Clinical trial NCT02126085: Sedation vs. Intubation for Endovascular Stroke TreAtment
Official title: Sedation vs. Intubation for Endovascular Stroke TreAtment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Ischemic Stroke
Keywords: ischemic stroke
recanalisation
sedation
Lead sponsor: University Hospital Heidelberg
Sponsor class: OTHER
First posted: 2014-04-29
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Sedation vs Intubation for Endovascular Stroke TreAtment Trial (SIESTA) is a prospective, randomised controlled, monocentric, two-armed, comparative trial. Patients are randomized 1 : 1 to either non-intubated state or to intubated state for endovascular stroke treatment. Otherwise, no principal differences in intensive care treatment are intended, and standard operating procedures are applied to ensure uniform management decisions in fields such as ventilation, sedation, cardio-vascular and cerebral monitoring and management.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: National Institutes of Health Stroke Scale (NIHSS) after 24 hours
timeFrame: 24 hours
Secondary outcomes:
measure: Outcome after 3 month using the modified Rankin Scale (mRS)
timeFrame: 3 month
measure: Inpatient-mortality
timeFrame: Mortality-rate until timepoint of discharge, an expected average of 3 weeks.
measure: Mortality-rate within the first 3 months after intervention.
timeFrame: First 3 months after intervention
Other outcomes:
measure: Duration of hospital stay
timeFrame: Participants will be followed until timepoint of discharge, an expected average of 3 weeks.
measure: Periinterventional complications
timeFrame: Evaluation of Adverse Events as a Measure of Safety and Tolerability until timepoint of discharge, an expected average of 3 weeks.
measure: Achieved recanalisation grade
timeFrame: Duration of intervention with an expected average of 2 hours
Locations:
city: Heidelberg
country: Germany
facility: Department of Neurology, University Hospital Heidelberg
state: Baden-Württemberg
Study officials:
affiliation: Department of Neurology, University Hospital Heidelberg
name: Julian Bösel, PD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Tosello R, Riera R, Tosello G, Clezar CN, Amorim JE, Vasconcelos V, Joao BB, Flumignan RL. Type of anaesthesia for acute ischaemic stroke endovascular treatment. Cochrane Database Syst Rev. 2022 Jul 20;7(7):CD013690. doi: 10.1002/14651858.CD013690.pub2.
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