Abstract
Purpose
The incidence of postoperative nausea and vomiting (PONV) varies from 50% to 75% after gynaecological surgery under general anaesthesia. This study evaluates the dose-response relationships, safety, and efficacy of the new 5-HT3 antagonist, dolasetron mesylate, in the prevention of PONV in women undergoing total abdominal hysterectomy (TAH).
Methods
Three hundred and seventy four women scheduled for TAH under general anaesthesia were studied at 13 Canadian centres. Patients received in a randomized, double-Wind manner 25, 50, 100, or 200 mg dolasetron or placebo po one to two hours before induction of anaesthesia. The anesthetic protocol was standardized. Efficacy was evaluated for 24 hr after surgery by companng the number of emetic episodes, administration of rescue medication, seventy of nausea, and patient satisfaction.
Results
Analysis of complete response (no emetic episodes and no rescue for 24 hr) revealed a linear doseresponse relationship across dolasetron groups (P < 0.002). Dolasetron 100 mg (P < 0.003) and 200 mg (P < 0.01) were superior to placebo. The percentage of patents with no emetic episodes increased from 29.3% (placebo) to 54.1 % (100 mg). Subgroup analysis revealed ASA status (I > II), previous history of PONV, previous history of motion sickness, and total morphine dose (> 55 mg associated with less PONV than < 55 mg) influenced the incidence of emetic symptoms, but did not alter the results of the primary analysis.
Conclusion
Prophylactic dolasetron (100 mg and 200 mg) reduces the incidence of PONV in patients having total abdominal hysterectomy.
Résumé
Objectif
Après une intervention gynécologique sous anesthésie générale, l’incidence des nausées et des vomissements postopératoires (NVPO) vane de 50% à 75%. Cette étude évalue la relation dose-effet, la sécurité et l’efficacité d’un nouvel antagoniste 5-HT3, le mésytate de dolasetron, lorsque administré pour prévenir les NVPO chez des femines soumises à une hystérectomie abdominale totale (HAT).
Méthodes
Trois cent soixante-quatorze femines programinées pour une HAT sous anesthésie générale ont participé à l’étude dans 13 centres canadiens. Les patentes ont reçu en double aveugle et aléatoirement 25, 50, 100 et 200 mg de dolasetron ou un placebopo une ou deux heures avant l’induction de l’anesthésie selon un protocole standard. L’efficacité a été évaluée pendant 24 h après la chirurgie en comparant le nombre d’épisodes émétiques, l’administration d’un médicament de sauvetage, la gravité des nausées et le degré de satisfaction.
Résultats
L’analyse de l’effet maximal (absence d’épisodes émétiques et abstention de médicament de sauvetage pendant 24 h) a révélé une relation dose-effet linéaire pour les groupes dolasetron (P < 0.002). Le dolasetron aux doses de 100 mg (P < 0,003) et de 200 mg (P < 0,01) était supérieur au placebo. Le pourcentage des patientes sans épisode émétique augmentait de 29.3% (placebo) à 54,1 % (100 mg). Une analyse de sous-groupe montrait que l’état physique ASA (I < II), les antécédents de NVPO et du mal des transports, et la dose totale de morphine (> 55 mg associée à moins de NVPO que < 55 mg) influençaient l’incidence des symptômes émétiques mais ne changeaient pas les résultats de l’analyse pnncipale.
Conclusion
La prophylaxie au dolasetron (100 mg et 200 mg) diminue l’incidence des NVPO chez les opérées pour hystérectomie abdominale totale.
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Remaining members of the Canadian Dolasetron Study Group: J.E. Kronbergmd (Women’s College Hospital, Toronto), R.J. Hudsonmd (St. Boniface Hospital, Winnipeg), G. Plourdemd (Royal Victoria Hospital, Montreal), L. Murphymd (Vancouver General Hospital, Vancouver), F. Zahariamd (Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke), D.B. DuValmd (Misericordia Hospital, Edmonton), C. Derkzomd (St. Michael’s Hospital, Toronto), M. Juncaumd (Monacal Heart Institute, Montreal), K. McKenziemsc, S. Keaysbscn, E. Dernpseymsc (Hoechst Marion Roussd Canada Research Inc., Laval).
Supported by: Hoechst Marion Roussd Canada Research Inc., Laval, Qué. Presented at: American Society of Anesthesiologists’ Annual Meeting, October 25, 1995.
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Warriner, C.B., Knox, D., Belo, S. et al. Prophylactic oral dolasetron mesylate reduces nausea and vomiting after abdominal hysterectomy. Can J Anesth 44, 1167–1173 (1997). https://doi.org/10.1007/BF03013339
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DOI: https://doi.org/10.1007/BF03013339