Sedation versus general anaesthesia in endovascular therapy for anterior circulation acute ischaemic stroke: the multicentre randomised controlled AMETIS trial study protocol. Issue 9 (13th September 2019)

• Record Type: Journal Article
• Authors: Chabanne, Russell; Fernandez-Canal, Charlotte; Degos, Vincent; Lukaszewicz, Anne-Claire; Velly, Lionel; Mrozek, Segolene; Perrigault, Pierre-François; Molliex, Serge; Tavernier, Benoit; Dahyot-Fizelier, Claire; Verdonk, Franck; Caumon, Elodie; Masgrau, Aurélie; Begard, Marc; Chabert, Emmanuel; Ferrier, Anna; Jaber, Samir; Bazin, Jean-Etienne; Pereira, Bruno; Futier, Emmanuel
• Other Names: author non-byline.; Lagarde Kevin author non-byline.; Cosserant Bernard author non-byline.; Cammas Thibault author non-byline.; Pascal Julien author non-byline.; Grimaldi Florian author non-byline.; Rolhion Christine author non-byline.; Morand Dominique author non-byline.; Laroche Erwan author non-byline.; Boissy Camille author non-byline.; Grobost Romain author non-byline.; Brandely Antoine author non-byline.; Langlade Isabelle author non-byline.; Saurel Danielle author non-byline.; Vallet Laurent author non-byline.; Molinari Nicolas author non-byline.; Bourgois Nathalie author non-byline.; Moisset Xavier author non-byline.; Clavelou Pierre author non-byline.; Vitello Nicolas author non-byline.; Jean Betty author non-byline.; Zerroug Abderrahim author non-byline.; Moreno Ricardo author non-byline.; Gabrillargues Jean author non-byline.; Payen Jean-François author non-byline.; Zuber Mathieu author non-byline.; Pasqualotto Romain author non-byline.; Clarencon Frédéric author non-byline.; Torkomian Grégory author non-byline.; Battisti Valentine author non-byline.; Bapteste Lionel author non-byline.; Gemanar Anisoara author non-byline.; Mottolese Catherine author non-byline.; Silve Roxane author non-byline.; Lavabre Olivier author non-byline.; Thomas Elie author non-byline.; Baranger Violaine author non-byline.; Braud Helene author non-byline.; Lenormand Elisabeth author non-byline.; Bernstein David author non-byline.; Gilles-Baray Marie author non-byline.; Papagiannaki Chrysanthi author non-byline.; Bruder Nicolas author non-byline.; Vaisse Camille author non-byline.; Bertrandy Michele author non-byline.; Doukhan Laure author non-byline.; Cataldi Sophie author non-byline.; Verdier Valentine author non-byline.; Sanchez Didier author non-byline.; Dumont Jean-Claude author non-byline.; Geeraerts Thomas author non-byline.; Delort Francois author non-byline.; Marhar Fouad author non-byline.; Tardif Elsa author non-byline.; Rousset David author non-byline.; Larcher Claire author non-byline.; Delamarre Louis author non-byline.; Martin Charlotte author non-byline.; Osinski Diane author non-byline.; Gaussiat Francois author non-byline.; Fourcade Olivier author non-byline.; Albucher Jean-François author non-byline.; Olivot Jean-Marc author non-byline.; Calviere Lionel author non-byline.; Raposo Nicolas author non-byline.; Viguier Alain author non-byline.; Cognard Christophe author non-byline.; Bonneville Fabrice author non-byline.; Januel Anne-Christine author non-byline.; Tall Philippe author non-byline.; Michelozzi Caterina author non-byline.; Darcourt Jean author non-byline.; Parry Elodie author non-byline.; Surmont Sarah author non-byline.; Parmentier Laurie author non-byline.; Jozefowicz Elsa author non-byline.; Kazemihru Apolline author non-byline.; Henon Hilde author non-byline.; Lafanechere Aureli author non-byline.; Henry Lois author non-byline.; Magand Clément author non-byline.; Aggour Mohamed author non-byline.; Pregny Anaele author non-byline.; Bonnefoi Marlene author non-byline.; Rapido Francesca author non-byline.; Garnier Océane author non-byline.; Chalard Kevin author non-byline.; Costala Vincent author non-byline.; Ridolfo Jérome author non-byline.; Bouhaddjar Mokhtar author non-byline.; Delye Bénédicte author non-byline.; Hocquet Anne-Francoise author non-byline.; Fendeleur Julien author non-byline.; Granson Sandra author non-byline.; Lelong Anne author non-byline.; Alamowitch Sonia author non-byline.; Fellous Souad author non-byline.;
• Is Part Of: BMJ open. Volume 9:Issue 9(2019)
• Publication Date: 2019-09-13
• Subjects: stroke -- sedation -- anaesthesia in neurology -- thrombectomy; Medicine -- Research -- Periodicals; 610.72
• DOI: 10.1136/bmjopen-2018-027561
• Languages: English
• ISSNs: 2044-6055

Abstract

Abstract : Introduction: Endovascular 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 analysis: Anesthesia 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 dissemination: The 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 number: NCT03229148 .