Sedation vs. Intubation for Endovascular Stroke TreAtment (SIESTA) - a randomized monocentric trial

Int J Stroke. 2015 Aug;10(6):969-78. doi: 10.1111/ijs.12488. Epub 2015 Apr 12.

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.

Keywords: acute ischemic stroke; conscious sedation; endovascular stroke treatment; general anesthesia; intraarterial thrombolysis; mechanical thrombectomy.

Publication types

  • Comparative Study
  • Randomized Controlled Trial

MeSH terms

  • Brain Ischemia / drug therapy
  • Brain Ischemia / surgery*
  • Conscious Sedation* / adverse effects
  • Conscious Sedation* / methods
  • Endovascular Procedures / adverse effects
  • Endovascular Procedures / methods*
  • Feasibility Studies
  • Follow-Up Studies
  • Humans
  • Intubation* / adverse effects
  • Intubation* / methods
  • Neurosurgical Procedures / adverse effects
  • Neurosurgical Procedures / methods*
  • Prospective Studies
  • Single-Blind Method
  • Stroke / drug therapy
  • Stroke / surgery*