• BMJ open · Sep 2019

    Sedation versus general anaesthesia in endovascular therapy for anterior circulation acute ischaemic stroke: the multicentre randomised controlled AMETIS trial study protocol.

    • Russell Chabanne, Charlotte Fernandez-Canal, Vincent Degos, Anne-Claire Lukaszewicz, Lionel Velly, Segolene Mrozek, Pierre-François Perrigault, Serge Molliex, Benoit Tavernier, Claire Dahyot-Fizelier, Franck Verdonk, Elodie Caumon, Aurélie Masgrau, Marc Begard, Emmanuel Chabert, Anna Ferrier, Samir Jaber, Jean-Etienne Bazin, Bruno Pereira, Emmanuel Futier, and ANARLF Network and the AMETIS study group.
    • Department of Perioperative Medicine, Centre Hospitalier Universitaire de Clermont-Ferrand, Clermont-Ferrand, France rchabanne@chu-clermontferrand.fr.
    • BMJ Open. 2019 Sep 13; 9 (9): e027561.

    IntroductionEndovascular thrombectomy is the standard of care for anterior circulation acute ischaemic stroke (AIS) secondary to emergent large vessel occlusion in patients who qualify. General anaesthesia (GA) or conscious sedation (CS) is usually required to ensure patient comfort and avoid agitation and movement during thrombectomy. However, the question of whether the use of GA or CS might influence functional outcome remains debated. Indeed, conflicting results exist between observational studies with better outcomes associated with CS and small monocentric randomised controlled trials favouring GA. Therefore, we aim to evaluate the effect of CS versus GA on functional outcome and periprocedural complications in endovascular mechanical thrombectomy for anterior circulation AIS.Methods And AnalysisAnesthesia Management in Endovascular Therapy for Ischemic Stroke (AMETIS) trial is an investigator initiated, multicentre, prospective, randomised controlled, two-arm trial. AMETIS trial will randomise 270 patients with anterior circulation AIS in a 1:1 ratio, stratified by centre, National Institutes of Health Stroke Scale (≤15 or >15) and association of intravenous thrombolysis or not to receive either CS or GA. The primary outcome is a composite of functional independence at 3 months and absence of perioperative complication occurring by day 7 after endovascular therapy for anterior circulation AIS. Functional independence is defined as a modified Rankin Scale score of 0-2 by day 90. Perioperative complications are defined as intervention-associated arterial perforation or dissection, pneumonia or myocardial infarction or cardiogenic acute pulmonary oedema or malignant stroke evolution occurring by day 7.Ethics And DisseminationThe AMETIS trial was approved by an independent ethics committee. Study began in august 2017. Results will be published in an international peer-reviewed medical journal.Trial Registration NumberNCT03229148.© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

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