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British Journal of Anaesthesia, Vol 76, Issue 1 54-60, Copyright © 1996 by The Board of Management and Trustees of the British Journal of Anaesthesia

CLINICAL INVESTIGATIONS

Single dose i.v. tropisetron in the prevention of postoperative nausea and vomiting after gynaecological surgery

V. Capouet, C. De Pauw, B. Vernet, D. Ivens, V. Derijcke, L. Versichelen, H. van Aken, B. Ickx, L. Ritter and F. Hulstaert
Centre Hospitalier Universitaire Vesale, Montigny-le-Tilleul; Heilig Hartkliniek, Eeklo; Cliniques Universitaires Saint-Luc, Brussels; Akademisch Ziekenhuis VUB, Brussels; Algemeen Ziekenhuis Heilige Familie, Ghent; Universitair Ziekenhusi Gent, Ghent; Universitair Ziekenhusi Gasthuisberg, Leuven; Hopital Eraseme, Brussels; International Institute for Drug Development, Brussels; Sandoz Pharma, Brussels, Belgium

In a prospective, randomized, multicentre, double-blind, placebo- controlled study, we have compared the efficacy of a single i.v. dose of tropisetron 0.5 mg, 2 mg and 5 mg in the prevention of postoperative nausea and vomiting (PONV). We studied 385 ASA class I and II female patients undergoing abdominal or vaginal gynaecological surgery, including laparoscopy. Tropisetron or placebo were administered before a standardized general anaesthetic. The frequency of vomiting in the 24- h period after entry into the recovery room was reduced from 44% after placebo to 31%, 26% and 30% after tropisetron 0.5 mg, 2 mg and 5 mg, respectively (P = 0.06, P = 0.009 and P = 0.043; unadjusted). Compared with placebo, nausea was reduced from 55% to 46%, 34% and 46% (P = 0.25, P = 0.003, P = 0.22), and need for rescue treatment from 39% to 29%, 23% and 35% (P = 0.13, P = 0.017 and P = 0.59) for the same groups. Tropisetron 2 mg appeared to be the optimal dose for prophylaxis against PONV with a side-effect profile similar to that of placebo.
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