Trial document




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  DRKS00006801

Trial Description

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Title

Impact of Anesthesia during endovascular treatment of acute ischemic stroke

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Trial Acronym

STENOsIS

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URL of the Trial

[---]*

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Brief Summary in Lay Language

In this study we will analyse the effect of anesthesia (general anesthesia or sedation) during endovascular therapy in acute ischemic stroke

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Brief Summary in Scientific Language

Endovascular clot retrieval in acute ischemic stroke can be performed under monitored anesthesia care (MAC) or general anesthesia (GA). In this trial we will investigate the impact of anesthesia (CS vs GA) on the neurologic outcome of the patients.

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Organizational Data

  •   DRKS00006801
  •   2014/10/13
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  •   yes
  •   Approved
  •   2014-344-f-S, Ethik-Kommission der Ärztekammer Westfalen-Lippe und der med. Fakultät der Westfälischen Wilhelms-Universität Münster
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Secondary IDs

  •   05-AnIt-14 
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Health Condition or Problem studied

  •   I64 -  Stroke, not specified as haemorrhage or infarction
  •   I63 -  Cerebral infarction
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Interventions/Observational Groups

  •   control group: general anesthesia
  •   Intervention group: sedation
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Prognosis
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

neurologic outcome (modified Rankin Score mRS) 3 months after stroke

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Secondary Outcome

- neurological outcome at discharge
- mortality (in hospital, after 3 months)
- length of ICU stay
- door to first pass
- rate of recanalization

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2014/12/09
  •   130
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   85   Years
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Additional Inclusion Criteria

- acute ischemic stroke with the indication for endovascular clot retrieval
-anterior circulation stroke
- acute focal neurological deficit
- spontaneous breathing

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Exclusion Criteria

- intracerebral tumor
- intracerebral hemorrhage
- severe stroke (NIHSS > 25)
- seizure at beginning of treatment
- significant trauma within the last 3 month
- intracranial surgery in medical history
- blood glucose < 50 mg/dl or > 400 mg/dl
- alcohol abuse
- chronic pain
- severe systemic infections
- dementia (mRS>=3)

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Addresses

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    • Universitätsklinikum MünsterKlinik für Anästhesiologie, operative Intensivmedizin und Schmerztherapie
    • Albert-Schweitzer-Campus 1, A1
    • 48149  Münster
    • Germany
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    • Universitätsklinikum MünsterKlinik für Anästhesiologie, operative Intensivmedizin und Schmerztherapie
    • Ms.  Dr.  Kathrin  Waurick 
    • Albert-Schweitzer-Campus 1, A1
    • 48149  Münster
    • Germany
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    • Universitätsklinikum MünsterKlinik für Anästhesiologie, operative Intensivmedizin und Schmerztherapie
    • Ms.  Dr.  Kathrin  Waurick 
    • Albert-Schweitzer-Campus 1, A1
    • 48149  Münster
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum MünsterKlinik für Anästhesiologie, operative Intensivmedizin und Schmerztherapie
    • 48149  Münster
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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