Evaluation of palonasetron and palonasetron/aprepitant in the incidence of postoperative nausea and vomiting in the high risk oncological patientes based on the Apfel score

• Grant number: 12/11298-8
• Support Opportunities: Regular Research Grants
• Duration: September 01, 2012 - August 31, 2015
• Field of knowledge: Health Sciences - Medicine
• Principal Investigator: Angela Maria Sousa
• Grantee: Angela Maria Sousa
• Host Institution: Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira (ICESP). Coordenadoria de Serviços de Saúde (CSS). Secretaria da Saúde (São Paulo - Estado). São Paulo , SP, Brazil
• Associated researchers: Danielli Boer Costa ; Hazem Adel Ashmawi ; Maria José Carvalho Carmona

Abstract

The incidence of nausea and vomiting after surgery is still significant, ranging from 20 to 50% in outpatient surgery and 70% in some surgical groups. Antiemetics with different mechanisms of action, used for preventing nausea after chemotherapy, has been proposed to treat nausea and vomiting after surgery. Aprepitant, a neurokinin inhibitor and palonasetron, blocking 5HT-3 receptors, are included in the category of antiemetics. This study aimed to prospectively evaluate patients of both genders, admitted to undergo laparoscopic oncologic surgery. We propose a double blind, randomized, controlled study in patients classified with a Apfel score 3 or 4. Patients will be divided into four groups who will receive one tablet the day before surgery, an injection in the operating room and an intravenous injection after surgery:Group 1: 4 mg ondansetron combined with dexamethasone 4 mg IV in the OR + placebo orally before surgery (control); Group 2: palonasetron 0.075 mg combined with dexamethasone 4 mg IV in the OR + placebo orally before surgery;Group 2: palonasetron 0.075 mg combined with dexamethasone 4 mg IV in the OR + aprepitant 10 mg pre-operatively.Group 4: 4 mg ondansetron combined with dexamethasone 4 mg IV in the OR + aprepitant 10 mg pre-operatively.All patients receive general anesthesia with midazolam 0.1 mg / kg fentanyl 2-5 mg / kg, propofol 2-3 mg / kg and cisatracurium 0.3 mg / kg. Maintenance of anesthesia will be made with an infusion of propofol and remifentanil to maintain BIS between 50 and 60 and AP + or - 30% of preoperative values. At surgery, one of the above solutions will be injected IV. A patient controlled analgesia system is installed In the PACU with a morphine solution of 1 mg / ml. Pain and adverse effects are recorded. In the presence of PONV, a rescue droperidol 0625 mg is intravenouysly injected IV. Number of episodes of vomiting and nausea intensity will be recorded by a visual analog and descriptive scale up to 24 h of surgery. (AU)

Scientific publications

(References retrieved automatically from Web of Science and SciELO through information on FAPESP grants and their corresponding numbers as mentioned in the publications by the authors)

THIAGO RAMOS GRIGIO; ANGELA MARIA SOUSA; GABRIEL GUIMARÃES NUNES MAGALHÃES; HAZEM ADEL ASHMAWI; JOAQUIM EDSON VIEIRA. Aprepitant plus palonosetron for the prevention of postoperative nausea and vomiting after breast cancer surgery: a double blind, randomized trial. Clinics, v. 75, 2020-09-02. (15/00867-0, 12/11298-8)

DE MORAIS, L. C.; SOUSA, A. M.; FLORA, G. F.; GRIGIO, T. R.; GUIMARAES, G. M. N.; ASHMAWI, H. A.. Aprepitant as a fourth antiemetic prophylactic strategy in high-risk patients: a double-blind, randomized trial. ACTA ANAESTHESIOLOGICA SCANDINAVICA, v. 62, n. 4, p. 483-492, APR 2018. (12/11298-8)