Sahlgrenska University Hospital
Gothenburg, S-413 45 Göteborg, Sweden
NCT Number: NCT01872884
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Gothenburg, S-413 45 Göteborg, Sweden
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Patients with acute stroke considered for thrombectomy and meeting the following inclusion criteria included:
Exclusion criteria
Sevorane Remifentanil
Other names: tracheal intubation
Remifentanil
Other names: Conscious sedation
Time frame: 90 days
Neurological outcome is measured as modified Rankin Scale (mRS), 90d post stroke.
Time frame: Day 3,7,90
Change in NIHSS score on day 3, day 7 and 3 months compared to admission to hospital
Time frame: 1 day (After completed embolectomy)
Measures as modified TICI(Thrombolysis In Cerebral Infarction)score
Time frame: Perioperatively
Time frame: Day 1 to Day 90
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 1,2,90
Quantitative EEG (electro encephalography) days 1, 2, and three months after onset
Time frame: Periprocedural
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: Approximately 7-14 days
Hospital length of stay
Sahlgrenska University Hospital
Other
Acronym: ANSTROKE
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