Sedation vs. Intubation for Endovascular Stroke TreAtment (SIESTA) – A Randomized Monocentric Trial

Author:

Schönenberger Silvia1,Möhlenbruch Markus2,Pfaff Johannes2,Mundiyanapurath Sibu1,Kieser Meinhard3,Bendszus Martin2,Hacke Werner1,Bösel Julian1

Affiliation:

1. Department of Neurology, University of Heidelberg, Heidelberg, Germany

2. Department of Neuroradiology, University of Heidelberg, Heidelberg, Germany

3. Institute of Medical Biometry and Informatics, University of Heidelberg, Heidelberg, Germany

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). Method 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. Conclusion 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.

Publisher

SAGE Publications

Subject

Neurology

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