Palonosetron Associated to Aprepitant in Prophylaxis of PONV

Phase 4

• Conditions: Postoperative Nausea and Vomiting
• Interventions: Drug: Placebo; Drug: Aprepitant; Drug: Dexamethasone

• Registration Number: NCT02431286
• Lead Sponsor: Instituto do Cancer do Estado de São Paulo

Brief Summary

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

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

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2015-01-31
• Status Verified: 2015-04
• Study First Submitted QC: 2015-04-30
• Last Update Submitted: 2015-04-30
• Study First Posted: 2015-05-01
• Last Update Posted: 2015-05-01
• Primary Completion: 2015-12
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aprepitant	Dexamethasone	patient will receive aprepitant 80 mg per os one hour before surgery; palonosetron and dexamethasone will be intravenously administered during surgery
placebo	Placebo	patient will receive placebo per os one hour before surgery; palonosetron and dexamethasone will be intravenously administered during surgery
Aprepitant	Aprepitant	patient will receive aprepitant 80 mg per os one hour before surgery; palonosetron and dexamethasone will be intravenously administered during surgery
placebo	Dexamethasone	patient will receive placebo per os one hour before surgery; palonosetron and dexamethasone will be intravenously administered during surgery

Primary Outcome Measures

Name	Time	Method
incidence of postoperative nausea and vomiting	24 hours	intensity of nausea

Secondary Outcome Measures

Name	Time	Method
postoperative pain measured by Verbal and descriptive scale	24 hours	pain intensity in the first 24 hours after surgery

Trial Locations

Locations (1)

Angela Maria Sousa; 🇧🇷 Sao Paulo, São Paulo, Brazil