered intraoperatively<br>* Other names: Emend;Drug: Dexamethasone<br>* Dexamethasone and plonosetron will be administered intraoperatively in both groups, durong surgery<br>* Other names: Decadron;|
| Placebo Comparator: placebo<br>patient will receive placebo per os one hour before surgery; palonosetron and dexamethasone will be intravenously administered during surgery | Drug: Placebo<br>* Placebo will be administered in the preoperative period; intravenous palonosetron and dexamethasone will be administered intraoperatively<br>* Other names: Saline;Drug: Dexamethasone<br>* Dexamethasone and plonosetron will be administered intraoperatively in both groups, durong surgery<br>* Other names: Decadron;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of postoperative nausea and vomiting | intensity of nausea | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative pain measured by Verbal and descriptive scale | pain intensity in the first 24 hours after surgery | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nausea and vomiting, postoperative, emesis, postoperative