Comparison of palonosetron and dexamethasone with ondansetron and dexamethasone for postoperative nausea and vomiting in postchemotherapy ovarian cancer surgeries requiring opioid-based patient-controlled analgesia: A randomised, double-blind, active controlled study

Amit Kumar, Sohan Lal Solanki, Gauri Raman Gangakhedkar, T S Shylasree, Kailash S Sharma, Amit Kumar, Sohan Lal Solanki, Gauri Raman Gangakhedkar, T S Shylasree, Kailash S Sharma

Abstract

Background and aims: Patients undergoing ovarian cancer surgery after chemotherapy and requiring opioid-based patient-controlled analgesia (PCA) are at high-risk of postoperative nausea and vomiting (PONV). We aimed to assess the effect of palonosetron and dexamethasone combination for these patients for prevention of PONV.

Methods: This study included 2 groups and 150 patients. At the time of wound closure, patients in group A received ondansetron 8 mg intravenous (IV) + dexamethasone 4 mg IV and group B received palonosetron 0.075 mg IV + dexamethasone 4 mg IV. Postoperatively for 48 hours, group A patients received ondansetron 4 mg 8 hourly IV, group B patients received normal saline 8 hourly IV in 2 cc syringe. The primary objective was the overall incidence of PONV. Independent t-test, Chi-square test, and Fisher's exact test were used and multivariate regression analysis was done.

Results: Vomiting was significantly higher in group A (37.3%) as compared with group B (21.3%) at 0-48 hours (P = 0.031). Significantly more patients in Group A had nausea as compared with group B at 90-120 minutes (30.66% vs 18.66%, P = 0.043) and 6-24 hours (32.0% vs 22.66%, P = 0.029). PCA opioid usage in microgram was significantly higher in group A at 0-24 hours (690.53 ± 332.57 vs 576.85 ± 250.79, P = 0.024) and 0-48 hours (1126.10 ± 512.18 vs 952.13 ± 353.85, P = 0.030).

Conclusion: Palonosetron with dexamethasone is more effective than ondasetron with dexamethasone for prevention of PONV in post-chemotherapy ovarian cancer surgeries receiving opioid-based patient controlled analgesia.

Keywords: Ondansetron; ovarian neoplasm; palonosetron; postoperative nausea and vomiting.

Conflict of interest statement

There are no conflicts of interest.

Figures

Figure 1
Figure 1
Consort diagram showing randomisation and the treatment allocation

References

    1. Bremner WG, Kumar CM. Delayed surgical emphysema, pneumomediastinum and bilateral pneumothoraces after postoperative vomiting. Br J Anaesth. 1993;71:296–7.
    1. Helmy SA. Prophylactic anti-emetic efficacy of ondansetron in laparoscopic cholecystectomy under total intravenous anaesthesia. A randomised, double-blind comparison with droperidol, metoclopramide and placebo. Anaesthesia. 1999;54:266–71.
    1. Choi SU. Is postoperative nausea and vomiting still the big “little” problem? Korean J Anesthesiol. 2016;69:1–2.
    1. Gan TJ, Diemunsch P, Habib AS, Kovac A, Kranke P, Meyer TA, et al. Consensus guidelines for the management of postoperative nausea and vomiting. Anesth Analg. 2014;118:85–113.
    1. 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.
    1. Chatterjee A, Sahu S, Paul M, Singh T, Singh S, Mishra P, et al. Comparison of efficacy of palonosetron-dexamethasone combination with palonosetron or dexamethasone alone for prophylaxis against post-operative nausea and vomiting in patients undergoing laparoscopic cholecystectomy. Indian J Anaesth. 2017;61:978–84.
    1. Tramèr MR. A rational approach to the control of postoperative nausea and vomiting: Evidence from systematic reviews. Part I. Efficacy and harm of antiemetic interventions, and methodological issues. Acta Anaesthesiol Scand. 2001;45:4–13.
    1. Tramèr MR, Reynolds DJ, Moore RA, McQuay HJ. Efficacy, dose-response, and safety of ondansetron in prevention of postoperative nausea and vomiting: A quantitative systematic review of randomized placebo-controlled trials. Anesthesiology. 1997;87:1277–89.
    1. Apfel CC, Heidrich FM, Jukar-Rao S, Jalota L, Hornuss C, Whelan RP, Zhang K, Cakmakkaya OS. Evidence-based analysis of risk factors for postoperative nausea and vomiting. Br J Anaesth. 2012;109:742–53.
    1. Kim YY, Moon SY, Song DU, Lee KH, Song JW, Kwon YE. Comparison of palonosetron with ondansetron in prevention of postoperative nausea and vomiting in patients receiving intravenous patient-controlled analgesia after gynecological laparoscopic surgery. Korean J Anesthesiol. 2013;64:122–6.
    1. Boogaerts JG, Vanacker E, Seidel L, Albert A, Bardiau FM. Assessment of postoperative nausea using a visual analogue scale. Acta Anaesthesiol Scand. 2000;44:470–4.
    1. Apfel CC, Läärä 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.
    1. Kovac AL. Prevention and treatment of postoperative nausea and vomiting. Drugs. 2000;59:213–43.
    1. Walder B, Schafer M, Henzi I, Tramèr MR. Efficacy and safety of patient-controlled opioid analgesia for acute postoperative pain. A quantitative systematic review. Acta Anaesthesiol Scand. 2001;45:795–804.
    1. Bhukal I, Srinivas N, Solanki SL, Yaddanapudi LN, Jain A. A randomized study to compare the efficacy of two intravenous fluid regimens of normal saline on the incidence of postoperative nausea and vomiting. Anesth Essays Res. 2012;6:21–4.
    1. 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.
    1. Singh PM, Borle A, Gouda D, Makkar JK, Arora MK, Trikha A, et al. Efficacy of palonosetron in postoperative nausea and vomiting (PONV) – A meta-analysis. J Clin Anesth. 2016;34:459–82.
    1. Li Y, Wei X, Zhang S, Zhou L, Zhang J. A meta-analysis of palonosetron for the prevention of postoperative nausea and vomiting in adults. J Perianesth Nurs. 2015;30:398–405.
    1. Candiotti KA, Ahmed SR, Cox D, Gan TJ. Palonosetron versus ondansetron as rescue medication for postoperative nausea and vomiting: A randomized, multicenter, open-label study. BMC Pharmacol Toxicol. 2014;15:45.
    1. Kovac AL, Eberhart L, Kotarski J, Clerici G, Apfel C. Palonosetron 04-07 Study Group. 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-hour period. Anesth Analg. 2008;107:439–44.
    1. Myles PS, Chan MT, Kasza J, Paech MJ, Leslie K, Peyton PJ, et al. Severe nausea and vomiting in the evaluation of nitrous oxide in the gas mixture for anesthesia II trial. Anesthesiology. 2016;124:1032–40.

Source: PubMed

3
Tilaa