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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
90
Sevorane Remifentanil
Remifentanil
Sahlgrenska University Hospital
Gothenburg, Sweden
Neurological outcome in the two different arms
Neurological outcome is measured as modified Rankin Scale (mRS), 90d post stroke.
Time frame: 90 days
NIHSS(National Institutes of Health Stroke Scale)
Change in NIHSS score on day 3, day 7 and 3 months compared to admission to hospital
Time frame: Day 3,7,90
The degree of recanalization and reperfusion
Measures as modified TICI(Thrombolysis In Cerebral Infarction)score
Time frame: 1 day (After completed embolectomy)
Periprocedural complications
Time frame: Perioperatively
Infarction magnitude
CT (computer tomography scan) Day 1 incl CTperfusion MR (magnetic resonance imaging) on day 3 (2-4) and 3 months Brain damage markers (GFAP, Tau, S-100B) before, 2, 24, 48, 72 hours and 3 months after the procedure.
Time frame: Day 1 to Day 90
Quantitative EEG changes
Quantitative EEG (electro encephalography) days 1, 2, and three months after onset
Time frame: Day 1,2,90
Time consumption
Time consumed from: stroke onset to CT angiography, CT angiography to start of anesthesia / sedation, stroke onset to start of embolectomy and duration of embolectomy.
Time frame: Periprocedural
Hospital length of stay
Hospital length of stay
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Time frame: Approximately 7-14 days