Abstract
Purpose
To compare the risk-adapted approach with ondansetron against ondansetron plus dexamethasone to prevent postoperative nausea and vomiting (PONV) in a randomized clinical trial.
Methods
460 patients scheduled for elective surgery were enrolled in this prospective study and stratified according to a simplified risk score for PONV. Patients having no or one risk factor were considered at low risk (group L) and did not receive study medication. Those with two to four risk factors were considered high risk and were randomized to receive 4 mg ondansetron plus placebo (group H-O) or 4 mg ondansetron plus 8 mg dexamethasone (group H-OD). Incidence and intensity of PONV were observed for 24 hr after surgery. Data were analyzed with Fisher’s exact or Student’s t tests;P < 0.05 was considered statistically significant.
Results
The incidence of PONV was 9% in group L (n = 87), 31% in those receiving ondansetron (group H-O,n = 185), and 22% in those receiving both drugs (group H-OD,n = 181). The incidence of PONV was significantly smaller in both high-risk groups than predicted without treatment (P < 0.001). While the incidence of PONV failed statistical significance between the two intervention groups (P = 0.08), the mean number of episodes of PONV and the mean maximal intensity of each episode of PONV were lower in group H-OD (P = 0.03 andP = 0.01, respectively). Patients of group H-OD required less antiemetic rescue therapy (P = 0.004). Conclusions: Ondansetron plus dexamethasone prevents PONV more effectively than ondansetron alone in patients at high risk for PONV.
Résumé
Objectif
Comparer l’approche adaptée au risque avec ondansétron ou avec ondansétron et dexaméthasone pour prévenir les nausées et vomissements postopératoires (NVPO) dans une étude clinique randomisée.
Méthode
L’étude prospective a porté sur 460 patients, devant subir une intervention chirurgicale réglée, qui ont été stratifiés selon un score de risque simplifié de NVPO. Les patients ont été considérés à faible risque (groupe F) s’ils n’avaient aucun ou un facteur de risque et n’ont pas reçu la médication à l’étude. S’ils avaient de deux à quatre facteurs de risque, on les considérait à haut risque et ils recevaient au hasard 4 mg d’ondansétron plus un placebo (groupe H-O) ou 4 mg d’ondansétron plus 8 mg de dexaméthasone (groupe H-OD). L’incidence et l’intensité des NVPO ont été observées pendant 24 h après l’opération. Les données ont été analysées par les tests exact de Fisher ou t de Student ; P < 0,05 était statistiquement significatif.
Résultats
L’incidence de NVPO a été de 9 % dans le groupe F (n = 87), 31 % avec l’ondansétron (groupe H-O, n = 185) et 22 % avec les deux médicaments (groupe H-OD, n = 181). L’incidence de NVPO a été significativement plus basse dans les deux groupes à haut risque que ce qui avait été prédit sans traitement (P < 0,001). Même si l’incidence de NVPO n’était pas statistiquement significative entre les deux groupes expérimentaux (P = 0,08), le nombre moyen d’épisodes de NVPO et l’intensité maximale moyenne de chacun ont été plus faibles dans le groupe H-OD (P = 0,03 et P = 0,01, respectivement). Les patients du groupe H-OD ont demandé moins d’antiémétiques de secours P = 0,004).
Conclusion
L’ondansétron plus la dexaméthasone préviennent les NVPO plus efficacement que l’ondansétron seul chez des patients à haut risque de NVPO.
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Disclosure: This study was funded by GlaxoSmithKline, Germany.
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Rüsch, D., Eberhart, L., Biedler, A. et al. Prospective application of a simplified risk score to prevent postoperative nausea and vomiting. Can J Anesth 52, 478–484 (2005). https://doi.org/10.1007/BF03016526
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DOI: https://doi.org/10.1007/BF03016526