GASS Trial study protocol: a multicentre, single-blind, randomised clinical trial comparing general anaesthesia and sedation during intra-arterial treatment for stroke. Issue 5 (1st June 2019)

• Record Type: Journal Article
• Authors: Maurice, Axelle; Ferré, Jean-Christophe; Ronzière, Thomas; Devys, Jean-Michel; Subileau, Aurelie; Laffon, Marc; Laviolle, Bruno; Beloeil, Helene
• Is Part Of: BMJ open. Volume 9:Issue 5(2019)
• Publication Date: 2019-06-01
• Subjects: stroke -- endovascular therapy -- anaesthesia in neurology -- adult anaesthesia -- neurology; Medicine -- Research -- Periodicals; 610.72
• DOI: 10.1136/bmjopen-2018-024249
• Languages: English
• ISSNs: 2044-6055

Abstract

Abstract : Introduction: 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. Methods/analysis: 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. Ethics/dissemination: 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. Trial registration number: NCT02822144 .