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| ID | Type | Description | Link |
|---|---|---|---|
| ALFGBG-75870 | Other Grant/Funding Number | Swedish State Support for Clinical Research (ALFGBG-75870) |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| General anaesthesia | Experimental | General anaesthesia with mechanical ventilation. Sevorane Remifentanil. Bloodpressure control, systolic pressure 140-180 mmHg. |
|
| Sedation | Placebo Comparator | Sedation with spontaneous breathing. Remifentanil. Bloodpressure control, systolic pressure 140-180 mmHg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sevorane Remifentanil | Drug | Sevorane Remifentanil |
|
| Measure | Description | Time Frame |
|---|---|---|
| Neurological outcome in the two different arms | Neurological outcome is measured as modified Rankin Scale (mRS), 90d post stroke. | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| NIHSS(National Institutes of Health Stroke Scale) | Change in NIHSS score on day 3, day 7 and 3 months compared to admission to hospital | Day 3,7,90 |
| The degree of recanalization and reperfusion |
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Inclusion Criteria:Patients with acute stroke considered for thrombectomy and meeting the following inclusion criteria included:
the patient is ≥ 18 years
the patient has a CT angio verified embolization * and / or a NIHSS scores ** ≥ 10 (R) or 14 (L) depending on the side engagement
embolectomy (= groin puncture) started <8 hours after symptom onset
Embolus in one of the following arteries: internal carotid artery, anterior cerebral (A1 segment), cerebri media (M1 segment) and proximal cerebri media branches (M2 segment).
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Sven-Erik Ricksten, MD PhD Prof | Sahlgrenska Academy, University of Gothenburg | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sahlgrenska University Hospital | Gothenburg | S-413 45 Göteborg | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20431082 | Background | Jumaa MA, Zhang F, Ruiz-Ares G, Gelzinis T, Malik AM, Aleu A, Oakley JI, Jankowitz B, Lin R, Reddy V, Zaidi SF, Hammer MD, Wechsler LR, Horowitz M, Jovin TG. Comparison of safety and clinical and radiographic outcomes in endovascular acute stroke therapy for proximal middle cerebral artery occlusion with intubation and general anesthesia versus the nonintubated state. Stroke. 2010 Jun;41(6):1180-4. doi: 10.1161/STROKEAHA.109.574194. Epub 2010 Apr 29. | |
| 20431708 |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D007442 | Intubation, Intratracheal |
| D000077208 | Remifentanil |
| D016292 | Conscious Sedation |
| ID | Term |
|---|---|
| D058109 | Airway Management |
| D013812 | Therapeutics |
| D007440 | Intubation |
| D008919 | Investigative Techniques |
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| Remifentanil | Drug | Remifentanil |
|
|
Measures as modified TICI(Thrombolysis In Cerebral Infarction)score
| 1 day (After completed embolectomy) |
| Periprocedural complications | 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. | Day 1 to Day 90 |
| Quantitative EEG changes | Quantitative EEG (electro encephalography) days 1, 2, and three months after onset | 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. | Periprocedural |
| Hospital length of stay | Hospital length of stay | Approximately 7-14 days |
| Background |
| Nichols C, Carrozzella J, Yeatts S, Tomsick T, Broderick J, Khatri P. Is periprocedural sedation during acute stroke therapy associated with poorer functional outcomes? J Neurointerv Surg. 2010 Mar;2(1):67-70. doi: 10.1136/jnis.2009.001768. Epub 2009 Dec 17. |
| 20395617 | Background | Abou-Chebl A, Lin R, Hussain MS, Jovin TG, Levy EI, Liebeskind DS, Yoo AJ, Hsu DP, Rymer MM, Tayal AH, Zaidat OO, Natarajan SK, Nogueira RG, Nanda A, Tian M, Hao Q, Kalia JS, Nguyen TN, Chen M, Gupta R. Conscious sedation versus general anesthesia during endovascular therapy for acute anterior circulation stroke: preliminary results from a retrospective, multicenter study. Stroke. 2010 Jun;41(6):1175-9. doi: 10.1161/STROKEAHA.109.574129. Epub 2010 Apr 15. |
| 22222475 | Background | Davis MJ, Menon BK, Baghirzada LB, Campos-Herrera CR, Goyal M, Hill MD, Archer DP; Calgary Stroke Program. Anesthetic management and outcome in patients during endovascular therapy for acute stroke. Anesthesiology. 2012 Feb;116(2):396-405. doi: 10.1097/ALN.0b013e318242a5d2. |
| 35857365 | Derived | Tosello R, Riera R, Tosello G, Clezar CN, Amorim JE, Vasconcelos V, Joao BB, Flumignan RL. Type of anaesthesia for acute ischaemic stroke endovascular treatment. Cochrane Database Syst Rev. 2022 Jul 20;7(7):CD013690. doi: 10.1002/14651858.CD013690.pub2. |
| 28522637 | Derived | Lowhagen Henden P, Rentzos A, Karlsson JE, Rosengren L, Leiram B, Sundeman H, Dunker D, Schnabel K, Wikholm G, Hellstrom M, Ricksten SE. General Anesthesia Versus Conscious Sedation for Endovascular Treatment of Acute Ischemic Stroke: The AnStroke Trial (Anesthesia During Stroke). Stroke. 2017 Jun;48(6):1601-1607. doi: 10.1161/STROKEAHA.117.016554. |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D011422 |
| Propionates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000760 | Anesthesia and Analgesia |