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Randomized Controlled Trial Multicenter Study
Dexamethasone for the treatment of established postoperative nausea and vomiting: A randomised dose finding trial.
- Christoph Czarnetzki, Eric Albrecht, Jules Desmeules, Christian Kern, Jean-Baptiste Corpataux, Sylvain Gander, van KuijkSander M JSMJ, and Martin R Tramèr.
- From the Division of Anaesthesiology, Department of Anaesthesiology, Pharmacology, Intensive Care and Emergency Medicine, Geneva University Hospitals, Geneva (CC, MRT), Division of Anaesthesiology, Department of Anaesthesiology, Intensive Care and Emergency Medicine, Ospedale Regionale di Lugano, EOC, Lugano, Switzerland (CC), Division of Clinical Pharmacology and Toxicology, Department of Anaesthesiology, Pharmacology, Intensive Care and Emergency Medicine, Geneva University Hospitals (JD), Division of Anaesthesiology, University Hospitals of Lausanne (EA, CK), Department of Clinical Epidemiology and Medical Technology Assessment, Maastricht University Medical Centre, Maastricht, the Netherlands (SMJvK), Division of Anaesthesiology, Réseau Hospitalier Neuchatelois, Neuchatel (J-BC), Division of Anaesthesiology, Etablissements Hospitaliers du Nord Vaudois, Yverdon les Bains et Saint Loup (SG), Faculty of Medicine, University of Geneva, Geneva (CC, JD, MRT) and Faculty of Biology and Medicine, University of Lausanne, Lausanne, Switzerland (EA, CK).
- Eur J Anaesthesiol. 2022 Jun 1; 39 (6): 549-557.
BackgroundDexamethasone is widely used for the prevention of postoperative nausea and vomiting (PONV) but little is known about its efficacy for the treatment of established PONV.ObjectiveTo test the antiemetic efficacy of intravenous dexamethasone for the treatment of established PONV in adults undergoing surgery under general anaesthesia and to determine whether there is dose-responsiveness.DesignThe DexPonv trial is a multicentre, placebo-controlled, randomised, double-blind, dose-finding study. Inclusion of patients was between September 2012 and November 2017. Follow-up for PONV symptoms was for 24 h. Thirty days postoperatively, patients were contacted by study nurses for any information on postoperative bleeding and infection.SettingFour public hospitals in Switzerland.PatientsA total of 803 adults scheduled for elective surgery without any antiemetic prophylaxis signed the consent form; 714 were included. Among those, 319 had PONV and 281 patients were eventually randomised (intention to treat population and safety set). The per protocol set consisted of 260 patients.InterventionsPatients with PONV symptoms (including retching) were randomised to a single intravenous dose of dexamethasone 3, 6 or 12 mg or matching placebo.Main Outcome MeasuresThe primary endpoint was the absence of further nausea or vomiting (including retching), within 24 h after administration of the study drug.ResultsDexamethasone was ineffective during the first 24 h, whatever the dosage, compared to placebo, even when the model was adjusted for known risk factors (P = 0.170). There were no differences in the time to treatment failure or the quality of sleep during the first night. There was a positive correlation between the dose of dexamethasone and blood glucose concentrations (P < 0.001), but not with bleeding risk, wound infections or other adverse effects.ConclusionThis randomised trial failed to show anti-emetic efficacy of any of the tested intravenous regimens of dexamethasone for the treatment of established PONV in adults undergoing surgery under general anaesthesia.Trial Registrationclinicaltrials.gov (NCT01975727).Copyright © 2021 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the European Society of Anaesthesiology.
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