Sedation versus general anaesthesia in endovascular therapy for anterior circulation acute ischaemic stroke: the multicentre randomised controlled AMETIS trial study protocol.
anaesthesia in neurology
sedation
stroke
thrombectomy
Journal
BMJ open
ISSN: 2044-6055
Titre abrégé: BMJ Open
Pays: England
ID NLM: 101552874
Informations de publication
Date de publication:
13 09 2019
13 09 2019
Historique:
entrez:
15
9
2019
pubmed:
15
9
2019
medline:
26
9
2020
Statut:
epublish
Résumé
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. 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. 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. NCT03229148.
Identifiants
pubmed: 31519668
pii: bmjopen-2018-027561
doi: 10.1136/bmjopen-2018-027561
pmc: PMC6747652
doi:
Banques de données
ClinicalTrials.gov
['NCT03229148']
Types de publication
Clinical Trial Protocol
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
e027561Investigateurs
Kevin Lagarde
(K)
Bernard Cosserant
(B)
Thibault Cammas
(T)
Julien Pascal
(J)
Florian Grimaldi
(F)
Christine Rolhion
(C)
Dominique Morand
(D)
Erwan Laroche
(E)
Camille Boissy
(C)
Romain Grobost
(R)
Antoine Brandely
(A)
Isabelle Langlade
(I)
Danielle Saurel
(D)
Laurent Vallet
(L)
Nicolas Molinari
(N)
Nathalie Bourgois
(N)
Xavier Moisset
(X)
Pierre Clavelou
(P)
Nicolas Vitello
(N)
Betty Jean
(B)
Abderrahim Zerroug
(A)
Ricardo Moreno
(R)
Jean Gabrillargues
(J)
Jean-François Payen
(JF)
Mathieu Zuber
(M)
Romain Pasqualotto
(R)
Frédéric Clarencon
(F)
Grégory Torkomian
(G)
Valentine Battisti
(V)
Lionel Bapteste
(L)
Anisoara Gemanar
(A)
Catherine Mottolese
(C)
Roxane Silve
(R)
Olivier Lavabre
(O)
Elie Thomas
(E)
Violaine Baranger
(V)
Helene Braud
(H)
Elisabeth Lenormand
(E)
David Bernstein
(D)
Marie Gilles-Baray
(M)
Chrysanthi Papagiannaki
(C)
Nicolas Bruder
(N)
Camille Vaisse
(C)
Michele Bertrandy
(M)
Laure Doukhan
(L)
Sophie Cataldi
(S)
Valentine Verdier
(V)
Didier Sanchez
(D)
Jean-Claude Dumont
(JC)
Thomas Geeraerts
(T)
Francois Delort
(F)
Fouad Marhar
(F)
Elsa Tardif
(E)
David Rousset
(D)
Claire Larcher
(C)
Louis Delamarre
(L)
Charlotte Martin
(C)
Diane Osinski
(D)
Francois Gaussiat
(F)
Olivier Fourcade
(O)
Jean-François Albucher
(JF)
Jean-Marc Olivot
(JM)
Lionel Calviere
(L)
Nicolas Raposo
(N)
Alain Viguier
(A)
Christophe Cognard
(C)
Fabrice Bonneville
(F)
Anne-Christine Januel
(AC)
Philippe Tall
(P)
Caterina Michelozzi
(C)
Jean Darcourt
(J)
Elodie Parry
(E)
Sarah Surmont
(S)
Laurie Parmentier
(L)
Elsa Jozefowicz
(E)
Apolline Kazemihru
(A)
Hilde Henon
(H)
Aureli Lafanechere
(A)
Lois Henry
(L)
Clément Magand
(C)
Mohamed Aggour
(M)
Anaele Pregny
(A)
Marlene Bonnefoi
(M)
Francesca Rapido
(F)
Océane Garnier
(O)
Kevin Chalard
(K)
Vincent Costala
(V)
Jérome Ridolfo
(J)
Mokhtar Bouhaddjar
(M)
Bénédicte Delye
(B)
Anne-Francoise Hocquet
(AF)
Julien Fendeleur
(J)
Sandra Granson
(S)
Anne Lelong
(A)
Sonia Alamowitch
(S)
Souad Fellous
(S)
Informations de copyright
© 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.
Déclaration de conflit d'intérêts
Competing interests: None declared.
Références
Anesthesiology. 2002 Apr;96(4):1004-17
pubmed: 11964611
Am J Respir Crit Care Med. 2002 Nov 15;166(10):1338-44
pubmed: 12421743
Am J Epidemiol. 2003 May 15;157(10):940-3
pubmed: 12746247
Am J Epidemiol. 2004 Aug 15;160(4):301-5
pubmed: 15286014
Stroke. 2006 Feb;37(2):556-61
pubmed: 16397182
Ann Fr Anesth Reanim. 2006 Jul;25(7):696-701
pubmed: 16698231
BMJ. 2010 Mar 23;340:c332
pubmed: 20332509
CMAJ. 2012 May 15;184(8):895-9
pubmed: 22158397
Anesthesiology. 2012 Feb;116(2):396-405
pubmed: 22222475
Stroke. 2012 Apr;43(4):1163-70
pubmed: 22426313
Stroke. 2012 Apr;43(4):1171-8
pubmed: 22426314
BMJ. 2013 Jan 08;346:e7586
pubmed: 23303884
Stroke. 2013 Sep;44(9):2650-63
pubmed: 23920012
Eur J Anaesthesiol. 2015 Feb;32(2):88-105
pubmed: 25058504
N Engl J Med. 2015 Jan 1;372(1):11-20
pubmed: 25517348
Neurocrit Care. 2015 Feb;22(1):146-64
pubmed: 25605626
N Engl J Med. 2015 Mar 12;372(11):1009-18
pubmed: 25671797
N Engl J Med. 2015 Mar 12;372(11):1019-30
pubmed: 25671798
N Engl J Med. 2015 Jun 11;372(24):2285-95
pubmed: 25882376
N Engl J Med. 2015 Jun 11;372(24):2347-9
pubmed: 25882509
N Engl J Med. 2015 Jun 11;372(24):2296-306
pubmed: 25882510
Stroke. 2015 Oct;46(10):3020-35
pubmed: 26123479
Stroke Res Treat. 2016;2016:9482876
pubmed: 27088036
Curr Opin Anaesthesiol. 2016 Oct;29(5):568-75
pubmed: 27455043
Stroke. 1989 Jul;20(7):864-70
pubmed: 2749846
Lancet Neurol. 2016 Oct;15(11):1138-47
pubmed: 27567239
JAMA. 2016 Nov 15;316(19):1986-1996
pubmed: 27785516
Anesthesiology. 2017 Jun;126(6):1187-1199
pubmed: 28383324
Int J Stroke. 2017 Dec;12(9):991-997
pubmed: 28436307
Stroke. 2017 Jun;48(6):1601-1607
pubmed: 28522637
Front Neurol. 2017 Jun 19;8:274
pubmed: 28674514
Curr Opin Anaesthesiol. 2017 Oct;30(5):563-569
pubmed: 28723732
N Engl J Med. 2018 Jan 4;378(1):11-21
pubmed: 29129157
Lancet Neurol. 2018 Jan;17(1):21-23
pubmed: 29262998
JAMA Neurol. 2018 Apr 1;75(4):470-477
pubmed: 29340574
N Engl J Med. 2018 Feb 22;378(8):708-718
pubmed: 29364767
Stroke. 2018 Mar;49(3):e46-e110
pubmed: 29367334
Stroke. 1988 May;19(5):604-7
pubmed: 3363593