Skip to main content
Top
Published in: Journal of Anesthesia 6/2016

01-12-2016 | Original Article

A randomized, double-blind trial evaluating the efficacy of palonosetron with total intravenous anesthesia using propofol and remifentanil for the prevention of postoperative nausea and vomiting after gynecologic surgery

Authors: Yun-Sic Bang, Young Uk Kim, Dawoon Oh, Eui Yong Shin, Soo Kyoung Park

Published in: Journal of Anesthesia | Issue 6/2016

Login to get access

Abstract

Purpose

Palonosetron has potent and long-acting antiemetic effects for postoperative nausea and vomiting (PONV). The aim of this study was to prospectively evaluate the efficacy of palonosetron when used with total intravenous anesthesia (TIVA) using propofol and remifentanil for the prevention of PONV in patients undergoing laparoscopic gynecologic surgery.

Methods

This prospective double-blind study comprised 100 female American Society of Anesthesiologist physical status I and II patients who were undergoing laparoscopic gynecologic surgery under TIVA. The patients were randomly assigned to two groups—the palonosetron plus TIVA group (palonosetron 0.075 mg i.v., n = 50) and the TIVA group (normal saline 1.5 ml i.v., n = 50). The treatments were given before the induction of anesthesia. The incidence of PONV, severity, number of rescue antiemetics, adverse effects, and patient satisfaction during the first 24 h after surgery were evaluated.

Results

The demographic profiles of the patients in the two groups were comparable. The overall incidence of PONV (0–24 h) was significantly lower in the TIVA plus palonosetron group than in the TIVA group (34 vs 58 %, p = 0.027). In particular, during the 6–24 h after surgery, the incidence of PONV (14 vs 30 %, p = 0.03) and the incidence of moderate to severe nausea (6 vs 22 %, p = 0.041) were significantly lower in the TIVA plus palonosetron group than in the TIVA group. There were no significant differences in adverse effects, use of rescue antiemetics or patient satisfaction.

Conclusion

Combining palonosetron with TIVA can be considered as a good method to prevent PONV, not only during the short postoperative period but also especially during the 6–24-h period after anesthesia.
Literature
1.
go back to reference Muchatuta NA, Paech MJ. Management of postoperative nausea and vomiting: focus on palonosetron. Ther Clin Risk Manag. 2009;5:21–34.PubMedPubMedCentral Muchatuta NA, Paech MJ. Management of postoperative nausea and vomiting: focus on palonosetron. Ther Clin Risk Manag. 2009;5:21–34.PubMedPubMedCentral
2.
go back to reference Apfel CC, Laara E, Koivuranta M, Greim CA, Roewer N. A simplified risk score for predicting postoperative nausea and vomiting: conclusions from cross-validations between two centers. Anesthesiology. 1999;91:693–700.CrossRefPubMed Apfel CC, Laara E, Koivuranta M, Greim CA, Roewer N. A simplified risk score for predicting postoperative nausea and vomiting: conclusions from cross-validations between two centers. Anesthesiology. 1999;91:693–700.CrossRefPubMed
4.
go back to reference Ho KY, Gan TJ. Pharmacology, pharmacogenetics, and clinical efficacy of 5-hydroxytryptamine type 3 receptor antagonists for postoperative nausea and vomiting. Curr Opin Anaesthesiol. 2006;19:606–11.CrossRefPubMed Ho KY, Gan TJ. Pharmacology, pharmacogenetics, and clinical efficacy of 5-hydroxytryptamine type 3 receptor antagonists for postoperative nausea and vomiting. Curr Opin Anaesthesiol. 2006;19:606–11.CrossRefPubMed
5.
go back to reference Xiong C, Liu G, Ma R, Xue J, Wu A. Efficacy of palonosetron for preventing postoperative nausea and vomiting: a systematic review and meta-analysis. Can J Anaesth. 2015;62:1268–78.CrossRefPubMed Xiong C, Liu G, Ma R, Xue J, Wu A. Efficacy of palonosetron for preventing postoperative nausea and vomiting: a systematic review and meta-analysis. Can J Anaesth. 2015;62:1268–78.CrossRefPubMed
6.
go back to reference Stoltz R, Cyong JC, Shah A, Parisi S. Pharmacokinetic and safety evaluation of palonosetron, a 5-hydroxytryptamine-3 receptor antagonist, in U.S. and Japanese healthy subjects. J Clin Pharmacol. 2004;44:520–31.CrossRefPubMed Stoltz R, Cyong JC, Shah A, Parisi S. Pharmacokinetic and safety evaluation of palonosetron, a 5-hydroxytryptamine-3 receptor antagonist, in U.S. and Japanese healthy subjects. J Clin Pharmacol. 2004;44:520–31.CrossRefPubMed
7.
go back to reference Wong EH, Clark R, Leung E, Loury D, Bonhaus DW, Jakeman L, Parnes H, Whiting RL, Eglen RM. The interaction of RS 25259-197, a potent and selective antagonist, with 5-HT3 receptors, in vitro. Br J Pharmacol. 1995;114:851–9.CrossRefPubMedPubMedCentral Wong EH, Clark R, Leung E, Loury D, Bonhaus DW, Jakeman L, Parnes H, Whiting RL, Eglen RM. The interaction of RS 25259-197, a potent and selective antagonist, with 5-HT3 receptors, in vitro. Br J Pharmacol. 1995;114:851–9.CrossRefPubMedPubMedCentral
8.
go back to reference White H, Black RJ, Jones M. Mar Fan GC. Randomized comparison of two anti-emetic strategies in high-risk patients undergoing day-case gynaecological surgery. Br J Anaesth. 2007;98:470–6.CrossRefPubMed White H, Black RJ, Jones M. Mar Fan GC. Randomized comparison of two anti-emetic strategies in high-risk patients undergoing day-case gynaecological surgery. Br J Anaesth. 2007;98:470–6.CrossRefPubMed
9.
go back to reference Watcha MF, White PF. Postoperative nausea and vomiting. Its etiology, treatment, and prevention. Anesthesiology. 1992;77:162–84.CrossRefPubMed Watcha MF, White PF. Postoperative nausea and vomiting. Its etiology, treatment, and prevention. Anesthesiology. 1992;77:162–84.CrossRefPubMed
10.
go back to reference Choi DK, Chin JH, Lee EH, Lim OB, Chung CH, Ro YJ, Choi IC. Prophylactic control of post-operative nausea and vomiting using ondansetron and ramosetron after cardiac surgery. Acta Anaesthesiol Scand. 2010;54:962–9.CrossRefPubMed Choi DK, Chin JH, Lee EH, Lim OB, Chung CH, Ro YJ, Choi IC. Prophylactic control of post-operative nausea and vomiting using ondansetron and ramosetron after cardiac surgery. Acta Anaesthesiol Scand. 2010;54:962–9.CrossRefPubMed
11.
go back to reference Park SK, Cho EJ. A randomized, double-blind trial of palonosetron compared with ondansetron in preventing postoperative nausea and vomiting after gynaecological laparoscopic surgery. J Int Med Res. 2011;39:399–407.CrossRefPubMed Park SK, Cho EJ. A randomized, double-blind trial of palonosetron compared with ondansetron in preventing postoperative nausea and vomiting after gynaecological laparoscopic surgery. J Int Med Res. 2011;39:399–407.CrossRefPubMed
12.
go back to reference Apfel CC, Korttila K, Abdalla M, Kerger H, Turan A, Vedder I, Zernak C, Danner K, Jokela R, Pocock SJ, Trenkler S, Kredel M, Biedler A, Sessler DI, Roewer N. A factorial trial of six interventions for the prevention of postoperative nausea and vomiting. N Engl J Med. 2004;350:2441–51.CrossRefPubMedPubMedCentral Apfel CC, Korttila K, Abdalla M, Kerger H, Turan A, Vedder I, Zernak C, Danner K, Jokela R, Pocock SJ, Trenkler S, Kredel M, Biedler A, Sessler DI, Roewer N. A factorial trial of six interventions for the prevention of postoperative nausea and vomiting. N Engl J Med. 2004;350:2441–51.CrossRefPubMedPubMedCentral
13.
go back to reference Jokela RM, Cakmakkaya OS, Danzeisen O, Korttila KT, Kranke P, Malhotra A, Paura A, Radke OC, Sessler DI, Soikkeli A, Roewer N, Apfel CC. Ondansetron has similar clinical efficacy against both nausea and vomiting. Anaesthesia. 2009;64:147–51.CrossRefPubMed Jokela RM, Cakmakkaya OS, Danzeisen O, Korttila KT, Kranke P, Malhotra A, Paura A, Radke OC, Sessler DI, Soikkeli A, Roewer N, Apfel CC. Ondansetron has similar clinical efficacy against both nausea and vomiting. Anaesthesia. 2009;64:147–51.CrossRefPubMed
14.
go back to reference Rojas C, Li Y, Zhang J, Stathis M, Alt J, Thomas AG, Cantoreggi S, Sebastiani S, Pietra C, Slusher BS. The antiemetic 5-HT3 receptor antagonist palonosetron inhibits substance P-mediated responses in vitro and in vivo. J Pharmacol Exp Ther. 2010;335:362–8.CrossRefPubMedPubMedCentral Rojas C, Li Y, Zhang J, Stathis M, Alt J, Thomas AG, Cantoreggi S, Sebastiani S, Pietra C, Slusher BS. The antiemetic 5-HT3 receptor antagonist palonosetron inhibits substance P-mediated responses in vitro and in vivo. J Pharmacol Exp Ther. 2010;335:362–8.CrossRefPubMedPubMedCentral
15.
go back to reference Rojas C, Thomas AG, Alt J, Stathis M, Zhang J, Rubenstein EB, Sebastiani S, Cantoreggi S, Slusher BS. Palonosetron triggers 5-HT(3) receptor internalization and causes prolonged inhibition of receptor function. Eur J Pharmacol. 2010;626:193–9.CrossRefPubMed Rojas C, Thomas AG, Alt J, Stathis M, Zhang J, Rubenstein EB, Sebastiani S, Cantoreggi S, Slusher BS. Palonosetron triggers 5-HT(3) receptor internalization and causes prolonged inhibition of receptor function. Eur J Pharmacol. 2010;626:193–9.CrossRefPubMed
16.
go back to reference Kim HJ, Lee HC, Jung YS, Lee J, Min JJ, Hong DM, Choi EK, Oh S, Jeon Y. Effect of palonosetron on the QTc interval in patients undergoing sevoflurane anaesthesia. Br J Anaesth. 2014;112:460–8.CrossRefPubMed Kim HJ, Lee HC, Jung YS, Lee J, Min JJ, Hong DM, Choi EK, Oh S, Jeon Y. Effect of palonosetron on the QTc interval in patients undergoing sevoflurane anaesthesia. Br J Anaesth. 2014;112:460–8.CrossRefPubMed
17.
go back to reference Candiotti KA, Kovac AL, Melson TI, Clerici G, Joo Gan T. A randomized, double-blind 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.CrossRefPubMed Candiotti KA, Kovac AL, Melson TI, Clerici G, Joo Gan T. A randomized, double-blind 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.CrossRefPubMed
18.
go back to reference Kovac AL, Eberhart L, Kotarski J, Clerici G, Apfel C. A randomized, double-blind study to evaluate the efficacy and safety of three different doses of palonosetron versus placebo in preventing postoperative nausea and vomiting over a 72 h period. Anesth Analg. 2008;107:439–44.CrossRefPubMed Kovac AL, Eberhart L, Kotarski J, Clerici G, Apfel C. A randomized, double-blind study to evaluate the efficacy and safety of three different doses of palonosetron versus placebo in preventing postoperative nausea and vomiting over a 72 h period. Anesth Analg. 2008;107:439–44.CrossRefPubMed
19.
go back to reference Apfel CC, Kranke P, Katz MH, Goepfert C, Papenfuss T, Rauch S, Heineck R, Greim CA, Roewer N. Volatile anaesthetics may be the main cause of early but not delayed postoperative vomiting: a randomized controlled trial of factorial design. Br J Anaesth. 2002;88:659–68.CrossRefPubMed Apfel CC, Kranke P, Katz MH, Goepfert C, Papenfuss T, Rauch S, Heineck R, Greim CA, Roewer N. Volatile anaesthetics may be the main cause of early but not delayed postoperative vomiting: a randomized controlled trial of factorial design. Br J Anaesth. 2002;88:659–68.CrossRefPubMed
20.
go back to reference Sneyd JR, Carr A, Byrom WD, Bilski AJ. A meta-analysis of nausea and vomiting following maintenance of anaesthesia with propofol or inhalational agents. Eur J Anaesthesiol. 1998;15:433–45.CrossRefPubMed Sneyd JR, Carr A, Byrom WD, Bilski AJ. A meta-analysis of nausea and vomiting following maintenance of anaesthesia with propofol or inhalational agents. Eur J Anaesthesiol. 1998;15:433–45.CrossRefPubMed
21.
go back to reference Tramer M, Moore A, McQuay H. Propofol anaesthesia and postoperative nausea and vomiting: quantitative systematic review of randomized controlled studies. Br J Anaesth. 1997;78:247–55.CrossRefPubMed Tramer M, Moore A, McQuay H. Propofol anaesthesia and postoperative nausea and vomiting: quantitative systematic review of randomized controlled studies. Br J Anaesth. 1997;78:247–55.CrossRefPubMed
22.
go back to reference Tricco AC, Soobiah C, Blondal E, Veroniki AA, Khan PA, Vafaei A, Ivory J, Strifler L, Ashoor H, MacDonald H, Reynen E, Robson R, Ho J, Ng C, Antony J, Mrklas K, Hutton B, Hemmelgarn BR, Moher D, Straus SE. Comparative efficacy of serotonin (5-HT3) receptor antagonists in patients undergoing surgery: a systematic review and network meta-analysis. BMC Med. 2015;13:136.CrossRefPubMedPubMedCentral Tricco AC, Soobiah C, Blondal E, Veroniki AA, Khan PA, Vafaei A, Ivory J, Strifler L, Ashoor H, MacDonald H, Reynen E, Robson R, Ho J, Ng C, Antony J, Mrklas K, Hutton B, Hemmelgarn BR, Moher D, Straus SE. Comparative efficacy of serotonin (5-HT3) receptor antagonists in patients undergoing surgery: a systematic review and network meta-analysis. BMC Med. 2015;13:136.CrossRefPubMedPubMedCentral
23.
go back to reference Lee WS, Lee KB, Lim S, Chang YG. Comparison of palonosetron, granisetron, and ramosetron for the prevention of postoperative nausea and vomiting after laparoscopic gynecologic surgery: a prospective randomized trial. BMC Anesthesiol. 2015;15:121.CrossRefPubMedPubMedCentral Lee WS, Lee KB, Lim S, Chang YG. Comparison of palonosetron, granisetron, and ramosetron for the prevention of postoperative nausea and vomiting after laparoscopic gynecologic surgery: a prospective randomized trial. BMC Anesthesiol. 2015;15:121.CrossRefPubMedPubMedCentral
24.
go back to reference Scuderi PE, James RL, Harris L, Mims GR 3rd. Multimodal antiemetic management prevents early postoperative vomiting after outpatient laparoscopy. Anesth Analg. 2000;91:1408–14.CrossRefPubMed Scuderi PE, James RL, Harris L, Mims GR 3rd. Multimodal antiemetic management prevents early postoperative vomiting after outpatient laparoscopy. Anesth Analg. 2000;91:1408–14.CrossRefPubMed
25.
go back to reference Leslie JB, Gan TJ. Meta-analysis of the safety of 5-HT3 antagonists with dexamethasone or droperidol for prevention of PONV. Ann Pharmacother. 2006;40:856–72.CrossRefPubMed Leslie JB, Gan TJ. Meta-analysis of the safety of 5-HT3 antagonists with dexamethasone or droperidol for prevention of PONV. Ann Pharmacother. 2006;40:856–72.CrossRefPubMed
26.
go back to reference Apfel CC, Roewer N, Korttila K. How to study postoperative nausea and vomiting. Acta Anaesthesiol Scand. 2002;46:921–8.CrossRefPubMed Apfel CC, Roewer N, Korttila K. How to study postoperative nausea and vomiting. Acta Anaesthesiol Scand. 2002;46:921–8.CrossRefPubMed
27.
go back to reference Breivik EK, Bjornsson GA, Skovlund E. A comparison of pain rating scales by sampling from clinical trial data. Clin J Pain. 2000;16:22–8.CrossRefPubMed Breivik EK, Bjornsson GA, Skovlund E. A comparison of pain rating scales by sampling from clinical trial data. Clin J Pain. 2000;16:22–8.CrossRefPubMed
Metadata
Title
A randomized, double-blind trial evaluating the efficacy of palonosetron with total intravenous anesthesia using propofol and remifentanil for the prevention of postoperative nausea and vomiting after gynecologic surgery
Authors
Yun-Sic Bang
Young Uk Kim
Dawoon Oh
Eui Yong Shin
Soo Kyoung Park
Publication date
01-12-2016
Publisher
Springer Japan
Published in
Journal of Anesthesia / Issue 6/2016
Print ISSN: 0913-8668
Electronic ISSN: 1438-8359
DOI
https://doi.org/10.1007/s00540-016-2249-3

Other articles of this Issue 6/2016

Journal of Anesthesia 6/2016 Go to the issue