研究动态
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急性缺血性中风患者内镜治疗中采用程序性镇静或全身麻醉的效果:AMETIS随机临床试验。

Outcomes After Endovascular Therapy With Procedural Sedation vs General Anesthesia in Patients With Acute Ischemic Stroke: The AMETIS Randomized Clinical Trial.

发表日期:2023 Apr 03
作者: Russell Chabanne, Thomas Geeraerts, Marc Begard, Baptiste Balança, Francesca Rapido, Vincent Degos, Benoit Tavernier, Serge Molliex, Lionel Velly, Franck Verdonk, Anne-Claire Lukaszewicz, Pierre-François Perrigault, Jean-François Albucher, Christophe Cognard, Adrien Guyot, Charlotte Fernandez, Aurélie Masgrau, Ricardo Moreno, Anna Ferrier, Samir Jaber, Jean-Etienne Bazin, Bruno Pereira, Emmanuel Futier,
来源: JAMA Neurology

摘要:

全麻和程序性镇静常用于急性缺血性卒中机械取栓术。然而,每种策略的风险和效益尚不清楚。该开放标签、盲目终点随机临床试验于2017年8月至2020年2月在法国的10个中心进行,最后的随访时间为2020年5月,招募了颈内动脉和/或近端中动脉闭塞接受取栓术治疗的成年患者。患者被分配接受气管插管全麻(n = 135)或程序性镇静(n = 138)。预定的主要复合结局是90天功能独立(修订Rankin量表上0至2分,范围为0 [无神经功能障碍]至6 [死亡])和无重大术中并发症(与手术有关的严重不良事件、肺炎、心肌梗死、心源性急性肺水肿或恶性卒中)在7天内。在可评估主要结局的273名修正意图治疗人群中,有142名女性(52.0%),平均(SD)年龄为71.6(13.8)岁。在接受全麻的135名患者中,38名(28.2%)发生了主要结局,在接受程序性镇静的138名患者中有50名(36.2%)发生了主要结局,两者之间的绝对差异为8.1个百分点;95%CI区间为-2.3至19.1;P = .15 。90天时,全麻和程序性镇静分别与33.3%(45/135)和39.1%(54/138)的患者实现功能独立(相对风险1.18;95%CI区间0.86-1.61;P = .32)。7天时无重大术中并发症的患者比例分别为65.9%(89/135)和67.4%(93/138)(相对风险1.02;95%CI区间0.86-1.21;P = .80)。对于接受前循环大血管闭塞急性缺血性卒中机械取栓术治疗的患者,全麻和程序性镇静与功能独立和主要术中并发症的发生率相似。 ClinicalTrials.gov标识符:NCT03229148。
General anesthesia and procedural sedation are common practice for mechanical thrombectomy in acute ischemic stroke. However, risks and benefits of each strategy are unclear.To determine whether general anesthesia or procedural sedation for anterior circulation large-vessel occlusion acute ischemic stroke thrombectomy are associated with a difference in periprocedural complications and 3-month functional outcome.This open-label, blinded end point randomized clinical trial was conducted between August 2017 and February 2020, with final follow-up in May 2020, at 10 centers in France. Adults with occlusion of the intracranial internal carotid artery and/or the proximal middle cerebral artery treated with thrombectomy were enrolled.Patients were assigned to receive general anesthesia with tracheal intubation (n = 135) or procedural sedation (n = 138).The prespecified primary composite outcome was functional independence (a score of 0 to 2 on the modified Rankin Scale, which ranges from 0 [no neurologic disability] to 6 [death]) at 90 days and absence of major periprocedural complications (procedure-related serious adverse events, pneumonia, myocardial infarction, cardiogenic acute pulmonary edema, or malignant stroke) at 7 days.Among 273 patients evaluable for the primary outcome in the modified intention-to-treat population, 142 (52.0%) were women, and the mean (SD) age was 71.6 (13.8) years. The primary outcome occurred in 38 of 135 patients (28.2%) assigned to general anesthesia and in 50 of 138 patients (36.2%) assigned to procedural sedation (absolute difference, 8.1 percentage points; 95% CI, -2.3 to 19.1; P = .15). At 90 days, the rate of patients achieving functional independence was 33.3% (45 of 135) with general anesthesia and 39.1% (54 of 138) with procedural sedation (relative risk, 1.18; 95% CI, 0.86-1.61; P = .32). The rate of patients without major periprocedural complications at 7 days was 65.9% (89 of 135) with general anesthesia and 67.4% (93 of 138) with procedural sedation (relative risk, 1.02; 95% CI, 0.86-1.21; P = .80).In patients treated with mechanical thrombectomy for anterior circulation acute ischemic stroke, general anesthesia and procedural sedation were associated with similar rates of functional independence and major periprocedural complications.ClinicalTrials.gov Identifier: NCT03229148.