GASS Trial study protocol a multicentre, single-blind, randomised clinical trial comparing general anaesthesia and sedation during intra-arterial treatment for stroke
| Autor: | Maurice, Axelle, Ferré, Jean-Christophe, Ronzière, Thomas, Devys, Jean-Michel, Subileau, Aurelie, Laffon, Marc, Laviolle, Bruno, Beloeil, Hélène |
|---|---|
| Přispěvatelé: | Centre d'Investigation Clinique [Rennes] (CIC), Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), Nutrition, Métabolismes et Cancer (NuMeCan), Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES), Département de Radiologie [CHU de Rennes], CHU Pontchaillou [Rennes], Fondation Ophtalmologique Adolphe de Rothschild [Paris], Hôpital de la Cavale Blanche - CHRU Brest (CHU - BREST ), Hôpital Bretonneau, Centre Hospitalier Régional Universitaire de Tours (CHRU Tours), French Ministry of Health (Programme Hospitalier de Recherche Clinique Inter regional (PHRCI 2015)., Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), Institut National de la Recherche Agronomique (INRA)-Université de Rennes (UR)-Institut National de la Santé et de la Recherche Médicale (INSERM), Université de Rennes (UR), Jonchère, Laurent, Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE) |
| Jazyk: | angličtina |
| Rok vydání: | 2019 |
| Předmět: |
Adult
Male [SDV.MHEP.CHI] Life Sciences [q-bio]/Human health and pathology/Surgery endovascular therapy neurology Endovascular Procedures Conscious Sedation [SDV.MHEP.CHI]Life Sciences [q-bio]/Human health and pathology/Surgery Anesthesia General stroke [SDV.MHEP.CSC] Life Sciences [q-bio]/Human health and pathology/Cardiology and cardiovascular system anaesthesia in neurology Anaesthesia [SDV.MHEP.CSC]Life Sciences [q-bio]/Human health and pathology/Cardiology and cardiovascular system Protocol Humans Female Single-Blind Method cardiovascular diseases adult anaesthesia |
| Zdroj: | BMJ Open BMJ Open, BMJ Publishing Group, 2019, 9 (5), pp.e024249. ⟨10.1136/bmjopen-2018-024249⟩ BMJ Open, 2019, 9 (5), pp.e024249. ⟨10.1136/bmjopen-2018-024249⟩ |
| ISSN: | 2044-6055 |
| Popis: | International audience; 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. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|