Abstract
Purpose
To compare the efficacy, safety, and tolerability of dolasetron mesilate with placebo for the treatment of postoperative nausea and vomiting (PONV).
Methods
In a randomized, multicentre, double-blind, placebo-controlled study 337 adult patients undergoing surgery with general anaesthesia received one of four single, doses of dolasetron mesilateiv (12.5, 25, 50. or 100 mg) or placebo. Study medication was administered postoperatively when the patient reported nausea lasting 10 mm or when one emetic episode occurred within two hours of the patient’s arrival in the recovery room. Efficacy was assessed by the investigators over the 24-hr study penod by recording the number and timing of emetic episodes, the severity of nausea, the timing of administration of escape antiemetic medications. and patients’ and investigators’ satisfaction with antiemetic therapy.
Results
The study sample was predominately women, and the surgical procedures were primarily gynaeco logical. All dolasetron mesilate doses produced higher complete response rates than placebo (P< 0.05). Only approximately one-third of dolasetron patients required escape antiemetic medication compared with more than 50% of patients in the placebo group. Both patient and physician satisfaction with dolasetron treatment was high. The most common adverse event was mild or moderate headache for both placebo-treated patients and dolasetron-treated patients. Clinical laboratory results were unremarkable.
Conclusion
Single doses of dolasetron mesilateiv, given after the first episode of PONV were both effective and safe in this adult patient population.
Résumé
Objectif
Comparer l’efficacité, la sécurité et l’acceptabilité du mésilate de dolasetron avec celles d’un placebo pour le traitement des nausées et vomissements postopératoires (NVPO).
Méthodes
Au cours d’une étude multicentrique, en double aveugle, contrôlée par placebo. 337 adultes soumis à une chirurgie sous anesthésie générale ont reçu du mésilate de dolasetron à une de quatre posologies iv (12,5. 25. 50, ou 100 mg) ou un placebo. Le médicament était administré en postopératoire lorsque le patient se plaignait d’une nausée de durée 10 min ou quand au moins en épisode émétique survenait au cours des deux heures suivant l’arrivée du patient en salle de réveil. Sur une période d’étude de 24 h, l’efficacité était évaluée par les investigateurs par l’enregistrement du nombre et de la chronologie des épisodes, la gravité de la nausée, le temps de l’administration de la médication antiémétique de rattrapage, et la satisfaction du patient ou de l’investigateur envers le traitement.
Résultats
L’échantillon de la population étudiée comprenait surtout des femmes et les interventions étaient surtout gynécologiques. Toutes les doses de mésilate de dolasetron procuraient une réponse complète plus fréquente que le placebo (P < 0,05). Seulement un tiers environ des patients sous dolasetron ont eu besoin d’un médicament antiémétique de rattrapage comparativement à plus de 50% du groupe placebo. La satisfaction du chirurgien et de l’anesthésiste à l’égard de la prévention réalisée par le dolasetron était élevée. Une céphalée légère ou modérée constituait la réaction défavorable la plus fréquente tant chez les patients sous placebo que sous dolasetron. Les résultats des examens de laboratoire étaient non significatifs.
Conclusion
Chez une population adulte, les doses uniques de mésilate de dolasetroniv administrées après un premier épisode de NVPO sont à la fois efficaces et bien tolérées.
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This study was supported by a grant from Hoechst Marion Roussel, Inc.
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Diemunsch, P., Leeser, J., Feiss, P. et al. Intravenous dolasetron mesilate ameliorates postoperative nausea and vomiting. Can J Anaesth 44, 173–181 (1997). https://doi.org/10.1007/BF03013007
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DOI: https://doi.org/10.1007/BF03013007