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GASS Trial study protocol: a multicentre, single-blind, randomised clinical trial comparing general anaesthesia and sedation during intra-arterial treatment for stroke
  1. Axelle Maurice1,
  2. Jean-Christophe Ferré2,
  3. Thomas Ronzière3,
  4. Jean-Michel Devys4,
  5. Aurelie Subileau5,
  6. Marc Laffon6,
  7. Bruno Laviolle7,
  8. Helene Beloeil1
  9. on behalf of the SFAR research network
  1. 1 CHU Rennes, Pôle Anesthésie et Réanimation, Inserm, NuMeCan, CIC 1414 and Université de Rennes 1, Rennes, France
  2. 2 Department of Neuroradiology, CHU Rennes, Rennes, France
  3. 3 Department of Neurology, CHU Rennes, Rennes, France
  4. 4 Service d’Anesthésie-Réanimation, Fondation Ophtalmologique, Paris, France
  5. 5 Service d’Anesthésie Réanimation, CHRU La Cavale Blanche, Brest, France
  6. 6 Service d’Anesthésie Réanimation 1, CHU Hôpital Bretonneau, Tours, France
  7. 7 CHU Rennes, Clinical Pharmacology department and Inserm CIC 1414, Université de Rennes 1, Rennes, France
  1. Correspondence to Professor Helene Beloeil; helene.beloeil{at}chu-rennes.fr

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.

  • stroke
  • endovascular therapy
  • anaesthesia in neurology
  • adult anaesthesia
  • neurology

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Footnotes

  • Contributors AM as anaesthetist contributed to the conception and design of the research protocol and wrote the research protocol. AM wrote the first draft of the protocol. AM critically revised and modified the protocol and the article. AM is including patients in the ongoing study in the Rennes teaching hospital. AM approved the final version to be published. J-CF as neuroradiologist contributed to the conception and design of the research protocol. J-CF critically revised and modified the protocol and the article. J-CF approved the final version to be published. TR as neurologist contributed to the conception and design of the research protocol. TR critically revised and modified the protocol and the article. TR approved the final version to be published. J-MD as anaesthetist critically revised and modified the protocol and the article. J-MD is including patients in the ongoing study in the Fondation Rothschild hospital in Paris. J-MD approved the final version to be published. AS as anaesthetist critically revised and modified the protocol and the article. AS is including patients in the ongoing study in the Brest teaching hospital. AS approved the final version to be published. ML as anaesthetist critically revised and modified the protocol and the article. ML is including patients in the ongoing study in the Tours teaching hospital. ML approved the final version to be published. BL designed the study and its statistical analysis plan. HB provided critical input pertaining to the design of the trial interventions and procedures. HB wrote this manuscript. HB is including patients in the ongoing study in the Rennes teaching hospital.

  • Funding GASS trial is supported by funding from French Ministry of Health (Programme Hospitalier de Recherché Clinique Inter regional (PHRCI 2015). CHU de Rennes, Direction de la recherché Clinique, 2 avenue Henri Le Guilloux, 35033 Rennes Cedex, France.

  • Competing interests None declared.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Patient consent for publication Not required.

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