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* From the Klinik für Anästhesiologie und Operative Intensivmedizin, Universitätsklinikum Schleswig-Holstein, Campus Kiel, Germany and Department of Anesthesia and Critical Care, Massachusetts General Hospital,* Boston, Massachusetts, USA;
Klinik für Anästhesie und Intensivtherapie, Uniklinikum Marburg;
Klinik für Anästhesiologie, Intensivmedizin und Schmerztherapie, Universitätsklinikum des Saarlandes, Homburg;
GlaxoSmithKline, München; and the Klinik und Poliklinik für Anästhesiologie, Universitätsklinikum Würzburg, Germany, and Department of Anesthesiology and Perioperative Medicine, and the Outcomes ResearchTM Institute, University of Louisville, Louisville, Kentucky, USA.
Address correspondence to: Dr. Dirk Rüsch, Department of Anesthesia and Critical Care, University Hospital of Marburg, Baldingerstr., 35033 Marburg, Germany. Phone: +49 (6421) 2865981. E-mail: ruesch{at}staff.uni-marburg.de
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 Fishers exact or Students 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 and P = 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.
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