Comparison of palonosetron and ondansetron in preventing postoperative nausea and vomiting in renal transplant recipients: a randomized clinical trial
Comparação de palonosetrona e ondansetrona na prevenção de náuseas e vômitos pós-operatórios em receptores de transplante renal: um ensaio clínico randomizado
Bhargava Tanvi; Sandeep Sahu; Tapas Kumar Singh; Divya Shrivastava; Abhishek Kumar; Mohammad Danish; Aneesh Srivastava
Abstract
Background
End-stage renal diseases patients have a high risk of postoperative nausea and vomiting (PONV), which is multifactorial and need acute attention after renal transplantation for a successful outcome in term of an uneventful postoperative period. The study was done to compare the efficacy of palonosetron and ondansetron in preventing early and late-onset PONV in live donor renal transplantation recipients (LDRT).
Methods
The prospective randomized double-blinded study was done on 112 consecutive patients planned for live donor renal transplantation. Patients of both sexes in the age group of 18–60 years were randomly divided into two groups: Group-O (Ondansetron) and Group-P (Palonosetron) with 56 patients in each group by computer-generated randomization. The study drug was administered intravenously (IV) slowly over 30 s, one hour before extubation. Postoperatively, the patients were accessed for PONV at 6, 24, and 72 hours using the Visual Analogue Scale (VAS) nausea score and PONV intensity scale.
Results
The incidence of PONV in the study was found to be 30.35%. There was significant difference in incidence of PONV between Group-P and Group-O at 6 hours (12.5% vs 32.1%, p = 0.013) and 72 hours (1.8% vs. 33.9%, p < 0.001), but insignificant difference at 24 hours (1.8% vs. 10.7%, p = 0.113). VAS-nausea score was significantly lower in Group-P as compared to Group-O at a time point of 24 hours (45.54 ± 12.64 vs. 51.96 ± 14.70, p = 0.015) and 72 hours (39.11 ± 10.32 vs. 45.7 ± 15.12, p = 0.015).
Conclusion
Palonosetron is clinically superior to ondansetron in preventing early and delayed onset postoperative nausea and vomiting in live-related renal transplant recipients.
Keywords
Resumo
Introdução
Pacientes com doenças renais em estágio terminal apresentam alto risco de náuseas e vômitos pós-operatórios (NVPO), que é multifatorial e necessita de atenção aguda após o transplante renal para um resultado bem-sucedido em termos de um período pós-operatório sem intercorrências. O estudo foi realizado para comparar a eficácia da palonosetrona e da ondansetrona na prevenção de NVPO de início precoce e tardio em receptores de transplante renal de doador vivo (TRDV).
Métodos
O estudo prospectivo randomizado duplo-cego foi realizado em 112 pacientes consecutivos planejados para transplante renal de doador vivo. Pacientes de ambos os sexos na faixa etária de 18 a 60 anos foram divididos aleatoriamente em dois grupos: Grupo O (Ondansetrona) e Grupo P (Palonosetrona) com 56 pacientes em cada grupo por randomização gerada por computador. O medicamento do estudo foi administrado por via intravenosa (IV) lentamente durante 30 segundos, uma hora antes da extubação. No pós-operatório, os pacientes foram avaliados para NVPO em 6, 24 e 72 horas usando o escore de náusea da Escala Visual Analógica (EVA) e a escala de intensidade de NVPO.
Resultados
A incidência de NVPO no estudo foi de 30,35%. Houve diferença significativa na incidência de NVPO entre o Grupo P e o Grupo O às 6 horas (12,5% vs. 32,1%, p = 0,013) e 72 horas (1,8% vs. 33,9%, p < 0,001), mas diferença insignificante às 24 horas. horas (1,8% vs. 10,7%, p = 0,113). A pontuação EVA-náusea foi significativamente menor no Grupo P em comparação ao Grupo O nos momentos de 24 horas (45,54 ± 12,64 vs. 51,96 ± 14,70, p = 0,015) e 72 horas (39,11 ± 10,32 vs. 45,7 ± 15,12, p = 0,015).
Conclusão
A palonosetrona é clinicamente superior à ondansetrona na prevenção de náuseas e vômitos pós-operatórios precoces e tardios em receptores de transplante renal vivos.
Palavras-chave
References
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Submitted date:
10/04/2020
Accepted date:
07/24/2021
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