Dexamethasone for the treatment of established postoperative nausea and vomiting: A randomised dose finding trial

Article Article scientifique Article Dexamethasone for the treatment of established postoperative nausea and vomiting: A randomised dose finding trial eng 2021-11-16 2022 author Czarnetzki Christoph 45273 author Albrecht Eric author Desmeules Jules Alexandre 73542 author Kern Christian 63140 author Corpataux Jean-Baptiste 97281 author Gander Sylvain author Kuijk Sander M J van author Tramer Martin 124140 549-557 10.1097/EJA.0000000000001636 34799501 0265-0215 https://journals.lww.com/ejanaesthesiology/Fulltext/2022/06000/Dexamethasone_for_the_treatment_of_established.8.aspx Background: Dexamethasone 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. Objective: To 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. Design: The 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. Setting: Four public hospitals in Switzerland. Patients: A 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. Interventions: Patients with PONV symptoms (including retching) were randomised to a single intravenous dose of dexamethasone 3, 6 or 12 mg or matching placebo. Main outcome measures: The primary endpoint was the absence of further nausea or vomiting (including retching), within 24 h after administration of the study drug. Results: Dexamethasone 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. Conclusion: This 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 registration: clinicaltrials.gov (<a href="http://clinicaltrials.gov/show/NCT01975727" rel="noopener noreferrer" target="_blank">NCT01975727</a>). Adult Anesthesia, General / adverse effects Antiemetics Dexamethasone Double-Blind Method Humans Postoperative Nausea and Vomiting / diagnosis Postoperative Nausea and Vomiting / drug therapy Postoperative Nausea and Vomiting / epidemiology Dewey 617 Swiss National Science Foundation Dexamethasone for the treatment of established postoperative nausea and vomiting - a randomised, placebo-controlled, dose-finding study 32003B_140783 CH Project funding Clinical Research Centre, Geneva University Hospitals 130301-CD Division of Anaesthesiology, Ospedale Regionale di Lugano, Lugano, Switzerland 108.99001 63 Département d'anesthésiologie, pharmacologie, soins intensifs et urgences 229 false 302 Groupe Desmeules Jules (pharmacologie/toxicologie) 567 47 La médecine périopératoire et l'anesthésie 70 https://clinicaltrials.gov/ct2/show/NCT01975727 European journal of anaesthesiology 39 6 358037b1-6d09-4ea9-8893-bfddf8df25f5 Article (Published version) Public Dexamethasone_for_the_treatment_of_1.pdf 722526 application/pdf CC BY-NC-ND-4.0 8ab0b1ec-8ca4-4d4b-8047-39093b8259d8 Supplemental data Public eja_2021_11_13_czarnetzki_eja-d-21-.docx 17076 application/vnd.openxmlformats-officedocument.wordprocessingml.document Supplemental table 1 acb38025-a577-4b74-ad0b-7a43e1d9942f Supplemental data Public eja_2021_11_13_czarnetzki_eja-d-21-2.docx 18567 application/vnd.openxmlformats-officedocument.wordprocessingml.document Supplemental table 2 openAccess Faculté de médecine / Section de médecine clinique / Département d'anesthésiologie, pharmacologie, soins intensifs et urgences

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Dexamethasone for the treatment of established postoperative nausea and vomiting: A randomised dose finding trial	European journal of anaesthesiology			2022	375	404

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Corpataux, Jean-Baptiste