Sedation vs General Anesthesia for Endovascular Therapy in Acute Ischemic Stroke: The SEGA Randomized Clinical Trial.

Importance: The optimal anesthetic strategy for patients undergoing endovascular therapy (EVT) for acute ischemic stroke (AIS) from large vessel occlusion (LVO) remains unclear. Objective: To determine if general anesthesia (GA) or moderate sedation for patients who undergo EVT for AIS with LVO is associated with a different functional outcome in 90 days. Design, Setting, and Participants: This was a multicenter randomized clinical trial conducted from July 2018 to August 2023 of patients with AIS who were receiving EVT due to LVO. Patients were recruited from 10 comprehensive stroke centers in the US. Adult patients with occlusion of the carotid artery and the proximal middle and anterior cerebral artery who underwent EVT were eligible for enrollment. Interventions: Patients were randomized to receive either moderate sedation or GA in 1:1 ratio. Main Outcomes and Measures: The primary outcome was the ordinal modified Rankin Scale (mRS) score at 90 days. Results: A total of 1931 patients were screened for eligibility, and 1671 were excluded due to failure meeting the inclusion criteria. Among 260 individuals with a mean (SD) age of 66.8 (13.3) years included in this intention-to-treat study, 133 were male (52%), and 130 (50%) were randomized to GA and sedation each. At 90 days, a shift in the distribution of ordinal mRS was found favoring GA (odds ratio [OR], 1.22; 95% credible interval [CrI], 0.79-1.87) with an 81% posterior probability of GA superiority. The probability that GA was superior to sedation was 89% (relative risk [RR], 1.2; 95% CrI, 0.9-1.66) and 69% (RR, 1.01; 95% CrI, 0.96-1.08) for 90-day mRS 0 to 2 and successful reperfusion, respectively. Other secondary outcomes were similar. Symptomatic intracerebral hemorrhage was 0.8% (1 of 125 patients) in GA vs 2.4% (3 of 125 patients) in sedation with a posterior probability of GA was superior to sedation of 72% (RR, 0.71; 95% CrI, 0.23-2.16). Conclusions and Relevance: This randomized clinical trial found that patients with LVO AIS who were treated with EVT using GA had improved rates of 90-day outcomes and higher rates of successful reperfusion compared with those treated using moderate sedation. Trial Registration: ClinicalTrials.gov Identifier: NCT03263117.