Clinical trial NCT02431286: Palonosetron Associated to Aprepitant in Prophylaxis of PONV
Official title: Evaluation of Palonosetron and Palonosetron/Aprepitant in Post Operative Nausea and Vomiting Incidence in Oncological Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Postoperative Nausea and Vomiting
Keywords: nausea and vomiting, postoperative
emesis, postoperative
Lead sponsor: Instituto do Cancer do Estado de São Paulo
Sponsor class: OTHER
First posted: 2015-05-01
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

Eligibility criteria: 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

Primary outcomes:
measure: incidence of postoperative nausea and vomiting
timeFrame: 24 hours
Secondary outcomes:
measure: postoperative pain measured by Verbal and descriptive scale
timeFrame: 24 hours
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Angela Maria Sousa
state: São Paulo
Study officials:
affiliation: University of Sao Paulo
name: Hazem a Ashmawi, phD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.