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Anasthesiol Intensivmed Notfallmed Schmerzther · Jul 2001
Randomized Controlled Trial Comparative Study Clinical Trial[Prophylaxis of nausea and vomiting after thyroid surgery: comparison of oral and intravenous dolasetron with intravenous droperidol and placebo].
- K Danner, H G Becker, B Best, and C Madler.
- Institut für Anästhesiologie und Notfallmedizin, Westpfalz Klinikum GmbH Kaiserslautern.
- Anasthesiol Intensivmed Notfallmed Schmerzther. 2001 Jul 1;36(7):425-30.
ObjectivePostoperative nausea and vomiting (PONV) are among the most common complications in operative medicine. Especially thyroid surgery is frequently associated with PONV. It was the aim of this study to determine the efficacy of oral and intravenous dolasetron in comparison to intravenous droperidol (DHB) and placebo in the prevention of PONV.Methods93 female and 43 male patients undergoing thyroid surgery were stratified according to gender and then randomised to receive double-blind one of four antiemetic regimes: 50 mg dolasetron given orally 45 minutes prior to induction of anaesthesia (group I), 12.5 mg dolasetron given intravenously during induction of anaesthesia (group II), 1.25 mg DHB given intravenously during induction of anaesthesia (group III) or placebo (group IV). General anaesthesia and preoperative management of the patients were standardised: premedication with chloracepate-dipotassium, induction with thiopentone, sufentanil and rocuronium, maintenance with N2O/O2, sevoflurane and repetitive doses of sufentanil and rocuronium, postoperative analgesia with metamizol and piritramide, antiemetic rescue-treatment with dimenhydrinate, metoclopramide and triflupromazine. Number of emetic episodes, the need for additional antiemetics and adverse events were recorded for 24 hours. Efficacy was measured by "complete-response" (CR = 0 emetic episodes or 1 emetic episode after 4 hours and no rescue-treatment) and "total-response" (TR = complete response plus no nausea, i.e., < 5 mm VAS rating of patients maximum nausea).ResultsMen: Only Dolasetron given intravenously reduced nausea and vomiting significantly, Dolasetron given orally reduced nausea, but not vomiting, DHB had no significant effects: CR 72.7% (group I), 100% (group II), 80% (group III), 63.6% (group IV); TR 72.7% (group I), 81.8% (group II), 50% (group III), 36.4% (group IV). Women: In all three treatment groups significantly less patients suffered from PONV compared to the placebo group (p < 0.05). There were no differences between the treatment groups: CR 58.3% (group I), 45.8% (group II), 52.2% (group III), 18.1% (group IV); TR 37.5% (group I), 33.3% (group II), 39.1% (group III), 13.6% (group IV). There were no adverse events in any group.ConclusionsOur results confirm the expected high incidence of PONV after thyroid surgery, especially in female patients. Single doses of oral and intravenous dolasetron and intravenous droperidol reduced PONV effectively in female patients undergoing thyroid surgery. Dolasetron seems to be the more effective substance in male patients. Both substances can be administered safely and are well tolerated.
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