Palonosetron Associated to Aprepitant in Prophylaxis of PONV

Instituto do Cancer do Estado de São Paulo

Status and phase: Unknown; Phase 4

Conditions: Postoperative Nausea and Vomiting

Treatments: Drug: Placebo; Drug: Aprepitant; Drug: Dexamethasone

Study type: Interventional

Funder types: Other

Identifiers

NCT02431286

2012/11298-8 (Other Grant/Funding Number)

NP297/12

Details and patient eligibility

About

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.

Full 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

Enrollment: 90 estimated patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 2 patient groups, including a placebo group

Aprepitant

Experimental group

Description:

patient will receive aprepitant 80 mg per os one hour before surgery; palonosetron and dexamethasone will be intravenously administered during surgery

Treatment:

Drug: Dexamethasone

Drug: Aprepitant

placebo

Placebo Comparator group

Description:

patient will receive placebo per os one hour before surgery; palonosetron and dexamethasone will be intravenously administered during surgery

Treatment:

Drug: Dexamethasone

Drug: Placebo