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

  • Samir Jaber,
  • Emmanuel Futier,
  • Anne-Christine Januel,
  • Mohamed Aggour,
  • Emmanuel Chabert,
  • Nicolas Molinari,
  • Nicolas Bruder,
  • Thomas Geeraerts,
  • Claire Dahyot-fizelier,
  • Christophe Cognard,
  • Mathieu Zuber,
  • Hilde Henon,
  • Russell Chabanne,
  • Charlotte Fernandez-Canal,
  • Vincent Degos,
  • Anne-Claire Lukaszewicz,
  • Lionel Velly,
  • Segolene Mrozek,
  • Pierre-François Perrigault,
  • Benoit Tavernier,
  • Franck Verdonk,
  • Elodie Caumon,
  • Aurélie Masgrau,
  • Marc Begard,
  • Anna Ferrier,
  • Kevin Lagarde,
  • Bernard Cosserant,
  • Thibault Cammas,
  • Julien Pascal,
  • Florian Grimaldi,
  • Christine Rolhion,
  • Dominique Morand,
  • Erwan Laroche,
  • Camille Boissy,
  • Romain Grobost,
  • Antoine Brandely,
  • Isabelle Langlade,
  • Danielle Saurel,
  • Laurent Vallet,
  • Nathalie Bourgois,
  • Xavier Moisset,
  • Pierre Clavelou,
  • Nicolas Vitello,
  • Betty Jean,
  • Abderrahim Zerroug,
  • Ricardo Moreno,
  • Jean Gabrillargues,
  • Jean-François Payen,
  • Romain Pasqualotto,
  • Grégory Torkomian,
  • Valentine Battisti,
  • Lionel Bapteste,
  • Anisoara Gemanar,
  • Catherine Mottolese,
  • Roxane Silve,
  • Olivier Lavabre,
  • Elie Thomas,
  • Violaine Baranger,
  • Helene Braud,
  • Elisabeth Lenormand,
  • David Bernstein,
  • Marie Gilles-Baray,
  • Chrysanthi Papagiannaki,
  • Camille Vaisse,
  • Michele Bertrandy,
  • Laure Doukhan,
  • Sophie Cataldi,
  • Valentine Verdier,
  • Didier Sanchez,
  • Jean-Claude Dumont,
  • Francois Delort,
  • Fouad Marhar,
  • Elsa Tardif,
  • David Rousset,
  • Claire Larcher,
  • Louis Delamarre,
  • Charlotte Martin,
  • Diane Osinski,
  • Francois Gaussiat,
  • Olivier Fourcade,
  • Jean-François Albucher,
  • Jean-Marc Olivot,
  • Lionel Calviere,
  • Nicolas Raposo,
  • Alain Viguier,
  • Fabrice Bonneville,
  • Philippe Tall,
  • Caterina Michelozzi,
  • Jean Darcourt,
  • Elodie Parry,
  • Sarah Surmont,
  • Laurie Parmentier,
  • Elsa Jozefowicz,
  • Apolline Kazemihru,
  • Aureli Lafanechere,
  • Lois Henry,
  • Clément Magand,
  • Anaele Pregny,
  • Marlene Bonnefoi,
  • Francesca Rapido,
  • Océane Garnier,
  • Kevin Chalard,
  • Vincent Costala,
  • Jérome Ridolfo,
  • Mokhtar Bouhaddjar,
  • Bénédicte Delye,
  • Anne-Francoise Hocquet,
  • Julien Fendeleur,
  • Sandra Granson,
  • Anne Lelong,
  • Sonia Alamowitch,
  • Souad Fellous

DOI
https://doi.org/10.1136/bmjopen-2018-027561
Journal volume & issue
Vol. 9, no. 9

Abstract

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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.