title: Sedation vs. Intubation for Endovascular Stroke TreAtment (SIESTA) - a randomized monocentric trial.
abstract: BACKGROUND
  The optimal peri-interventional management of sedation and airway for endovascular stroke treatment (EST) appears to be a crucial factor for treatment success. According to retrospective studies, the widely favored general anesthesia with intubation seems to be associated with poor functional outcome compared to a slightly sedated non-intubated condition (conscious sedation).
  
  
  METHODS
  SIESTA is a monocentric, prospective, randomized parallel-group, open-label treatment trial with blinded endpoint evaluation (PROBE design). The study compares the non-intubated with the intubated state in patients receiving endovascular treatment of acute ischemic anterior circulation stroke. The primary endpoint is early neurological improvement as by National Institutes of Health Stroke Scale (NIHSS) after 24 h (difference between NIHSS on admission and NIHSS after 24 h). Secondary endpoints include: functional outcome after three-months as by modified Rankin Scale (mRS), mortality, parameters of ventilation and critical care, feasibility, and safety, i.e. complications related to endovascular stroke treatment.
  
  
  CONCLUSIONS
  The aims of this study are to prospectively clarify whether the non-intubated state of conscious sedation is feasible, safe, and superior with regard to early neurological improvement compared to the intubated state of general anesthesia in patients receiving acute endovascular stroke treatment.
authors: Department of Neurology, University of Heidelberg, Heidelberg, Germany.
authors: Silvia
authors: S
authors: Schönenberger
authors: Department of Neuroradiology, University of Heidelberg, Heidelberg, Germany.
authors: Markus
authors: M
authors: Möhlenbruch
authors: Department of Neuroradiology, University of Heidelberg, Heidelberg, Germany.
authors: Johannes
authors: J
authors: Pfaff
authors: Department of Neurology, University of Heidelberg, Heidelberg, Germany.
authors: Sibu
authors: S
authors: Mundiyanapurath
authors: Institute of Medical Biometry and Informatics, University of Heidelberg, Heidelberg, Germany.
authors: Meinhard
authors: M
authors: Kieser
authors: Department of Neuroradiology, University of Heidelberg, Heidelberg, Germany.
authors: Martin
authors: M
authors: Bendszus
authors: Department of Neurology, University of Heidelberg, Heidelberg, Germany.
authors: Werner
authors: W
authors: Hacke
authors: Department of Neurology, University of Heidelberg, Heidelberg, Germany.
authors: Julian
authors: J
authors: Bösel
mesh_terms: D002545:Brain Ischemia / Q000188:drug therapy / Q000601:surgery*; D016292:Procedural Sedation / Q000009:adverse effects / Q000379:methods; D057510:Endovascular Procedures / Q000009:adverse effects / Q000379:methods*; D005240:Feasibility Studies; D005500:Follow-Up Studies; D006801:Humans; D007440:Intubation / Q000009:adverse effects / Q000379:methods; D019635:Neurosurgical Procedures / Q000009:adverse effects / Q000379:methods*; D011446:Prospective Studies; D016037:Single-Blind Method; D020521:Stroke / Q000188:drug therapy / Q000601:surgery*
keywords: acute ischemic stroke; conscious sedation; endovascular stroke treatment; general anesthesia; intraarterial thrombolysis; mechanical thrombectomy