Aprepitant plus palonosetron for the prevention of postoperative nausea and vomiting after breast cancer surgery: a double blind, randomized trial

Autor(es)

Thiago Ramos Grigio ^[1] ; Angela Maria Sousa ; Gabriel Guimarães Nunes Magalhães ^[3] ; Hazem Adel Ashmawi ^[4] ; Joaquim Edson Vieira ^[5]

Afiliação do(s) autor(es)

^[1] Universidade de Sao Paulo. Hospital das Clinicas HCFMUSP, Faculdade de Medicina. Anestesia, Instituto do Cancer do Estado de Sao Paulo (ICESP) - Brasil

^[3] Universidade de Brasilia. Faculdade Medicina. Campus Darcy Ribeiro - Brasil

^[4] Universidade de Sao Paulo. Hospital das Clinicas HCFMUSP, Faculdade de Medicina. Anestesiologia Experimental LIM-08 - Brasil

^[5] Universidade de Sao Paulo. Cirurgia, Faculdade de Medicina FMUSP - Brasil

• Tipo de documento: Artigo Científico
• Fonte: Clinics; v. 75, 2020-09-02.

Resumo

OBJECTIVES: To evaluate the addition of a fourth antiemetic intervention in patients at high risk for postoperative nausea and vomiting (PONV). METHODS: High-risk patients (Apfel score 3 or 4) scheduled for unilateral mastectomy were randomly allocated in one of two groups, oral aprepitant (oral aprepitant 80 mg, intravenous dexamethasone 8 mg, and palonosetron 0.075 mg) and oral placebo (oral placebo, intravenous dexamethasone 4 mg, and palonosetron 0.075 mg). Patients and caregivers were blinded to the group assignments. The primary efficacy endpoints included the incidence of nausea and vomiting, and the secondary endpoints included use of rescue antiemetics during a 48-hour postoperative period. ClinicalTrials.gov: NCT02431286. RESULTS: One hundred patients were enrolled in this study and 91 were analyzed, 48 in group A and 43 in group P. No patient presented with nausea or vomiting in the first 2 hours after surgery. From the 2nd to the 6th hour, the incidence of PONV was 8.33% in group A and 9.30% in group P. In the first 24 hours, the incidence of PONV was 27.08% in the group A and 20.93% in group P. From the 24th to the 48th hour, the incidence of PONV was 8.33% in group A and 13.95% in group P. There were no statistically significant differences in PONV between groups. CONCLUSION: The addition of aprepitant as a third antiemetic resulted in no significant reduction in the incidence of PONV in this population. However, the incidence of PONV was reduced in relation to the general population. (AU)

• Processo FAPESP: 15/00867-0 - Avaliação do efeito da palonasetrona e a associação palonasetrona/aprepitanto na incidência de náuseas e vômitos pós-operatórios em pacientes oncológicas submetidas à mastectomia, de alto risco pela escala de Apfel
• Beneficiário: Liam Eichenberger da Silva Mc Auliffe
• Modalidade de apoio: Bolsas no Brasil - Iniciação Científica
• Processo FAPESP: 12/11298-8 - Avaliação do efeito da palonasetrona e a associação palonasetrona/aprepitanto na incidência de náuseas e vômitos pós-operatórios em pacientes oncológicos de alto risco pela escala de Apfel
• Beneficiário: Angela Maria Sousa
• Modalidade de apoio: Auxílio à Pesquisa - Regular