GASS Trial study protocol: a multicentre, single-blind, randomised clinical trial comparing general anaesthesia and sedation during intra-arterial treatment for stroke.


Journal

BMJ open
ISSN: 2044-6055
Titre abrégé: BMJ Open
Pays: England
ID NLM: 101552874

Informations de publication

Date de publication:
01 06 2019
Historique:
entrez: 3 6 2019
pubmed: 4 6 2019
medline: 22 4 2020
Statut: epublish

Résumé

Treatment of acute stroke has drastically changed in the last 10 years. Endovascular therapy is now the standard of care for patients with a stroke caused by a large vessel occlusion in the anterior circulation. The impact of the type of anaesthesia (general anaesthesia or conscious sedation) during endovascular therapy on the outcome of the patients is still a matter of debate. Previous studies are mostly retrospective and/or focused on the early postprocedure outcome and/or without blood pressure goals and/or single-centre small size studies. We therefore designed a multicentre study hypothesising that conscious sedation is associated with a better functional outcome 3 months after endovascular therapy for the treatment of stroke compared with general anaesthesia. The General Anesthesia vs Sedation for Stroke (GASS) Trial is a randomised, parallel, single-blind, multicentre study of 350 patients undergoing endovascular therapy for the treatment of stroke. Patients will be randomly allocated to receive either a general anaesthesia or a conscious sedation. The primary outcome measure is the modified Rankin score assessed 3 months after the treatment. Data will be analysed on the intention-to-treat principle. The GASS Trial has been approved by an independent ethics committee for all study centres. Participant recruitment begins in September 2016. Results will be published in international peer-reviewed medical journals. NCT02822144.

Identifiants

pubmed: 31154292
pii: bmjopen-2018-024249
doi: 10.1136/bmjopen-2018-024249
pmc: PMC6550003
doi:

Banques de données

ClinicalTrials.gov
['NCT02822144']

Types de publication

Clinical Trial Protocol Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

e024249

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.

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Auteurs

Axelle Maurice (A)

CHU Rennes, Pôle Anesthésie et Réanimation, Inserm, NuMeCan, CIC 1414 and Université de Rennes 1, Rennes, France.

Jean-Christophe Ferré (JC)

Department of Neuroradiology, CHU Rennes, Rennes, France.

Thomas Ronzière (T)

Department of Neurology, CHU Rennes, Rennes, France.

Jean-Michel Devys (JM)

Service d'Anesthésie-Réanimation, Fondation Ophtalmologique, Paris, France.

Aurelie Subileau (A)

Service d'Anesthésie Réanimation, CHRU La Cavale Blanche, Brest, France.

Marc Laffon (M)

Service d'Anesthésie Réanimation 1, CHU Hôpital Bretonneau, Tours, France.

Bruno Laviolle (B)

CHU Rennes, Clinical Pharmacology department and Inserm CIC 1414, Université de Rennes 1, Rennes, France.

Helene Beloeil (H)

CHU Rennes, Pôle Anesthésie et Réanimation, Inserm, NuMeCan, CIC 1414 and Université de Rennes 1, Rennes, France.

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