Sedation Versus General Anesthesia for Endovascular Therapy in Acute Stroke - Impact on Neurological Outcome (ANSTROKE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01872884|
Recruitment Status : Completed
First Posted : June 7, 2013
Last Update Posted : October 11, 2017
|Condition or disease||Intervention/treatment||Phase|
|Ischemic Stroke||Drug: Sevorane Remifentanil Drug: Remifentanil||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Sedation Versus General Anesthesia for Endovascular Therapy in Acute Stroke - Impact on Neurological Outcome|
|Actual Study Start Date :||November 14, 2013|
|Actual Primary Completion Date :||September 30, 2016|
|Actual Study Completion Date :||September 30, 2016|
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
- 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: Approximately 7-14 days ]Hospital length of stay
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|