Skip to main content
OpenTrials
Completed

NCT Number: NCT02126085

Sedation vs. Intubation for Endovascular Stroke TreAtment

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Neurology, University Hospital Heidelberg

Heidelberg, Baden-Wurttemberg, 69120, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Endovascular recanalisation

Procedure

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

Primary outcomes

  1. National Institutes of Health Stroke Scale (NIHSS) after 24 hours

    Time frame: 24 hours

    Neurological improvement of NIHSS 24 hours after intervention

Secondary outcomes

  1. Outcome after 3 month using the modified Rankin Scale (mRS)

    Time frame: 3 month

    Assessing the neurological outcome after 3 months with the mRS.

  2. Inpatient-mortality

    Time frame: Mortality-rate until timepoint of discharge, an expected average of 3 weeks.

  3. Mortality-rate within the first 3 months after intervention.

    Time frame: First 3 months after intervention

Other outcomes

  1. Duration of hospital stay

    Time frame: Participants will be followed until timepoint of discharge, an expected average of 3 weeks.

  2. 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.

  3. 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).

Sponsors and collaborators

Lead sponsor

University Hospital Heidelberg

Other

Registry information

Acronym: SIESTA

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Apr 29, 2014
Registry last updated
May 24, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.