Sedation Versus General Anesthesia for Endovascular Therapy in Acute Stroke - Impact on Neurological Outcome (ANSTROKE)
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||Sedation Versus General Anesthesia for Endovascular Therapy in Acute Stroke - Impact on Neurological Outcome|
- Neurological outcome in the two different arms [ Time Frame: 90 days ]Neurological outcome is measured as modified Rankin Scale (mRS), 90d post stroke.
- NIHSS(National Institutes of Health Stroke Scale) [ Time Frame: Day 3,7,90 ]Change in NIHSS score on day 3, day 7 and 3 months compared to admission to hospital
- The degree of recanalization and reperfusion [ Time Frame: 1 day (After completed embolectomy) ]Measures as modified TICI(Thrombolysis In Cerebral Infarction)score
- Periprocedural complications [ Time Frame: Perioperatively ]
- Infarction magnitude [ 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.
- Quantitative EEG changes [ Time Frame: Day 1,2,90 ]Quantitative EEG (electro encephalography) days 1, 2, and three months after onset
- Time consumption [ 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.
- Hospital length of stay [ Time Frame: Approximatly 7-14 days ]Hospital length of stay
|Study Start Date:||June 2013|
|Estimated Study Completion Date:||October 2016|
|Estimated Primary Completion Date:||October 2016 (Final data collection date for primary outcome measure)|
Experimental: General anaesthesia
General anaesthesia with mechanical ventilation. Sevorane Remifentanil. Bloodpressure control, systolic pressure 140-180 mmHg.
Drug: Sevorane Remifentanil
Other Name: tracheal intubation
Placebo Comparator: Sedation
Sedation with spontaneous breathing. Remifentanil. Bloodpressure control, systolic pressure 140-180 mmHg
Other Name: Conscious sedation
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01872884
|Sahlgrenska University Hospital|
|Gothenburg, Sweden, S-413 45 Göteborg|
|Principal Investigator:||Alexandros Rentzos, MD||Diagnostic and interventional Neuroradiology, Radiology department, Sahlgrenska Academy, University of Gothenburg|
|Principal Investigator:||Pia Löwhagen Henden, MD||Anesthesiology, Sahlgrenska Academy, University of Gothenburg|
|Study Director:||Sven-Erik Ricksten, MD PhD Prof||Sahlgrenska Academy, University of Gothenburg|