Sedation vs. Intubation for Endovascular Stroke TreAtment (SIESTA)
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ClinicalTrials.gov Identifier: NCT02126085 |
Recruitment Status :
Completed
First Posted : April 29, 2014
Last Update Posted : May 24, 2016
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Condition or disease | Intervention/treatment | Phase |
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Acute Ischemic Stroke | Procedure: Endovascular recanalisation | Not Applicable |
Early recanalization is an important, if not the most important, factor concerning reconstitution of patients´ health in ischaemic stroke. This is the reason why patients with extended stroke are increasingly subjected to an endovascular stroke therapy (EST).
Matter of ongoing debate is how to sedate these patients during intervention. Some clinicians prefer an intubation due to a reduction of patients´movements and therefore potentially lowering complication rates (injury by catheter, aspiration e.g.).
On the other hand retrospective investigations hypothesize that general anaesthesia is associated with peri-interventional hypotension followed by poorer clinical outcome.
The best anaesthaesiologic management in endovascular stroke therapy to this point of time is not known. The investigators therefore designed this study comparing intubated state with general anaesthesia vs. non-intubated state with conscious sedation during EST, focusing on patients´ outcome.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 150 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Sedation vs. Intubation for Endovascular Stroke TreAtment |
Study Start Date : | April 2014 |
Actual Primary Completion Date : | February 2016 |
Actual Study Completion Date : | May 2016 |

Arm | Intervention/treatment |
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Active Comparator: Intubation
Intubation and invasive mechanical ventilation + endovascular recanalisation
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Procedure: Endovascular recanalisation
Endovascular recanalisation by mechanical thrombectomy with e.g. stent retriever device, possibly following intravenous thrombolysis within a "bridging concept" |
Experimental: No Intubation
Conscious sedation and non-invasive ventilatory support + endovascular recanalisation
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Procedure: Endovascular recanalisation
Endovascular recanalisation by mechanical thrombectomy with e.g. stent retriever device, possibly following intravenous thrombolysis within a "bridging concept" |
- National Institutes of Health Stroke Scale (NIHSS) after 24 hours [ Time Frame: 24 hours ]Neurological improvement of NIHSS 24 hours after intervention
- Outcome after 3 month using the modified Rankin Scale (mRS) [ Time Frame: 3 month ]Assessing the neurological outcome after 3 months with the mRS.
- Inpatient-mortality [ Time Frame: Mortality-rate until timepoint of discharge, an expected average of 3 weeks. ]
- Mortality-rate within the first 3 months after intervention. [ Time Frame: First 3 months after intervention ]
- Duration of hospital stay [ Time Frame: Participants will be followed until timepoint of discharge, an expected average of 3 weeks. ]
- Periinterventional complications [ Time Frame: Evaluation of Adverse Events as a Measure of Safety and Tolerability until timepoint of discharge, an expected average of 3 weeks. ]
- Achieved recanalisation grade [ Time Frame: Duration of intervention with an expected average of 2 hours ]Recanalisation status is classified according to the Thrombolysis in Cerebral Infarction classification (TICI).

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- age ≥18 years
- acute stroke in anterior circulation
- occlusion of carotid artery and/ or middle cerebral artery
- planned mechanical recanalisation
- informed consent from patient or legal representative
Exclusion Criteria:
- age < 18 years
- informed consent not obtainable
- coma
- agitation
- vomiting
- difficult airway management
- additional cerebral hemorrhage

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02126085
Germany | |
Department of Neurology, University Hospital Heidelberg | |
Heidelberg, Baden-Württemberg, Germany, 69120 |
Principal Investigator: | Julian Bösel, PD | Department of Neurology, University Hospital Heidelberg |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Dr. Silvia Schönenberger, MD, Leading sub-investigator, Principal Investigator: PD Dr. Julian Bösel, MD, University Hospital Heidelberg |
ClinicalTrials.gov Identifier: | NCT02126085 |
Other Study ID Numbers: |
SIESTA |
First Posted: | April 29, 2014 Key Record Dates |
Last Update Posted: | May 24, 2016 |
Last Verified: | May 2016 |
ischemic stroke recanalisation sedation |
Stroke Ischemic Stroke Cerebrovascular Disorders Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases |