Effects of palonosetron and dexamethasone on postoperative nausea and vomiting in adult patients undergoing laparoscopic abdominal surgery: a randomized, double-blind, clinical trial at a tertiary care hospital
DOI:
https://doi.org/10.18203/2349-3933.ijam20163747Keywords:
Abdominal surgery, Dexamethasone, Laparoscopic, Palonosetron, PONV, Randomized controlled trialAbstract
Background: Post-operative nausea and vomiting (PONV) is one of the common problems after laparoscopic abdominal surgery. It hampers the postoperative recovery in spite of the availability of many antiemetic drugs and regimens for its prevention. We evaluated the effectiveness of intravenous (IV) palonosetron in counteracting PONV during the first 48hrs following laparoscopic abdominal surgery, using dexamethasone as the comparator drug.
Methods: In this study a single pre-induction IV doses of palonosetron (75mcg) or dexamethasone (8mg) were administered to adult patients of either sex undergoing elective laparoscopic abdominal surgery. There were 40 subjects per group. The pre-anesthetic regimen, anesthesia procedure and laparoscopic technique were uniform. The primary effectiveness measure was total number of PONV episodes in the 48 hours period following end of surgery. The frequencies of individual nausea, retching and vomiting episodes, visual analog scale (VAS) score for nausea at 2, 6, 12, 24 and 48 hours, use of rescue antiemetic (metoclopramide), number of complete responders (no PONV or use of rescue in 48 hours) and adverse events were secondary measures. SPSS software version 16 was employed to using student’s t-test, chi-square test or fisher’s exact tests. Value of P < 0.05 was considered significant.
Results: The incidence of nausea and vomiting was maximal during the first six hours postoperatively. The complete control of postoperative nausea and vomiting for first 24 hours was achieved in 80% patients of palonosetron group and 60% patients of dexamethasone group. During 24-48 hours the incidence of PONV was 17.5% and 22.5% respectively in palonosetron group and dexamethasone group. The use of rescue medication is about 50% less in the use of palonosetron as antiemetic than dexamethasone. Safety profile was similar in both the groups.
Conclusions: Palonosetron is comparatively highly effective to prevent the PONV after anaesthesia in elective laparoscopic abdominal surgery when administered as single pre-induction dose due to its prolonged duration of action than dexamethasone.
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References
Jindani A, Aber VR, Edwards EA, Mitchison DA. The early bactericidal activity of drugs in patients with pulmonary tuberculosis. Am Rev Respir Dis. 1980;121(6):939-49.
Turkistani A, Abdullah K, Manaa E, Delvi B, Khairy G, Abdulghani B, et al, Effect of fluid preloading on postoperative nausea and vomiting following laparoscopic cholecystectomy. Saudi J Anaesth. 2009;3(2):48-52.
Grover VK, Mathew PJ, Hegde H. Efficacy of orally disintegrating ondansetron in preventing postoperative nausea and vomiting after laparoscopic cholecystectomy: a randomised, double-blind placebo controlled study. Anaesthesia, 2009;64(6):595-600.
Feo CV, Sortini D, Ragazzi R, De Palma M, Liboni A. Randomized clinical trial of the effect of preoperative dexamethasone on nausea and vomiting after laparoscopic cholecystectomy. Br J Surg. 2006;93(3):295-9.
Nesek-Adam V, Grizelj-Stojcić E, Rasić Z, Cala Z, Mrsić V, Smiljanić A. Comparison of dexamethasone, metoclopramide, and their combination in the prevention of postoperative nausea and vomiting after laparoscopic cholecystectomy. Surg Endosc. 2007;21(4):607-12.
Leksowski K, Peryga P, Szyca R. Ondansetron, metoclopramid, dexamethason, and their combinations compared for the prevention of postoperative nausea and vomiting in patients undergoing laparoscopic cholecystectomy: a prospective randomized study. Surg Endosc. 2006;20(6):878-82.
Bunce KT, Tyers MB. The role of 5-HT in postoperative nausea and vomiting. Br J Anaesth. 1992;69(7 Suppl 1):60S-2S.
Watcha MF, White PF. Postoperative nausea and vomiting. Its etiology, treatment, and prevention. Anesthesiology. 1992;77(1):162-84.
Wallenborn J, Eberhart LH, Kranke P. Postoperative nausea and vomiting--what's new in anti-emetic pharmacotherapy? Anasthesiol Intensivmed Notfallmed Schmerzther. 2009;44(4):296-304;quiz 305.
Kloth DD. New pharmacologic findings for the treatment of PONV and PDNV. Am J Health Syst Pharm. 2009;66(1 Suppl 1):S11-8.
Navari RM. Palonosetron: a second-generation 5-hydroxytryptamine receptor antagonist. Future Oncol. 2006;2(5):591-602.
Rojas C, Thomas AG, Alt J, Stathis M, Zhang J, Rubenstein EB, et al. Palonosetron triggers 5-HT(3) receptor internalization and causes prolonged inhibition of receptor function. Eur J Pharmacol. 2010;626(2-3):193-9.
Gralla R, Lichinitser M, Van Der Vegt S, Sleeboom H, Mezger J, Peschel C, Tonini G, 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(10):1570-7.
Moon YE, Joo J, Kim JE, Lee Y. Anti-emetic effect of ondansetron and palonosetron in thyroidectomy: a prospective, randomized, double-blind study. Br J Anaesth. 2012;108(3):417-22.
Holte K, Kehlet H. Perioperative single-dose glucocorticoid administration: pathophysiologic effects and clinical implications. J Am Coll Surg. 2002;195(5):694-712.
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(2):469-78.
Muchatuta NA, Paech MJ. Management of postoperative nausea and vomiting: focus on palonosetron. Ther Clin Risk Manag. 2009;5:21-34.
Naguib M, el Bakry AK, Khoshim MH, Channa AB, el Gammal M, el Gammal K, al. Prophylactic antiemetic therapy with ondansetron, tropisetron, granisetron and metoclopramide in patients undergoing laparoscopic cholecystectomy: a randomized, double-blind comparison with placebo. Can J Anaesth. 1996;43(3):226-31.
Wang JJ, Ho ST, Liu YH, Lee SC, Liu YC, Liao YC, Ho CM. Dexamethasone reduces nausea and vomiting after laparoscopic cholecystectomy. Br J Anaesth. 1999;83(5):772-5.
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(2):439-44.
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(2):445-51.
Bianchin A, De Luca A, Caminiti A. Caminiti, Postoperative vomiting reduction after laparoscopic cholecystectomy with single dose of dexamethasone. Minerva Anestesiol. 2007;73(6):343-6.
Fujii Y, Itakura M. Reduction of postoperative nausea, vomiting, and analgesic requirement with dexamethasone for patients undergoing laparoscopic cholecystectomy. Surg Endosc. 2010;24(3):692-6.
Henzi I, Walder B, Tramèr MR. Dexamethasone for the prevention of postoperative nausea and vomiting: a quantitative systematic review. Anesth Analg. 2000;90(1):186-94.
Hargreaves KM, Costello A. Glucocorticoids suppress levels of immunoreactive bradykinin in inflamed tissue as evaluated by microdialysis probes. Clin Pharmacol Ther. 1990;48(2):168-78.
Dabbous AS, Jabbour-Khoury SI, Nasr VG, Moussa AA, Zbeidy RA, Khouzam NE, et al., Dexamethasone with either granisetron or ondansetron for postoperative nausea and vomiting in laparoscopic surgery. Middle East J Anaesthesiol. 2010;20(4):565-70.
Jo YY, Lee JW, Shim JK, Lee WK, Choi YS. Ramosetron, dexamethasone, and their combination for the prevention of postoperative nausea and vomiting in women undergoing laparoscopic cholecystectomy. Surg Endosc. 2012;26(8):2306-11.
Piper SN, Triem JG, Röhm KD, Kranke P, Maleck WH, Boldt J. Prevention of post-operative nausea and vomiting. Randomised comparison of dolasetron versus dolasetron plus dexamethasone. Anaesthesist. 2003;52(2):120-6.
Karanicolas PJ, Smith SE, Kanbur B, Davies E, Guyatt GH. The impact of prophylactic dexamethasone on nausea and vomiting after laparoscopic cholecystectomy: a systematic review and meta-analysis. Ann Surg. 2008;248(5):751-62.
Murphy GS, Szokol JW, Greenberg SB, Avram MJ, Vender JS, Nisman M, et al. Preoperative dexamethasone enhances quality of recovery after laparoscopic cholecystectomy: effect on in-hospital and postdischarge recovery outcomes. Anesthesiology. 2011;114(4):882-90.
Aspinall RL, Goodman NW. Denial of effective treatment and poor quality of clinical information in placebo controlled trials of ondansetron for postoperative nausea and vomiting: a review of published trials. BMJ. 1995;311(7009):844-6.
