脳卒中に対する血管内血栓回収療法におけるプロポフォールとセボフルラン全身麻酔の比較無作為化比較試験の実現可能性：パイロットスタディ

Although general anesthesia is commonly utilized for endovascular thrombectomy for acute ischemic stroke, whether anesthetic agents affect clinical outcome is unknown. Retrospective studies comparing propofol and volatile agents have shown mixed results. A randomized controlled trial is needed to determine whether anesthetic agent affects clinical outcomes. This pilot study aimed to evaluate the feasibility of conducting a definitive randomized controlled trial comparing propofol and sevoflurane-based anesthesia in patients undergoing endovascular thrombectomy.

Patients booked to undergo endovascular thrombectomy were randomized to receive either propofol or sevoflurane-based general anesthesia. Feasibility outcomes assessed were recruitment rate, protocol adherence, and data completeness. Secondary outcomes included functional recovery (90-d modified Rankin Scale 0 to 2), mortality, early neurological improvement, blood pressure control intraoperatively and postoperatively, and adverse events. We also assessed for independent risk factors for functional recovery and death.

Of 201 eligible patients, 93 (46.3%) were enrolled and 73 (36.3%) included in the final analysis. The consent and randomization model was challenging. Adherence to drug protocols was 94.5%. Data completion rate was 99%. There were no differences in secondary outcomes between groups. Mortality was associated with higher admission National Institutes of Health Stroke Scale. Higher 90-day modified Rankin scores were associated with higher systolic blood pressures pre-reperfusion (r=0.32, P<0.01) and post-reperfusion (r=27, P=0.03).

A definitive randomized controlled trial of propofol and sevoflurane-based anesthesia is feasible. Future studies would benefit from adapting the trial model to better integrate research into the clinical workflow.

Australian New Zealand Clinical Trials Registry (ACTRN12621000074897), January 29, 2021.