DOI: http://dx.doi.org/10.18203/2319-2003.ijbcp20202552

Amisulpride: tackling postoperative nausea and vomiting not a nightmare any more

Ajay Kumar, Anuj Singh, D. B. S. Brashier, Awanish Karan, S. Sharma, Uday Pratap

Abstract


Vomiting and nausea remains concern in postoperative patients for anaesthesiologists and surgeons. Patients remain at risk for adverse medical consequences as wound dehiscence, dehydration, electrolyte derangement’s and gastric aspiration. This entity delays discharge and is one of the causes of unanticipated admission after ambulatory surgery. Presently dopamine (D2), serotonin (5-HT3), and histamine (H1) antagonists are widely used prophylactic agents, as is the corticosteroid dexamethasone, but the incidence of postoperative nausea and vomiting (PONV) is still appreciable. Safety concerns as QT interval prolongation has led to nearly phasing out of use of D2-antagonist Droperidol, a potent and most favoured formulation. With minimal studies and randomized studies to back up the efficacy of existing modalities viz 5HT-antagonist, promethazine, metoclopramide and dimenhydrinate for management of postoperative nausea and vomiting, need for evaluation, study and incorporation into formulary for management was always persisting. Amisulpride is an anti-psychotic agent, used routinely in >50 countries worldwide is a potent but atypical D2-antagonist with minimal adverse profile mainly QT interval prolongation, extrapyramidal signs and symptoms, which had plagued out other members of same class. In addition to D2 antagonism this drug exhibits potent antagonist action against D3 receptors, implicated in the emetic response. In pre clinical studies and multiple randomized controlled multicenter studies the effectiveness and safety of low dose intra venous Amisulpride was established and approved as Barhemsys @Acacia Pharma by US Food and drug administration in February 2020. This drug will soon add to protocol-based management of PONV.


Keywords


Postoperative nausea and vomiting, D2 antagonist, Amisulpride, QT interval

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References


Diemunsch P, Joshi GP, Brichant JF. Neurokinin-1 receptor antagonists in the prevention of postoperative nausea and vomiting. Br J Anaesth. 2009;103:7-13.

Apfel CC, Kranke P, Eberhart LH, Roos A, Roewer N. Comparison of predictive models for postoperative nausea and vomiting. Br J Anaesth 2002;88:234-40.

Macario A, Weinger M, Carney S, Kim A. Which clinical anesthesia outcomes are important to avoid? The perspective of patients. Anesth Analg. 1999;89:652-8.

Kranke P, Eberhart LH, Toker H, Roewer N, Wulf H, Kiefer P. A pro-spective evaluation of the POVOC score for the prediction of post-operative vomiting in children. Anesth Analg. 2007;105:1592-7.

Hill RP, Lubarsky DA, Phillips-Bute B, Fortney JT, Creed MR, Glass PS, et al. Cost effectiveness of prophylactic antiemetic therapy with ondanse-tron, droperidol, or placebo. Anesthesiology. 2000;92:958-67.

Fortier J, Chung F, Su J: Unanticipated admission after ambulatory surgery a prospective study. Can J Anaesth 1998; 45:612-9.

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

Koivuranta M, Läärä E, Snåre L, Alahuhta S. A survey of postoperative nausea and vomiting. Anaesthesia 1997;52:443-9.

Chung F, Mezei G: Factors contributing to a prolonged stay after ambulatory surgery. AnesthAnalg 1999; 89:1352-9.

Gan TJ, Diemunsch P, Habib AS, Kovac A, Kranke P, Meyer TA, et al. Society for Ambulatory Anesthesia:Consensus guidelines for the management of post-operative nausea and vomiting. Anesth Analg. 2014;118:85-113.

Kooij FO, Klok T, Hollmann MW, Kal JE. Automated reminders increase adherence to guidelines for administration of prophylaxis for postoperative nausea and vomiting. Eur J Anaesthesiol. 2010;27:187-91.

White PF, O’Hara JF, Roberson CR, Wender RH, Candiotti KA. POST-OP Study Group: The impact of current antiemetic practices on patient outcomes:a prospective study on high-risk patients. Anesth Analg. 2008;107:452-8.

Habib AS, Gan TJ. The use of droperidol before and after the Food and Drug Administration black box warning:A survey of the members of the Society of Ambulatory Anesthesia. J Clin Anesth. 2008;20:35-9.

Habib AS, Gan TJ. The effectiveness of rescue anti-emetics after failure of prophylaxis with ondansetron or droperidol: A preliminary report. J Clin Anesth. 2005;17:62-5.

Habib AS, Chen YT, Taguchi A, Hu XH, Gan TJ. Postoperative nausea and vomiting following inpatient surgeries in a teaching hospital: A retrospective data-base analysis. Curr Med Res Opin. 2006;22:1093-9.

Habib AS, Reuveni J, Taguchi A, White WD, Gan TJ. A comparison of ondansetron with promethazine for treating postoperative nausea and vomiting in patients who received prophylaxis with ondansetron:A retrospective database analysis. Anesth Analg. 2007;104:548-51.

Meyer TA, Roberson CR, Rajab MH, Davis J, McLeskey CH. Dolasetron versus ondansetron for the treatment of postoperative nausea and vomiting. Anesth Analg. 2005;100:373-7.

Kovac AL, O’Connor TA, Pearman MH, Kekoler LJ, Edmondson D, Baughman VL. Efficacy of repeat intravenous dosing of ondansetron in controlling postoperative nausea and vomiting: A randomized, double-blind, placebo-controlled multi-center trial. J Clin Anesth. 1999;11:453-9.

Candiotti KA, Nhuch F, Kamat A, Deepika K, Arheart KL, Birnbach DJ, et al. Granisetron versus ondansetron treatment for breakthrough postoperative nausea and vomiting after prophylactic ondansetron failure: A pilot study. Anesth Analg, 2007;104:1370-3.

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.

Macario A, Claybon L, Pergolizzi JV. Anesthesiologists’ practice patterns for treatment of postoperative nausea and vomiting in the ambulatory Post Anesthesia Care Unit. BMC Anesthesiol. 2006;6:6

Coulouvrat C, Dondey-Nouvel L. Safety of Amisulpride (Solian): A review of 11 clinical studies. Int Clin Psychopharmacol. 1999;14:209-18.

Kranke P, Eberhart L, Motsch J, Chassard D, Wallenborn J, Diemunsch P, et al. I.V. APD421 (Amisulpride) prevents postoperative nausea and vomiting:A randomized, double-blind, placebo-controlled, multicentre trial. Br J Anaesth. 2013;111:938-45.

Gan TJ, Kranke P, Minkowitz HS, Bergese SD, Motsch J, Eberhart L, et al. Intravenous Amisulpride for the prevention of postoperative nausea and vomiting:Two concurrent, randomized, double-blind, placebo-controlled trials. Anesthesiology. 2017;126:268-75.

National Center for Biotechnology Information. PubChem Database. Amisulpride, CID=2159. Available at: https://pubchem.ncbi.nlm.nih.gov/ compound/Amisulpride. Accessed on May 17 2020.

Habib AS, Kranke P, Bergese SD, Chung F, Ayad S, Siddiqui N, et al. Amisulpride for the Rescue Treatment of Postoperative Nausea or Vomiting in Patients Failing Prophylaxis:A Randomized, Placebo-controlled Phase III Trial. Anesthesiology. 2019;130:203-12.

Kranke P, Bergese SD, Minkowitz HS, Melson TI, Leiman DG, Candiotti KA, et al. Amisulpride Prevents Postoperative Nausea and Vomiting in Patients at High Risk: A Randomized, Double-blind, Placebo-controlled Trial. Anesthesiology. 2018;128(6):1099-106.

Rosenzweig P, Canal M, Patat A, Bergougnan L, Zieleniuk I, Bianchetti G. A review of the pharmacokinetics, tolerability and pharma-codynamics of Amisulpride in healthy volunteers. Hum Psychopharmacol. 2002;17(1):1-13.

Abbas, AI, Hedlund, PB, Huang X, Tran TB, Meltzer HY, Roth BL. Amisulpride is a potent 5-HT7 antagonist: relevance for antidepressant actions in vivo. Psychopharmacology. 2009;205:119-28.

Zhang L, Zhang C, Tang W, He L, Liu Y, Tian DD, et al. Efficacy of Amisulpride on postoperative nausea and vomiting:a systematic review and meta-analysis. Eur J Clin Pharmacol. 2020.

US Phase III Study of APD421 in PONV. Available at: https://www.clinicaltrials.gov/ct2/show/NCT0199 1860?term=NCT01991860&cond=%22Postoperative+Nausea+and+Vomiting%22&draw=2&rank=1. Accessed on 3 May 2020.

Clinicaltrials. Available at: https://www.clinicaltrials. gov/ct2/results?cond=&term=NCT02337062&cntry=&state=&city=&dist=. Accessed on 3 May 2020.

Clinicaltrials. Available at: https://www.clinicaltrials. gov/ct2/results?cond=&term=NCT02449291&cntry=&state=&city=&dist=. Accessed on 3 May 2020.

Clinicaltrials. Available at: https://www.clinicaltrials. gov/ct2/results?cond=&term=NCT02646566&cntry=&state=&city=&dist=. Accessed on 3 May 2020.

Habib AS, Kranke P, Bergese SD, Chung F, Ayad S, Siddiqui N, et al. Amisulpride for the Rescue Treatment of Postoperative Nausea or Vomiting in Patients Failing Prophylaxis:A Randomized, Placebo-controlled Phase III Trial. Anesthesiology. 2019;130(2):203-12.