Table 1. Characteristics of Studies Included in a Meta-analysis Examining the Association of General Anesthesia vs Procedural Sedation With Functional Outcome Among Patients With Acute Ischemic Stroke Undergoing Thrombectomy.
| Trial Characteristics | SIESTA10 | ANSTROKE11 | GOLIATH12 |
|---|---|---|---|
| Inclusion criteria | Age ≥18 y | Age ≥18 y | Age ≥18 y |
| NIHSS score ≥10 | NIHSS score ≥10 | NIHSS score ≥10 | |
| Acute ischemic stroke in anterior circulation | Acute ischemic stroke in anterior circulation | Acute ischemic stroke in anterior circulation | |
| Waiver of consent before randomization and deferred informed consent by the patient or a legal representative after mechanical thrombectomy | Oral consent prior to randomization from patient or relative and written consent after treatment from patient or relative | Waiver of consent prior randomization and deferred informed consent by the patient or a legal representative after mechanical thrombectomy | |
| Exclusion criteria and reasons for exclusion | Radiologic ambiguity concerning infarction and vessel occlusion (n = 1561) Additional clinical and radiologic signs of occlusion of a vessel other than those listed under inclusion criteria Additional intracerebral hemorrhage Severe agitation on admission (n = 42) 2 Simultaneous thrombectomies and 1 not managed by neurointensivists (n = 35) Obvious loss of airway protective reflexes and/or vomiting on admission (n = 7) Obviously difficult or known difficult airway Known intolerance of certain medication for sedation and/or analgesia Other (n = 11) |
Radiologic ambiguity concerning infarction and vessel occlusion (n = 17) Additional clinical and radiologic signs of an occlusion of a vessel other than those listed under inclusion criteria (n = 29) Additional intracerebral hemorrhage Not eligible because of anesthesiological concerns (n = 59) Could not receive mechanical thrombectomy within 8 h from symptoms first observed NIHSS score <14 in left-sided stroke Premorbid mRS score of ≥4 Informed consent not timely obtained or died (n = 39) Inclusion failure (n = 11) Other (n = 60) |
Radiologic ambiguity concerning infarction and vessel occlusion (n = 1105) Additional clinical and radiologic signs of occlusion of a vessel other than those listed under inclusion criteria (n = 107) Additional intracerebral hemorrhage Known intolerance of certain medication for sedation and/or analgesia Could not receive mechanical thrombectomy within 6 h from symptoms first observed (n = 35) Premorbid mRS score >2 Initial infarct volume on MRI of >70 mL (n = 62) Contraindications to MRI (n = 18) Intubated at arrival (n = 7) Included in other studies (n = 3) Other (n = 36) |
| No. of patients approached | 1808 | 321 | 1501 |
| No. of patients randomized | 152 | 106 | 128 |
| No. of patients analyzed | 150 | 90 | 128 |
| Primary end point | Change in NIHSS score after 24 h | mRS after 3 mo | Infarct growth measured via MRI |
| Reasons for conversion from procedural sedation to general anesthesia | Agitation and/or movement Aspiration Respiratory failure Vomiting Other |
Agitation and/or movement Aspiration Puncture of common carotid artery |
Agitation Aspiration Respiratory failure Vomiting |
Abbreviations: ANSTROKE, Anesthesia During Stroke; GOLIATH, General or Local Anesthesia in Intra Arterial Therapy; MRI, magnetic resonance imaging; mRS, modified Rankin Scale; NIHSS, National Institutes of Health Stroke Scale; SIESTA, Sedation vs Intubation for Endovascular Stroke Treatment.