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Randomized Controlled Trial Comparative Study
Sedation vs. Intubation for Endovascular Stroke TreAtment (SIESTA) - a randomized monocentric trial.
- Silvia Schönenberger, Markus Möhlenbruch, Johannes Pfaff, Sibu Mundiyanapurath, Meinhard Kieser, Martin Bendszus, Werner Hacke, and Julian Bösel.
- Department of Neurology, University of Heidelberg, Heidelberg, Germany.
- Int J Stroke. 2015 Aug 1; 10 (6): 969-78.
BackgroundThe 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).MethodSIESTA 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.ConclusionThe 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.© 2015 World Stroke Organization.
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