Effect of Conscious Sedation vs General Anesthesia on Early Neurological Improvement Among Patients With Ischemic Stroke Undergoing Endovascular Thrombectomy

Abstract

IMPORTANCE Optimal management of sedation and airway during thrombectomy for acute ischemic stroke is controversial due to lack of evidence from randomized trials. OBJECTIVE To assess whether conscious sedation is superior to general anesthesia for early neurological improvement among patients receiving stroke thrombectomy. DESIGN, SETTING, AND PARTICIPANTS SIESTA (Sedation vs Intubation for Endovascular Stroke Treatment), a single-center, randomized, parallel-group, open-label treatment trial with blinded outcome evaluation conducted at Heidelberg University Hospital in Germany (April 2014-February 2016) included 150 patients with acute ischemic stroke in the anterior circulation, higher National Institutes of Health Stroke Scale (NIHSS) score (>10), and isolated/combined occlusion at any level of the internal carotid or middle cerebral artery.INTERVENTION Patients were randomly assigned to an intubated general anesthesia group (n = 73) or a nonintubated conscious sedation group (n = 77) during stroke thrombectomy.MAIN OUTCOMES AND MEASURES Primary outcome was early neurological improvement on the NIHSS after 24 hours (0-42 [none to most severe neurological deficits; a 4-point difference considered clinically relevant]). Secondary outcomes were functional outcome by modified Rankin Scale (mRS) after 3 months (0-6 [symptom free to dead]), mortality, and peri-interventional parameters of feasibility and safety. RESULTS Among 150 patients (60 women [40%]; mean age, 71.5 years; median NIHSS score, 17), primary outcome was not significantly different between the general anesthesia group (mean NIHSS score, 16.8 at admission vs 13.6 after 24 hours; difference, −3.2 points [95% CI, −5.6 to −0.8]) vs the conscious sedation group (mean NIHSS score, 17.2 at admission vs 13.6 after 24 hour; difference, −3.6 points [95% CI, −5.5 to −1.7]); mean difference between groups, −0.4 (95% CI, −3.4 to 2.7; P = .82). Of 47 prespecified secondary outcomes analyzed, 41 showed no significant differences. In the general anesthesia vs the conscious sedation group, substantial patient movement was less frequent (0% vs 9.1%; difference, 9.1%; P = .008), but postinterventional complications were more frequent for hypothermia (32.9% vs 9.1%; P < .001), delayed extubation (49.3% vs 6.5%; P < .001), and pneumonia (13.7% vs 3.9%; P = .03). More patients were functionally independent (unadjusted mRS score, 0 to 2 after 3 months [37.0% in the general anesthesia group vs 18.2% in the conscious sedation group P = .01]). There were no differences in mortality at 3 months (24.7% in both groups).CONCLUSIONS AND RELEVANCE Among patients with acute ischemic stroke in the anterior circulation undergoing thrombectomy, conscious sedation vs general anesthesia did not result in greater improvement in neurological status at 24 hours. The study findings do not support an advantage for the use of conscious sedation.

Effect of general anaesthesia on functional outcome in patients with anterior circulation ischaemic stroke having endovascular thrombectomy versus standard care: a meta-analysis of individual patient data

“…This is in contrast to the highly protocol-specified approach to both GA and conscious sedation in the SIESTA, ANSTROKE and GOLIATH trials. [3][4][5] In particular, strict attention to maintaining systolic blood pressure >140mmHg throughout the procedure (including during anaesthetic induction) may have been critical to preserving collateral blood flow to the ischaemic penumbra and preventing a harmful effect of GA. There were also specified criteria to prevent hyper or hypoventilation.…”

“…In contrast, three small single-centre randomised trials which compared GA, performed using strict protocols to maintain blood pressure, with conscious sedation using the same agents at lower doses without intubation did not detect a signal of harm and functional independence was either no different or slightly increased in the GA patients. [3][4][5] We analysed the pooled individual patient data from available randomised trials to assess whether a treatment benefit was preserved in patients treated under GA in broader contemporary practice. …”

e-ASPECTS Correlates with and Is Predictive of Outcome after Mechanical Thrombectomy

“…Since April 2014, eligible patients were included in our singlecenter randomized sedation trial, Sedation vs. Intubation for Endovascular Stroke TreAtment (SIESTA). 16 After the procedure, all patients were treated according to in-house standardized operating procedures in our neurointensive care unit and/or our stroke unit. In our data base, clinical data at baseline and during the hospital stay as well as radiologic and laboratory information are prospectively entered and used for analysis when appropriate.…”

Predicting Outcomes in the Era of Endovascular Therapy

“…20 However, the recently randomized controlled trial comparing local anesthesia to general anesthesia during thrombectomy did not demonstrate any significant difference in patients outcomes. 21 Therefore, having a reliable, easy-to-administer tool able to predict patient long-term prognosis would be an extremely valuable tool for both future randomized controlled trials and clinical decision-making in acute stroke treatment.…”