Gough Michael J, Bodenham Andrew, Horrocks Michael, Colam Bridget, Lewis Steff C, Rothwell Peter M, Banning Adrian P, Torgerson David, Gough Moira, Dellagrammaticas Demosthenes, Leigh-Brown Anne, Liapis Christos, Warlow Charles
Vascular Surgical Unit, Leeds General Infirmary, Great George Street, Leeds LS1 3EX, UK.
Trials. 2008 May 21;9:28. doi: 10.1186/1745-6215-9-28.
Patients who have severe narrowing at or near the origin of the internal carotid artery as a result of atherosclerosis have a high risk of ischaemic stroke ipsilateral to the arterial lesion. Previous trials have shown that carotid endarterectomy improves long-term outcomes, particularly when performed soon after a prior transient ischaemic attack or mild ischaemic stroke. However, complications may occur during or soon after surgery, the most serious of which is stroke, which can be fatal. It has been suggested that performing the operation under local anaesthesia, rather than general anaesthesia, may be safer. Therefore, a prospective, randomised trial of local versus general anaesthesia for carotid endarterectomy was proposed to determine whether type of anaesthesia influences peri-operative morbidity and mortality, quality of life and longer term outcome in terms of stroke-free survival.
METHODS/DESIGN: A two-arm, parallel group, multicentre randomised controlled trial with a recruitment target of 5000 patients. For entry into the study, in the opinion of the responsible clinician, the patient requiring an endarterectomy must be suitable for either local or general anaesthesia, and have no clear indication for either type. All patients with symptomatic or asymptomatic internal carotid stenosis for whom open surgery is advised are eligible. There is no upper age limit. Exclusion criteria are: no informed consent; definite preference for local or general anaesthetic by the clinician or patient; patient unlikely to be able to co-operate with awake testing during local anaesthesia; patient requiring simultaneous bilateral carotid endarterectomy; carotid endarterectomy combined with another operation such as coronary bypass surgery; and, the patient has been randomised into the trial previously. Patients are randomised to local or general anaesthesia by the central trial office. The primary outcome is the proportion of patients alive, stroke free (including retinal infarction) and without myocardial infarction 30 days post-surgery. Secondary outcomes include the proportion of patients alive and stroke free at one year; health related quality of life at 30 days; surgical adverse events, re-operation and re-admission rates; the relative cost of the two methods of anaesthesia; length of stay and intensive and high dependency bed occupancy.
Current Controlled Trials ISRCTN00525237.
由于动脉粥样硬化导致颈内动脉起始部或其附近严重狭窄的患者，发生与动脉病变同侧缺血性卒中的风险很高。既往试验表明，颈动脉内膜切除术可改善长期预后，尤其是在先有短暂性脑缺血发作或轻度缺血性卒中后不久进行手术时。然而，手术期间或术后不久可能会出现并发症，其中最严重的是卒中，可能是致命的。有人认为，在局部麻醉而非全身麻醉下进行手术可能更安全。因此，提议开展一项关于颈动脉内膜切除术采用局部麻醉与全身麻醉的前瞻性随机试验，以确定麻醉方式是否会影响围手术期发病率和死亡率、生活质量以及无卒中生存方面的长期预后。
方法/设计：一项双臂、平行组、多中心随机对照试验，招募目标为5000例患者。对于进入研究的患者，在负责的临床医生看来，需要进行内膜切除术的患者必须适合局部麻醉或全身麻醉，且没有明确偏向其中任何一种麻醉方式的指征。所有建议进行开放手术的有症状或无症状颈内动脉狭窄患者均符合条件。没有年龄上限。排除标准为：未获得知情同意；临床医生或患者明确偏向局部或全身麻醉；患者在局部麻醉期间不太可能配合清醒测试；患者需要同时进行双侧颈动脉内膜切除术；颈动脉内膜切除术与另一项手术如冠状动脉搭桥手术联合进行；以及患者先前已被随机纳入该试验。患者由中央试验办公室随机分配至局部麻醉或全身麻醉组。主要结局是术后30天存活、无卒中（包括视网膜梗死）且无心肌梗死的患者比例。次要结局包括术后1年存活且无卒中的患者比例；术后30天与健康相关的生活质量；手术不良事件、再次手术和再次入院率；两种麻醉方法的相对成本；住院时间以及重症监护和高依赖床位占用情况。
当前受控试验ISRCTN00525237。
