Brazilian Journal of Anesthesiology
https://bjan-sba.org/article/doi/10.1016/j.bjane.2021.07.027
Brazilian Journal of Anesthesiology
Original Investigation

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

Downloads: 0
Views: 596

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

End-stage renal disease (ESRD);  Postoperative nausea and vomiting (PONV);  Palonosetron;  Ondansetron;  PONV intensity scale;  Renal transplant recipients

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

Doença renal terminal (DRT); Náuseas e vômitos pós-operatórios (NVPO); Palonossetrona; Ondansetrona; Escala de intensidade de NVPO; Receptores de transplante renal

References

1. Kumar A, Solanki S, Gangakhedkar G, et al. Comparison of Palonosetron and dexamethasone with Ondansetron and dexamethasone for postoperative nausea and vomiting in postchemotherapy ovarian cancer surgeries requiring opioidbased patient-controlled analgesia: a randomized, doubleblind, active-controlled study. Indian J Anaesth. 2018;62:773–9.

2. Santacoloma Osorio M, Camilo Giraldo G. Manifestaciones gastrointestinales de la enfermedad renal crónica. Rev Colomb Nefrol. 2017;4:17.

3. Salles Junior LD, Santos PR, Dos Santos AA, et al. Dyspepsia and gastric emptying in end-stage renal disease patients on hemodialysis. BMC Nephrol. 2013;14:275.

4. Chatterjee A, Sahu S, Paul M, et al. Comparison of the efficacy of Palonosetron-dexamethasone combination with Palonosetron or dexamethasone alone for prophylaxis against postoperative nausea and vomiting in patients undergoing laparoscopic cholecystectomy. Indian J Anaesth. 2017;61:978–84.

5. Thomas AG, Stathis M, Rojas C, et al. Netupitant and Palonosetron trigger NK1 receptor internalization in NG108- 15 cells. Exp Brain Res; 2014. p. 2637–44, http://dx.doi.org/ 10.1007/s00221-014-4017-7.

6. Singh PM, Borle A, Gouda D, et al. Efficacy of Palonosetron in postoperative nausea and vomiting (PONV) – a meta-analysis. J Clin Anesth. 2016;34:459–82.

7. Xiong C, Liu G, Ma R, et al. Efficacité du palonosétron pour la prévention des nausées et vomissements postopératoires: une revue systématique de la littérature et méta-analyse. Can J Anesth. 2015;62:1268–78.

8. Chun HR, Jeon IS, Park SY, et al. Efficacy of Palonosetron for the prevention of postoperative nausea and vomiting: a randomized, double-blinded, placebo-controlled trial. Br J Anaesth. 2014;112:485–90.

9. Gralla R, Lichinitser M, Van Der Vegt S, et al. Palonosetron improves prevention of chemotherapy-induced nausea and vomiting following moderately emetogenic chemotherapy: results of a double-blind randomized phase III trial comparing single doses of Palonosetron with Ondansetron. Ann Oncol. 2003;14:1570–7.

10. Wengritzky R, Mettho T, Myles PS, et al. Development and validation of a postoperative nausea and vomiting intensity scale. Br J Anaesth. 2010;104:158–66.

11. Cano AE, Neil AK, Kang J-Y, et al. Gastrointestinal symptoms in patients with end-stage renal disease undergoing treatment by hemodialysis or peritoneal dialysis. Am J Gastroenterol. 2007;102:1990–7.

12. Helderman JH, Goral S. Gastrointestinal complications of transplant immunosuppression. J Am Soc Nephrol. 2002;13:277–87.

13. Apfel CC, Korttila K, Abdalla M, et al. IMPACT Investigators. A factorial trial of six interventions for the prevention of postoperative nausea and vomiting. N Engl J Med. 2004;350:2441–51.

14. Gan TJ, Belani KG, Bergese S, et al. Fourth consensus guidelines for the management of postoperative nausea and vomiting. Anesth Analg. 2020;131:411–48.

15. Kovac AL, Eberhart L, Kotarski J, et al. A randomized, doubleblind study to evaluate the efficacy and safety of three different doses of Palonosetron versus placebo in preventing postoperative nausea and vomiting over a 72-hour period. Anesth Analg. 2008;107:439–44.

16. Candiotti KA, Kovac AL, Melson TI, et al. A randomized, doubleblind study to evaluate the efficacy and safety of three different doses of Palonosetron versus placebo for preventing postoperative nausea and vomiting. Anesth Analg. 2008;107:445–51.

17. Dalila V, Pereira H, Moreno C, et al. Postoperative nausea and vomiting: validation of the Portuguese version of the postoperative nausea and vomiting intensity score. Braz J Anesthesiol. 2013;63:340–6.


Submitted date:
10/04/2020

Accepted date:
07/24/2021

611feba5a95395736a738253 rba Articles
Links & Downloads

Braz J Anesthesiol

Share this page
Page Sections