A prospective, randomized, double-blind trial to compare body weight-adjusted and fixed doses of palonosetron for preventing postoperative nausea and vomiting in obese female patients


Autoři: Nathalia Gouveia de Araujo Ferreira aff001;  Ismar Lima Cavalcanti aff003;  Alexandra Rezende Assad aff003;  Louis Barrucand aff004;  Estêvão Luiz Carvalho Braga aff004;  Nubia Verçosa aff005
Působiště autorů: Department of Anesthesiology, National Cancer Institute (HCIII), Rio de Janeiro, Rio de Janeiro, Brazil aff001;  Postgraduate Program Surgical Sciences, Federal University of Rio de Janeiro, Rio de Janeiro, Rio de Janeiro, Brazil aff002;  Department of General and Specialized Surgery/Anesthesiology, Fluminense Federal University, Niterói, Rio de Janeiro, Brazil aff003;  Faculty of Medicine, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil aff004;  Department of Surgery/Anesthesiology, Postgraduate Program Surgical Sciences, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil aff005
Vyšlo v časopise: PLoS ONE 15(1)
Kategorie: Research Article
doi: 10.1371/journal.pone.0227490

Souhrn

Background

Postoperative nausea and vomiting (PONV) is a common postsurgical complication. Palonosetron is effective for PONV prevention at the usual dose of 75 μg, but the ideal dose for obese patients has not yet been investigated. The aim of this study was to compare body weight-adjusted and fixed doses of palonosetron for preventing PONV in obese female patients.

Materials and methods

We performed a prospective, randomized, double-blind trial involving 80 female patients, aged 18–80 years with an American Society of Anesthesiologists physical status of 2 and 3 and a body mass index (BMI) ≥ 30 kg m-2 who were scheduled to undergo elective breast surgery. Patients received an intravenous body weight-adjusted dose of palonosetron (1 μg kg -1, GI = 40 patients) or a fixed dose of palonosetron (75 μg, GII = 40 patients). All patients received dexamethasone (4 mg). The incidence of PONV, complete response rate (CR), severity of nausea and need for rescue antiemetics and analgesics were assessed at: 0–1 h, 1–6 h, 6–24 h and 24–48 h postoperatively.

Results

The mean (± SD) BMI was 35.0 (±5.2) kg m-2 for GI and 35.7 (±3.6) kg m-2 for GII. There was no significant difference between groups in PONV incidence, CR, severity of nausea, and need for rescue antiemetics or analgesics. The incidence of PONV for GI and GII was 15% and 27.5%, respectively, during the first 48 h (P = 0.17).

Conclusions

A body weight-adjusted dose of palonosetron was as effective as 75 μg for preventing PONV for 48 h in obese female patients who underwent breast surgery. Hence, the fixed dose may be preferable to the body weight-adjusted dose.

Klíčová slova:

Analgesics – Body mass index – Nausea – Obesity – Opioids – Prophylaxis – Surgical and invasive medical procedures – Vomiting


Zdroje

1. Gan TJ, Diemunsch P, Habib AS, Kovak A, Kranke P, Meyer TA, et al. Consensus guidelines for the management of postoperative nausea and vomiting. Anesth Analg. 2014; 118: 85–113. doi: 10.1213/ANE.0000000000000002 24356162

2. 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. doi: 10.1177/147323001103900207 21672343

3. Moon HY, Baek CW, Choi GJ, Shin HY, Kang H, Jung YH, et al. Palonosetron and aprepitant for the prevention of postoperative nausea and vomiting in patients indicated for laparoscopic gynaecologic surgery: a double-blind randomized trial. BMC Anesthesiol. 2014; 14: 68–75. doi: 10.1186/1471-2253-14-68 25165427

4. Silva AC, O’Ryan F, Poor DB. Postoperative nausea and vomiting (PONV) after orthognathic surgery: a retrospective study and literature review. J Oral Maxillofac Surg. 2006; 64: 1385–1397. doi: 10.1016/j.joms.2006.05.024 16916674

5. Kim SH, Hong JY, Kim WO, Kil HK, Karm MH, Hwang JH. Palonosetron has superior prophylactic antiemetic efficacy compared with ondansetron or ramosetron in high-risk patients undergoing laparoscopic surgery: a prospective, randomized, double-blinded study. Korean J Anesthesiol. 2013; 64: 517–523. doi: 10.4097/kjae.2013.64.6.517 23814652

6. Horn CC, Wallisch WJ, Homanics GE, Williams JP. Pathophysiological and neurochemical mechanisms of postoperative nausea and vomiting. Eur J Pharmacol. 2014; 722: 55–66. doi: 10.1016/j.ejphar.2013.10.037 24495419

7. Candiotti KA, Kovac AL, Melson TI, Clerici G, Gan TJ. 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: 445–451. doi: 10.1213/ane.0b013e31817b5ebb 18633022

8. 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: 520–531. doi: 10.1177/0091270004264641 15102873

9. Rojas C, Stathis M, Thomas AG, Massuda EB, Alt J, Zhang J, et al. Palonosetron exhibits unique molecular interactions with the 5-HT3 receptor. Anesth Analg. 2008; 107: 469–478 doi: 10.1213/ane.0b013e318172fa74 18633025

10. Eisenberg P, MacKintosh FR, Ritch P, Cornett PA, Macciocchi A. Efficacy, safety and pharmacokinetics of palonosetron in patients receiving highly emetogenic cisplatin-based chemotherapy: a dose-ranging clinical study. Ann Oncol. 2004; 15: 330–337. doi: 10.1093/annonc/mdh047 14760130

11. Carvalho ELB, Figueiredo NV, Barrucand L, Cavalcanti IL. Use of palonosetron and ondansetron in the prophylaxis of postoperative nausea and vomiting in women 60 years of age or older undergoing laparoscopic cholecystectomy: A randomised double-blind study. Eur J Anaesthesiol. 2019; 36(3): 241–242. doi: 10.1097/EJA.0000000000000932 30694891

12. Bicer C, Aksu R, Ulgey A, Madenoglu H, Dogan H, Yildiz K, et al. Different doses of palonosetron for the prevention of postoperative nausea and vomiting in children undergoing strabismus surgery. Drugs R D. 2011; 11: 29–36. doi: 10.2165/11586940-000000000-00000 21284406

13. Jain D, Jain K, Bala I, Gandhi K. Evaluation of weight-adjusted doses of palonosetron for prevention of postoperative nausea and vomiting in day care laparoscopic gynaecological surgery. A dose ranging randomized controlled trial. Eur J Anaesthesiol. 2016; 33: 104–109. doi: 10.1097/EJA.0000000000000391 26673802

14. 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. doi: 10.1097/00000542-199909000-00022 10485781

15. Swaro S, Karan D, Banerjee A. Comparison of palonosetron, dexamethasone, and palonosetron plus dexamethasone as prophylactic antiemetic and antipruritic drug in patients receiving intrathecal morphine for lower segment cesarean section. Anesth Essays Res. 2018; 12: 322–327. doi: 10.4103/aer.AER_183_17 29962591

16. Bala I, Bharti N, Murugesan S, Gupta R. Comparison of palonosetron with palonosetron-dexamethasone combination for prevention of postoperative nausea and vomiting in patients undergoing laparoscopic cholecystectomy. Minerva Anestesiol. 2014; 80: 779–784. 24280811

17. Chatterjee A, Sahu S, Paul M, Singh T, Singh S, Mishra P. 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: 978–984. doi: 10.4103/ija.IJA_317_17 29307903

18. Ryu JH, Jeon YT, Min B, Hwang JY, Sohn HM. Effects of palonosetron for prophylaxis of postoperative nausea and vomiting in high-risk patients undergoing total knee arthroplasty: A prospective, randomized, double-blind, placebo-controlled study. PLoS ONE. 2018; 13: e0196388. doi: 10.1371/journal.pone.0196388 29758039

19. Blitz JD, Haile M, Kline R, Franco L, Didehvar S, Pachter HL, et al. A randomized double-blind study to evaluate efficacy of palonosetron with dexamethasone versus palonosetron alone for prevention of postoperative and post discharge nausea and vomiting in subjects undergoing laparoscopic surgeries with high emetogenic risk. Am J Ther. 2012; 19: 324–329. doi: 10.1097/MJT.0b013e318209dff1 21519222

20. Candiotti KA, Birnbach DJ, Lubarsky DA, Nhuch F, Kamat A, Koch WH, et al. The impact of pharmacogenomics on postoperative nausea and vomiting: does CYP2D6 allele copy number and polymorphisms affect the success or failure of ondansetron prophylaxis? Anesthesiology. 2005; 102: 543–549. doi: 10.1097/00000542-200503000-00011 15731591

21. Bang YS, Kim YU, Oh D, Shin EY, Park SK. 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. J Anesth. 2016; 30: 935–940. doi: 10.1007/s00540-016-2249-3 27650295

22. Bhattacharjee DP, Dawn S, Nayak S, Roy PR, Acharya A, Dey R. A comparative study between palonosetron and granisetron to prevent postoperative nausea and vomiting after laparoscopic cholecystectomy. J Anaesthesiol Clin Pharmacol. 2010; 26: 480–483. 21547174

23. Park SK, Cho EJ. A randomized controlled trial of two different interventions for the prevention of postoperative nausea and vomiting: total intravenous anaesthesia using propofol and remifentanil versus prophylactic palonosetron with inhalational anaesthesia using sevoflurane–nitrous oxide. J Internat Med Res. 2011; 39: 1808–1815.

24. Kumar A, Solanki SL, Gangakhedkar GR, Shylasree TS, Sharma KS. 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. Indian J Anaesth. 2018; 62: 773–779. doi: 10.4103/ija.IJA_437_18 30443060

25. Pierre S, Whelan R. Nausea and vomiting after surgery. Continuing Education in Anaesthesia Critical Care & Pain. 2013; 13: 28–32.

26. Cho E, Kim DH, Shin S, Kim SH, Oh YJ, Choi YS. Efficacy of palonosetron-dexamethasone combination versus palonosetron alone for preventing nausea and vomiting related to opioid-based analgesia: a prospective, randomized, double-blind trial. Int J Med Sci. 2018; 15: 961–968. doi: 10.7150/ijms.24230 30013436

27. 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-hour period. Anesth Analg 2008; 107:439–44. doi: 10.1213/ane.0b013e31817abcd3 18633021


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