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

Sponsor:

Information provided by (Responsible Party):

Dr. Silvia Schönenberger, MD, University Hospital Heidelberg

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Acute Ischemic Stroke	Procedure: Endovascular recanalisation	Not Applicable

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.

Study Design

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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

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Intubation Intubation and invasive mechanical ventilation + endovascular recanalisation	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	Procedure: Endovascular recanalisation Endovascular recanalisation by mechanical thrombectomy with e.g. stent retriever device, possibly following intravenous thrombolysis within a "bridging concept"

Outcome Measures

Primary Outcome Measures :

National Institutes of Health Stroke Scale (NIHSS) after 24 hours [ Time Frame: 24 hours ]
Neurological improvement of NIHSS 24 hours after intervention

Secondary Outcome Measures :

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 ]

Other Outcome Measures:

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).

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Information from the National Library of Medicine

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

Locations

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Germany
Department of Neurology, University Hospital Heidelberg
Heidelberg, Baden-Württemberg, Germany, 69120

Sponsors and Collaborators

University Hospital Heidelberg

Investigators

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Principal Investigator:	Julian Bösel, PD	Department of Neurology, University Hospital Heidelberg

More Information

Publications:

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.

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.

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.

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.

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.

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Schönenberger S, Uhlmann L, Ungerer M, Pfaff J, Nagel S, Klose C, Bendszus M, Wick W, Ringleb PA, Kieser M, Möhlenbruch MA, Bösel J. Association of Blood Pressure With Short- and Long-Term Functional Outcome After Stroke Thrombectomy: Post Hoc Analysis of the SIESTA Trial. Stroke. 2018 Jun;49(6):1451-1456. doi: 10.1161/STROKEAHA.117.019709. Epub 2018 May 2.

Schönenberger S, Uhlmann L, Hacke W, Schieber S, Mundiyanapurath S, Purrucker JC, Nagel S, Klose C, Pfaff J, Bendszus M, Ringleb PA, Kieser M, Möhlenbruch MA, Bösel J. Effect of Conscious Sedation vs General Anesthesia on Early Neurological Improvement Among Patients With Ischemic Stroke Undergoing Endovascular Thrombectomy: A Randomized Clinical Trial. JAMA. 2016 Nov 15;316(19):1986-1996. doi: 10.1001/jama.2016.16623. Erratum in: JAMA. 2017 Feb 7;317(5):538.

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Responsible Party:	Dr. Silvia Schönenberger, MD, Leading sub-investigator, Principal Investigator: PD Dr. Julian Bösel, MD, University Hospital Heidelberg
ClinicalTrials.gov Identifier:	NCT02126085 History of Changes
Other Study ID Numbers:	SIESTA
First Posted:	April 29, 2014 Key Record Dates
Last Update Posted:	May 24, 2016
Last Verified:	May 2016

Keywords provided by Dr. Silvia Schönenberger, MD, University Hospital Heidelberg:


ischemic stroke recanalisation sedation

Additional relevant MeSH terms:

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Stroke Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases	Nervous System Diseases Vascular Diseases Cardiovascular Diseases

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