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The hypothesis of this study is that sedoanalgesia will provide better early neurological recovery than general anaesthesia in acute ischaemic stroke patients undergoing endovascular thrombectomy and to investigate the haemodynamic data of both anaesthetic methods.
Endovascular mechanical thrombectomy (EMT) is the standard emergency treatment for patients presenting with acute ischemic stroke in the anterior circulation due to urgent large vessel occlusion and suitable for interventional procedures. However, despite reperfusion of the ischemia-affected area, some patients do not recover clinically. The reason for this is not known exactly. It is known that age and baseline function, which are thought to indicate brain reserve, affect the long-term outcome of stroke. Chronic hypertension, diabetes mellitus, dyslipidemia and coronary artery disease, which are associated with low brain reserve, are quite common in acute ischemic stroke patients.
There is controversy as to whether general anesthesia (GA) or sedoanalgesia (SA) should be used during EMT for acute ischemic stroke. There are not enough randomized trials addressing this question. Benefits of GA include airway preservation, pain control and potentially improved radiographic imaging and patient immobility for intervention. Conversely, GA is time-consuming and possibly associated with longer time for groin puncture and revascularization. In addition, hypotension may occur during GA, which carries a greater risk of ischemic damage. Advantages of SA may include shorter time to revascularization, fewer hemodynamic problems and the possibility of better neurological assessment during the procedure. The main arguments against SA are that patient movement can lead to procedural complications, higher radiation dose, the need for more contrast media and lack of airway control. Simonsen et al. compared general anesthesia and conscious sedation in patients with acute ischemic stroke undergoing endovascular treatment (GOLIATH) and showed that the choice of different anesthesia method can affect infarct area growth, clinical outcomes, and important physiological and anesthetic parameters.
Again, in the SIESTA (Sedation vs Intubation for Endovascular Stroke Treatment) study comparing sedation and intubation in endovascular stroke treatment, no significant difference was shown between both groups when early neurological recovery was compared (24th hour NIHSS). In this study, no superiority of conscious sedation over general anesthesia was demonstrated.
In the ESCAPE and SWIFT study, general anesthesia and conscious sedation were compared and conscious sedation was associated with better outcome than general anesthesia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sedoanalgesia (SA) group | Active Comparator | The aim was to achieve a moderate level of sedoanalgesia (previously called conscious sedation) that would reduce agitation, anxiety and mobility but allow communication with the patient. Sedation was maintained at a level where cardiovascular function was preserved and no intervention was required to protect the airway in spontaneous breathing. Fentanyl iv 25-50 µg bolus was administered to each patient undergoing sedoanalgesia. For maintenance of sedoanalgesia, propofol iv infusion was started at doses of 1-2 mg kg-1 hour. It was titrated according to BIS level. In case of patient noncompliance, propofol iv 0.5 mg kg-1 was intervened. |
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| General anesthesia (GA) group | Active Comparator | Anesthesia induction was performed with lidocaine iv 0.5 mg kg-1, propofol iv 1-2 mg kg-1, fentanyl iv 25-50 µg. After providing adequate ventilation with a mask, rocuronium iv 0.45-0.6 mg kg-1 is administered and endotracheal intubation is performed. After intubation is confirmed with end-tidal CO2 monitoring, tidal volume is set to 6-8 ml kg-1 and respiratory frequency to 12/min in CMV mode. In order to maintain cerebral perfusion, PaCO2: 35-40 mmHg is aimed to be maintained. Sevoflurane MAC 0.8 and remifentanil infusion 0.03 µg kg-1 min iv were used for maintenance of anesthesia. At the end of the procedure, sugammadex iv 2mg kg-1 was administered for extubation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sedoanalgesia | Procedure | In Acute Ischemic Stroke Patients Undergoing Endovascular Thrombectomy, the procedure was performed under sedoanalgesia. The procedure was continued with mean arterial pressure, heart rate, pulse oximetry and BIS monitoring. |
| Measure | Description | Time Frame |
|---|---|---|
| scoring systems of neurological findings | NIHSS (National Institutes of Health Stroke Scale), Glasgow coma scale (GCS) and FOUR (Full Outline of UnResponsiveness) scores | Before Endovascular Thrombectomy and after 48 hours |
| effects of both anesthesia management on hemodynamics during the procedure | Mean arterial pressure, heart rate | Before the Endovascular Thrombectomy procedure and until the end of the recovery period (4 hours) |
| Measure | Description | Time Frame |
|---|---|---|
| early neurological outcome findings | hemiparesis, hemiplegia, aphasia, facial paralysis | 48 hours |
| mortality and morbidity | exitus,discharge to home or palliative unit |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Umraniye Education and Research Hospital | Istanbul | Umraniye | 34734 | Turkey (Türkiye) |
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Patients were divided into two groups as sedoanalgesia group (SA=31 patients) and general anesthesia group (GA=31 patients).
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The study was double-blinded, patients were selected by closed envelope method, and different clinicians administered anesthesia and postoperative follow-up.
| general anesthesia | Procedure | In Acute Ischemic Stroke Patients Undergoing Endovascular Thrombectomy, the procedure was performed under general anesthesia. The procedure was continued with mean arterial pressure, heart rate, pulse oximetry and BIS monitoring. |
|
| hospitalization days |
| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| D009461 | Neurologic Manifestations |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000768 | Anesthesia, General |
| ID | Term |
|---|---|
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
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