Table 2.
Inclusion, exclusion criteria, study design and outcome assessments of the included studies.
| Trials | Schonenberger et al. (17) (NCT02126085) |
|---|---|
| Inclusion criteria | Patients with the following criteria were included: severe ischemic stroke defined by a National Institutes of Health Stroke Scale (NIHSS) score >10 [range, 0–42 with higher scores indicating more severe neurological deficits (a difference of 4 points was considered to be clinically relevant)], isolated or combined occlusion at any level of the internal carotid artery or the middle cerebral artery, decision for thrombectomy according to the internal protocol for acute recanalizing stroke treatment of the Heidelberg University Hospital and at the discretion of the physician in charge |
| Exclusion criteria | Patients were excluded from the trial if diagnostic imaging results did not clearly depict site of vessel occlusion; their clinical or imaging findings suggested occlusion of a cerebral vessel that was not an internal carotid artery or a middle cerebral artery, or imaging showed intracerebral hemorrhage; coma at admission [Glasgow Coma Scale (GCS) score < 8 (range, 3–15 points with 3 being the worst and 15 the best, composed of 3 parameters: best eye response, best verbal response, and best motor response)]; severe agitation at admission (making groin and vascular access impossible); loss of airway-protective reflexes of at least absence of gag reflex, insufficient saliva handling, observed aspiration, vomiting, or a combination thereof at admission; obviously or known difficult airway; or known intolerance of certain medications for sedation, analgesia, or both |
| Study design | This was a single-center, parallel-group, open-label RCT with blinded end point evaluation [PROBE (prospective, randomized, open, blinded end point) design]. In this trial, patients selected for thrombectomy were preliminarily randomized 1:1 (using sealed, opaque envelopes based on a computer-generated list not allowing for sequence guessing) to receive either conscious sedation or general anesthesia, standardized according to institutional treatment protocols |
| Efficacy outcomes | Change in NIHSS score 24 h after intervention; mRS scores at 3 months |
| Safety outcomes | Adverse events, serious adverse events and death |
| Trials | Lowhagen Henden et al. (24) (NCT01872884) |
| Inclusion criteria | (1) ≥18 years of age, (2) proven occlusion in anterior cerebral circulation by computed tomographic (CT) angiography and NIHSS score ≥10 (if right-sided occlusion) or ≥14 (if left-sided occlusion), and (3) treatment initiated within 8 h after onset of symptoms |
| Exclusion criteria | (1) The patient was not eligible for randomization because of anesthesiological concerns (airway, agitation, etc) at the discretion of the attending anesthetist, (2) occlusion of posterior cerebral circulation, (3) intracerebral hemorrhage, (4) neurological recovery or recanalization before or during angiography, and (5) premorbidity modified Rankin Scale (mRS) score ≥4 or other comorbidity contraindicating embolectomy |
| Study design | All admitted patients were directly transported to the CT laboratory where the neurological examination and the CT examination were performed simultaneously. Patients who were eligible for EVT were then transported directly to the neurointerventional suite. In the absence of contraindications, intravenous thrombolysis was started before EVT in all patients. After informed consent, patients were randomly allocated in blocks to either GA or CS in a 1:1 ratio using sealed non-transparent envelopes |
| Efficacy outcomes | Difference in mRS scores at 3 months; Composite of death, non-fatal stroke, TIA, or peripheral embolism. The NIHSS score shifts at 24 h, day 3, and hospital discharge, as well as cerebral infarction volume at day 3, ASPECTS at day 3 |
| Safety outcomes | Adverse events, serious adverse events and death |
| Trials | Simonsen et al. (25) (NCT02317237) |
| Inclusion criteria | We included all adult patients (18 years of age or older) who presented with large vessel occlusions in the anterior circulation and in whom groin puncture could be performed within 6 h from symptom on set or when last seen well |
| Exclusion criteria | We excluded patients who were intubated at presentation or with a Glasgow Coma Scale score (score range: 3–15, with a lower score indicating lower levels of consciousness) lower than 9 as well as those who were not living independently and had a premorbid mRS score (score range: 0–6, with a lower score indicating independent living) of more than 2. Because the primary trial end point was infarct growth, we required a diffusion weighted imaging (DWI) MRI scan to establish a baseline (preEVT) infarct volume. Therefore, patients with a contraindication to MRI were excluded. In addition to the DWI scan, the imaging protocol consisted of a T2*–a T2 fluid attenuated inversion recovery—and anangiography sequence. Imaging time was 11 min. Patients with baseline infarcts >70 mL were excluded, given their reduced likelihood for achieving good clinical outcomes. Movement or agitation was not a contraindication for the study |
| Study design | The GOLIATH trial was an investigator-initiated, single-center prospective, randomized, open-label, blinded end-point (or PROBE) evaluation that enrolled patients from March 12, 2015, to February 2, 2017. Patients were randomized to GA or CS in a 1:1 fashion |
| Efficacy outcomes | The primary outcome was infarct growth, measured in milliliters. Secondary outcome measures were mRS scores after 90 days, time and blood pressure levels |
| Safety outcomes | Adverse events, serious adverse events and death |
| Trials | Ren et al. (27) (ChiCTR-IPR-16008494) |
| Inclusion criteria | American Society of Anesthesiologists (ASA) grades I–III; National Institutes of Health Stroke Scale (NIHSS) score < 20; AIS within 6.5 h of symptom onset; age ≥60 years; and intracranial proximal arterial occlusion in the anterior circulation (carotid artery, M1 or M2 segments of the middle cerebral artery, or A1 segment of the anterior cerebral artery) demonstrated by computed tomography angiography, magnetic resonance angiography, or digital subtraction angiography (DSA) |
| Exclusion criteria | Prestroke modified Rankin Scale (mRS) score > 2; hemorrhage demonstrated by computed tomography (CT); obvious or known difficult airway; cognitive impairment; disturbance of consciousness; hypoxemia (SpO2 < 90%); occlusion in the posterior circulation; or body mass index (BMI) >30 kg/m2 |
| Study design | In this single-center study, a computer-generated randomization table was used by an independent anesthesia assistant to allocate patients into two groups: the CS group (n = 42) and the GA group (n = 48) |
| Efficacy outcomes | The primary outcome was a favorable neurologic outcome at 90 days [favorable outcome was defined as mRS score 0–2 and unfavorable as mRS score 3–6]. Secondary outcomes included baseline characteristics, intraprocedural hemodynamics (recorded at the following time points: arrival at catheterization laboratory [T0]; before puncture [T1]; after angiography [T2]; 3 min [T3], 6 min [T4], 9 min [T5], 12 min [T6], 15 min [T7], 30 min [T8], and 45 min [T9] during the procedure), successful recanalization, time metrics (time interval from stroke onset to catheterization laboratory, catheterization laboratory to groin puncture, and groin puncture to recanalization), vasopressor use, satisfaction score of the neurointerventionalist, complications (pneumonia, other infections, vessel perforation, vessel dissection, distal thrombus, and symptomatic intracerebral hemorrhage, defined as worsening involving NIHSS score ≥1 within 7 days after hemorrhage), the conversion rate from CS to GA, Alberta Stroke Program Early CT Score (ASPECTS) and NIHSS score |
| Safety outcomes | Adverse events, serious adverse events and death |
| Trials | Sun et al. (26) (NCT02677415) |
| Inclusion criteria | The patients were screened for eligibility if they were admitted with AIS for emergency EVT. The inclusion criteria included patients with age 18 years or older having stroke because of intracranial occlusion, based on single phase, multiphase or dynamic computer tomography angiogram (CTA) or digital subtraction angiography (DSA), at one or more of the following arteries: internal carotid artery (ICA), middle cerebral artery (MCA) segments (M1, and M2) equivalent affecting at least 50% of MCA territory. Patients were eligible only if stroke occurred no more than 6 h from the onset of symptoms and who were previously functionally independent (mRS 0 to 2) |
| Exclusion criteria | We excluded patients who were moribund with Glasgow coma scale (GCS) score < 8, requiring tracheal intubation for airway protection and lung ventilation. Patients with intracerebral hemorrhage on brain imaging, severely agitation, having seizures, current NIHSS score < 8 or > 35, or known allergy to specific anesthetics (propofol), or analgesics (sufentanil and remifentail) were excluded from the study |
| Study design | The CANVAS pilot trial is single-center prospective, randomized, open-label, blinded end-point (PROBE) evaluation and enrolled patients with AIS from Beijing Tiantan Hospital, Capital Medical University between April 2016 and June 2017 |
| Efficacy outcomes | mRS after 90 days; favorable outcomes (mRS 0–2); mRS after 30 days; NIHSS after 24 h; NIHSS after 7 days; Reperfusion rate (mTICI 2b-3); Length of ICU stay; Workflow time in mins (symptom to the door; door to arterial puncture; arterial puncture to reperfusion; symptom to reperfusion) |
| Safety outcomes | Adverse events, serious adverse events and death |
| Trials | Maurice et al. (22) (NCT02822144) |
| Inclusion criteria | We studied patients older than 18 years who had given written informed consent and who were admitted to a participating center for occlusion of a large vessel in the anterior cerebral circulation, admitted for endovascular therapy,17 and affiliated with a social security system |
| Exclusion criteria | Non-inclusion criteria included patients who were already intubated and mechanically ventilated before inclusion in the study; had intracerebral hemorrhage associated with the ischemic stroke; were contraindicated for conscious sedation (e.g., Glasgow coma scale < 8; agitation preventing patient from staying still during the procedure; deglutition disorder) or succinylcholine (e.g., hyperkalemia, body mass index >35 kg/m2); had known allergies to any of the drugs used for anesthesia or to any of their excipients, uncontrolled hypotension, or life-threatening comorbidity; could not walk; had a previous stroke; were pregnant or breastfeeding; were legally protected adults (e.g., under judicial protection, guardianship, or supervision); or were persons deprived of their liberty] |
| Study design | This was an investigator-initiated, prospective, multicenter, parallel-group, single-blind, randomized, controlled, superiority trial conducted in four centers in France. Patients underwent randomization in a 1:1 ratio to undergo either general anesthesia or conscious sedation. Randomization was centralized and computer generated, and each patient was given a unique randomization number (patient code) |
| Efficacy outcomes | The primary outcome was the neurologic outcome assessed by modified Rankin score between 2 and 6 months after the endovascular treatment. Secondary outcomes were time from stroke onset to groin puncture; time from arrival in the stroke center to groin puncture; technical failure of the endovascular treatment (defined as failure of arterial puncture or catheterization); reperfusion results evaluated by the neuroradiologist (good reperfusion corresponded to a modified treatment in cerebral ischemia scale score of 2b or 3); National Institutes of Health Stroke Scale score at day 1 (i.e., day after the endovascular treatment) and day 7 (or the day the patient left the hospital if scheduled before day 7) |
| Safety outcomes | Adverse events, serious adverse events and death |
| Trials | Liang et al. (28) (NCT03317535) |
| Inclusion criteria | Eligible candidates were patients 18 years and older with acute PCS (basilar artery or vertebral artery) discovered by computed tomography angiography or magnetic resonance angiography whose condition was suitable for recanalization treatment with < 24 h from onset to primary treatment and whose modified Rankin Scale (mRS) score was 2 or lower before the stroke occurred |
| Exclusion criteria | Exclusion criteria included unclear radiological images for identifying infarction and vessel occlusion, anterior circulation occlusion, intracranial hemorrhage, posterior circulation Acute Stroke Prognosis Early Computed Tomography score < 6, pons-midbrain index score 3 or greater, severe agitation or seizures, loss of airway protective reflexes and/or vomiting on admission, intubation before EVT, unconsciousness, known allergy to anesthetics or analgesics, and refusal to participate on the part of the patient or their legal representative. Before recruitment, patients had to obtain agreement from the neuroradiologist and anesthesiologist that they were suitable for GA or CS |
| Study design | This is a double-center randomized parallel-group exploratory Choice of Anesthesia for Endovascular Treatment of Acute Ischemic Stroke in Posterior Circulation (CANVAS II) trial. Enrolled participants were randomized in a 1:1 ratio for treatment with GA or CS |
| Efficacy outcomes | The primary end point was functional independence, defined as an mRS score of 2 or lower at 90 days. Secondary outcomes included changes in NIHSS score from baseline to 30 and 90 days after randomization; modified treatment in cerebral infarction (mTICI) score at baseline and after treatment; conversion rate; all-cause mortality and proportions of complications up to 90 days after randomization; and time-related outcomes, such as treatment time, length of stay in the hospital and intensive care unit, and time from onset to door |
| Safety outcomes | Adverse events, serious adverse events and death |