Effect of Conscious Sedation vs General Anesthesia on Early Neurological Improvement Among Patients With Ischemic Stroke Undergoing Endovascular Thrombectomy A Randomized Clinical Trial
Effect of Conscious Sedation vs General Anesthesia on Early Neurological Improvement Among Patients With Ischemic Stroke Undergoing Endovascular Thrombectomy A Randomized Clinical Trial
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DOI：
10.1001/jama.2016.16623
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发表时间：
2016-11-15
影响因子：
120.7
通讯作者：
Boesel, Julian
中科院分区：
文献类型：
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作者：
Schoenenberger, Silvia;Uhlmann, Lorenz;Boesel, Julian
由于缺乏随机试验的证据，急性缺血性卒中血栓切除术中镇静和气道的最佳管理存在争议。目的评估清醒镇静是否上级全身麻醉，以改善接受脑卒中血栓切除术患者的早期神经功能。（镇静与插管治疗血管内卒中），一项单中心、随机、平行组研究，在德国海德堡大学医院进行的一项盲态结局评价的开放标签治疗试验（2014年4月至2016年2月）纳入了150例前循环急性缺血性卒中患者，美国国立卫生研究院卒中量表（NIHSS）评分较高（>10），干预患者被随机分配到插管全身麻醉组（n = 10），主要结果和测量主要结果是24小时后NIHSS的早期神经功能改善（0-42 [无至最严重的神经功能缺损; 4分差异被认为是临床相关的]）。次要结局为3个月后改良兰金量表（mRS）的功能结局（0-6 [无症状至死亡]）、死亡率以及围介入期可行性和安全性参数。（60名女性[40%];平均年龄，71.5岁;中位NIHSS评分，17），主要结局在全身麻醉组之间无显著差异（入院时平均NIHSS评分为16.8，24小时后为13.6;差异为-3.2分[95% CI，-5.6至-0.8]）与清醒镇静组相比（入院时平均NIHSS评分为17.2，24小时后为13.6;差异为-3.6分[95% CI，-5.5至-1.7]）;组间平均差异为-0.4（95% CI，-3.4至2.7; P = 0.82）。在分析的47个预先设定的次要结局中，41个显示无显著差异。在全身麻醉组与清醒镇静组相比，患者的实质性运动频率较低（0% vs 9.1%;差异，9.1%; P = .008），但低体温的介入术后并发症更常见（32.9% vs 9.1%; P <0.001）、延迟拔管（49.3% vs 6.5%; P <0.001）和肺炎（13.7% vs 3.9%; P = 0.03）。更多患者功能独立（3个月后未校正的mRS评分为0 - 2 [全麻组37.0% vs清醒镇静组18.2%，P = 0.01]）。3个月时的死亡率没有差异（两组均为24.7%）。结论和相关性在接受血栓切除术的前循环急性缺血性中风患者中，清醒镇静与全身麻醉相比，并没有在数小时内导致神经系统状态的更大改善。该研究不支持使用清醒镇静的优势。
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 hours. The study do not support an advantage for the use of conscious sedation.