Sedation Versus General Anesthesia for Endovascular Therapy in Acute Stroke - Impact on Neurological Outcome "ANSTROKE"

Completed

Phase N/A Results N/A

Trial Description

The purpose of this study is to evaluate whether general anesthesia or sedation technique is preferable during embolectomy for stroke, measured in terms of three months neurological impairment. In addition we study if there is any difference between the methods regarding complication frequency.

Detailed Description

Stroke is a common cause of neurological disability. Early diagnosis of ischemic stroke now enables treatment with thrombolysis and / or endovascular therapy (embolectomy). In order to implement this procedure, the duration of which varies from 2-6 hours, the patient has to remain immobilized. Two techniques are currently used routinely to achieve this.
One technique is general anaesthesia, that will ensure that the patient is completely immobile throughout the procedure, which is an advantage from a neuroimaging perspective. A disadvantage is that preparation for, and the induction of anesthesia prolongs the time to embolectomy. Another disadvantage may be that the patient´s blood pressure drops during anesthesia, which could impair the brain blood supply and subsequently neurological outcome. The ability to evaluate the patient's neurological symptoms also disappears.
The second technique consists of sedation during surgery. The advantages of this technique are that the time to the beginning of embolectomy is getting shorter and the blood pressure becomes more stable. One drawback is that it cannot guarantee that the patient remains immobile throughout the procedure, which increases the risk of motion artifacts and may lead to the duration of embolectomy becomes prolonged. There is also a risk of hypoventilation and the patient aspirates during surgery.
Retrospective studies suggest that patients receiving general anesthesia have worse neurologic outcome three months after stroke. This could be explained by more or less pronounced anesthesia-induced episodes of hypotension, compared with lightly sedated patients with more stable blood pressure. In these retrospective analyzes, however, the patients who received general anesthesia were, neurologically speaking, more ill than patients who only received sedation. This may probably, at least in part, explain why anesthetized patients have a worse neurologic outcome. In these retrospective studies, many centers were involved, with various endovascular and anesthesia procedures.

Conditions

Interventions

  • Sevorane Remifentanil Drug
    Other Names: tracheal intubation
    Intervention Desc: Sevorane Remifentanil
    ARM 1: Kind: Experimental
    Label: General anaesthesia
    Description: General anaesthesia with mechanical ventilation. Bloodpressure control, systolic pressure 140-180 mmHg.
  • Remifentanil Drug
    Other Names: Conscious sedation
    Intervention Desc: Remifentanil
    ARM 1: Kind: Experimental
    Label: Sedation
    Description: Sedation with spontaneous breathing. Bloodpressure control, systolic pressure 140-180 mmHg

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Prevention
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Neurological outcome in the two different arms 90 days Yes
Secondary NIHSS(National Institutes of Health Stroke Scale) Day 3,7,90 Yes
Secondary The degree of recanalization and reperfusion 1 day (After completed embolectomy) Yes
Secondary Periprocedural complications Perioperatively Yes
Secondary Infarction magnitude Day 1 to Day 90 Yes
Secondary Quantitative EEG changes Day 1,2,90 Yes
Secondary Time consumption Periprocedural Yes
Secondary Hospital length of stay Approximatly 7-14 days Yes

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