Sedation vs. Intubation for Endovascular Stroke TreAtment

Acute Ischemic Stroke Clinical Trial

— SIESTA  

Official title:

Sedation vs. Intubation for Endovascular Stroke TreAtment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02126085
• Other study ID #: SIESTA
• Status: Completed
• Phase: N/A
• First received: April 23, 2014
• Last updated: May 22, 2016
• Start date: April 2014
• Est. completion date: May 2016

Study information

• Verified date: May 2016
• Source: University Hospital Heidelberg
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: May 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Stroke

Intervention

Procedure:
• Endovascular recanalisation
Endovascular recanalisation by mechanical thrombectomy with e.g. stent retriever device, possibly following intravenous thrombolysis within a "bridging concept"

Locations

Country	Name	City	State
Germany	Department of Neurology, University Hospital Heidelberg	Heidelberg	Baden-Württemberg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Heidelberg

Country where clinical trial is conducted

Germany, 

References & Publications (6)

Bösel J, Hacke W, Bendszus M, Rohde S. Treatment of acute ischemic stroke with clot retrieval devices. Curr Treat Options Cardiovasc Med. 2012 Jun;14(3):260-72. doi: 10.1007/s11936-012-0172-y. — View Citation

Davis MJ, Menon BK, Baghirzada LB, Campos-Herrera CR, Goyal M, Hill MD, Archer DP; Calgary Stroke Program. Anesthetic management and outcome in patients during endovascular therapy for acute stroke. Anesthesiology. 2012 Feb;116(2):396-405. doi: 10.1097/ALN.0b013e318242a5d2. — View Citation

Lees KR, Bluhmki E, von Kummer R, Brott TG, Toni D, Grotta JC, Albers GW, Kaste M, Marler JR, Hamilton SA, Tilley BC, Davis SM, Donnan GA, Hacke W; ECASS, ATLANTIS, NINDS and EPITHET rt-PA Study Group, Allen K, Mau J, Meier D, del Zoppo G, De Silva DA, Butcher KS, Parsons MW, Barber PA, Levi C, Bladin C, Byrnes G. Time to treatment with intravenous alteplase and outcome in stroke: an updated pooled analysis of ECASS, ATLANTIS, NINDS, and EPITHET trials. Lancet. 2010 May 15;375(9727):1695-703. doi: 10.1016/S0140-6736(10)60491-6. — View Citation

McDonagh DL, Olson DM, Kalia JS, Gupta R, Abou-Chebl A, Zaidat OO. Anesthesia and Sedation Practices Among Neurointerventionalists during Acute Ischemic Stroke Endovascular Therapy. Front Neurol. 2010 Nov 11;1:118. doi: 10.3389/fneur.2010.00118. eCollection 2010. — View Citation

Nogueira RG, Liebeskind DS, Sung G, Duckwiler G, Smith WS; MERCI; Multi MERCI Writing Committee. Predictors of good clinical outcomes, mortality, and successful revascularization in patients with acute ischemic stroke undergoing thrombectomy: pooled analysis of the Mechanical Embolus Removal in Cerebral Ischemia (MERCI) and Multi MERCI Trials. Stroke. 2009 Dec;40(12):3777-83. doi: 10.1161/STROKEAHA.109.561431. Epub 2009 Oct 29. — View Citation

Rha JH, Saver JL. The impact of recanalization on ischemic stroke outcome: a meta-analysis. Stroke. 2007 Mar;38(3):967-73. Epub 2007 Feb 1. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Duration of hospital stay		Participants will be followed until timepoint of discharge, an expected average of 3 weeks.	No
Other	Periinterventional complications		Evaluation of Adverse Events as a Measure of Safety and Tolerability until timepoint of discharge, an expected average of 3 weeks.	No
Other	Achieved recanalisation grade	Recanalisation status is classified according to the Thrombolysis in Cerebral Infarction classification (TICI).	Duration of intervention with an expected average of 2 hours	No
Primary	National Institutes of Health Stroke Scale (NIHSS) after 24 hours	Neurological improvement of NIHSS 24 hours after intervention	24 hours	No
Secondary	Outcome after 3 month using the modified Rankin Scale (mRS)	Assessing the neurological outcome after 3 months with the mRS.	3 month	No
Secondary	Inpatient-mortality		Mortality-rate until timepoint of discharge, an expected average of 3 weeks.	No
Secondary	Mortality-rate within the first 3 months after intervention.		First 3 months after intervention	No