Please select the eligibility criteria that correspond to the clinical trial below.
Title: SEGA - SEdation Versus General Anesthesia for Endovascular Therapy in Acute Ischemic Stroke - a Randomized Comparative Effectiveness Trial.
Brief Summary: Objectives:

This study aims to estimate overall treatment benefit (improvement in disability) among acute ischemic stroke patients that are randomized to General Anesthesia (GA) compared with Sedation (CS) during endovascular therapy. Assess safety (as measured by incidence of symptomatic intracranial hemorrhage); rates of Endovascular therapy (EVT) procedural complications, reperfusion; and quality of life.

Hypothesis:

GA during EVT for acute ischemic stroke improves functional outcomes at 90 days compared to sedation.


Options:
A: Inclusion Criteria:

* Patients with acute ischemic stroke in posterior cerebral circulation scheduled to receive emergency endovascular treatment; Age \> 18; The onset time is within 24 hours; Modified rankin score ≤2 before onset.

Exclusion Criteria:

* Radiological ambiguity concerning infarction and vessel occlusion; Additional intracerebral hemorrhage; Anterior circulation infraction; Coma on admission (Glasgow coma score less than 8); NIHSS less than 6 or more than 30; Severe agitation or seizures on admission; Obvious loss of airway protective reflexes and/or vomiting on admission; Being intubated before treatment on admission; Known allergy to anesthetic or analgesic;
B: Inclusion Criteria:

1. Acute ischemic stroke due to large intracranial vessel occlusion demonstrated on CT-angiography in the following anterior circulation locations that will be treated by endovascular therapy (EVT):

   1. Internal Carotid Artery (terminal "T" or "L-type"- occlusion)
   2. Middle Cerebral Artery (MCA) M1 or proximal M2
   3. Anterior Cerebral Artery (ACA) A1 or proximal A2

      * Patients who receive IV-tPA thrombolysis are eligible provided the drug was delivered within 4.5 hours of stroke onset or last seen normal and in accordance with local hospital standard of care.
2. Ages 18-90.
3. National Institute of Health Stroke Scale (NIHSS) score 6-30
4. Time of from stroke symptom onset of last seen normal to start of EVT (defined as groin puncture) ≤ 16 hours.
5. Limited infarct core, as defined below and adapted from the 2018 American Heart Association guidelines

   1. For patients presenting ≤ 6 hours from time of symptom onset or last seen normal, Alberta Stroke Program Early Computed Tomography Score (ASPECTS) ≥ 6
   2. For patients presenting \> 6 hours and ≤ 16 hours from time of symptom onset or last seen normal, they must satisfy EITHER ONE of the two following criteria:

   i. Ischemic core by CT Perfusion or MRI/MR Perfusion \< 70 mL, a ratio of volume of penumbral tissue to infarct core of ≥ 1.8, and and absolute volume of penumbral tissue of ≥ 15 mL OR ii. For patients with NIHSS ≥ 10, infarct core of \< 31 mL by CT Perfusion or MRI; For patients with NIHSS ≥ 20, infarct core \< 51 mL.
6. Subject willing/able to return for protocol required follow up visits.
7. No significant pre-stroke disability (modified Rankin Score must be ≤ 2).
8. Females of childbearing potential must have a negative serum or urine pregnancy test.
9. Patient or patient's legally authorized representative has given Informed Consent according to Good Clinical Practices (GCP) and/or local IRB policies.

Exclusion Criteria:

1. Coma on admission (Glasgow Coma Scale \<8), need for intubation upon ED arrival, or transferred patients who present previously intubated.
2. Severe agitation or seizures on admission that preclude safe vascular access.
3. Loss of airway protective reflexes and/or vomiting on admission.
4. Predicted or known difficult airway.
5. Pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluations, e.g. dementia.
6. Presumed septic embolus, or suspicion of bacterial endocarditis
7. Currently participating or has participated in any investigational drug or device study within 30 days.
8. Inability to follow-up for 90-day assessment.
9. Known history of allergy to anesthesia drugs.
10. Known history or family history of malignant hyperthermia
C: Inclusion Criteria:

1. Age ≥18
2. NIHSS ≥ 6 within 0-16h or NIHSS ≥ 10 within 16-24h
3. Anterior circulation large vessel occlusion (ICA, M1, M2)
4. ASPECTS score ≥ 6 within the first 6h, or DEFUSE trial imaging criteria within 6-16h; or DAWN trial clinical/imaging mismatch criteria within 16-24h
5. Premorbid modified Rankin Scale (mRS) 0-2
6. Patient deemed candidate for mechanical thrombectomy with anticipated groin puncture within 24 hours of last known well and within 90 min of ED arrival

Clinical Exclusion Criteria:

1. Intubation in ED prior to anesthesiologist evaluation, or intubation for any other medical reason other than planned thrombectomy
2. Rapid neurological improvement, suggestive of revascularization
3. Known serious sensitivity to radiographic contrast agents.
4. Current participation in another investigational drug or device treatment study.
5. Renal Failure as defined by a serum creatinine \> 2.0 mg/dl (or 176.8 μmol/l) or Glomerular Filtration Rate \[GFR\] \< 30.
6. Subject who requires hemodialysis or peritoneal dialysis, or who have a contraindication to an angiogram for whatever reason.
7. Life expectancy of less than 90 days.
8. Clinical presentation suggests a subarachnoid hemorrhage, even if initial CT or MRI scan is normal
9. Subject with a co-morbid disease or condition that would confound the neurological and functional evaluations or compromise survival or ability to complete follow up assessments.
10. Subject currently uses or has a recent history of illicit drug(s) or abuses alcohol (defined as regular or daily consumption of more than 4 alcoholic drinks per day.
11. Septic or cardiogenic shock with severe life-threatening hypotension

Imaging Exclusion Criteria:

1. Computed tomography (CT) or Magnetic Resonance Imaging (MRI) evidence of acute intracranial hemorrhage on presentation.
2. CT or MRI evidence of mass effect or intracranial tumor (except small meningioma).
3. CT showing hypodensity or MRI showing hyperintensity involving greater than 1/3 of the middle cerebral artery (MCA) territory (or in other territories, \>100 cc of tissue) on presentation.
4. Baseline non contrast CT or DWI MRI evidence of a moderate/large core defined as extensive early ischemic changes of Alberta Stroke Program Early CT score (ASPECTS) \< 6
5. CT or MRI evidence that ischemia is not in anterior circulation distribution.
6. Imaging evidence that suggests, in the opinion of the investigator, the subject is not appropriate for mechanical thrombectomy intervention (e.g., inability to navigate to target lesion, moderate/large infarct with poor collateral circulation, etc.).

Anesthesia exclusion criteria (relative):

1. History of Malignant Hyperthermia
2. History of allergic reaction/anaphylaxis to anesthetic drugs
3. Inability to tolerate supine position (severe CHF)
4. Chronic O2 dependence or any other known pulmonary condition that might lead to difficult extubation and prolonged mechanical ventilation including known pulmonary hypertension
D: Inclusion Criteria:

* NIHSS\>10
* mRS=\<2
* groin puncture\<6hours from stroke onset
* occlusion of ICA, ICA-T, M1, M2

Exclusion Criteria:

* MRI contraindications
* GCS\<9
* intubated prior to arrival
* posterior circulation stroke
* allergy to anestetics

Answer: B