General Anesthesia Versus Sedation During Intra-arterial Treatment for Stroke
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 351
- 试验地点
- 4
- 主要终点
- Score on the modified Rankin scale
研究概览
简要总结
In France, the annual incidence rate of acute ischaemic stroke is around 150 000 patients, 65 % of whom keep long-term disability. Several multicentric randomized controlled trials have shown the benefit of a mechanical thrombectomy in the acute phase of ischaemic stroke on functional disability, compared to a medical treatment alone (thrombolysis).
The timeliness of revascularisation is an essential factor of good prognosis. This intra-arterial treatment, associated with thrombolysis if applicable, is the reference treatment of large-vessel occlusion. The stillness of the patient is required to control the safety of the recanalization. Currently, either a general anesthesia or a sedation can be performed.
Several studies have shown a trend to superiority of the sedation but none was conducted with a high level of proof methodology.
The aim of our multicentric randomized controlled trial is to compare sedation and general anesthesia during intra-arterial thrombectomy for an acute ischaemic stroke in the anterior cerebral circulation. The main outcome will be the efficacy on the functional neurological prognosis at 3 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years
- •Body mass index < or equal to 35 kg/m² ,
- •Indication for thrombectomy, after multidisciplinary consultation,
- •Proximal artery occlusion in the anterior circulation (internal carotid artery, M1, M2,...), confirmed on imaging (angioscan or angio-MRI),
- •Written informed consent of the patient or a close / trusted person when possible, or emergency procedure,
- •Patient affiliated to or beneficiary of an health insurance
- •Non-inclusion Criteria:
- •Comorbidity committing short-term prognosis,
- •Hemodynamic instability,
- •Pregnant woman,
- •Contra-indication to sedation: pre-existing swallowing impairment; restless patient, not able to stay lying down; Glasgow score < 8,
- •Contra-indication to general anesthesia,
- •Intubated patient at inclusion,
- •Additional intracerebral hemorrhage,
- •Sign of occlusion in a different cerebral territory,
- •Known contra-indication to succinylcholine: hypersensitivity, hyperkaliemia,
- •Known contra-indication to one of the anesthesic agents,
- •Patient participating in another clinical trial, possibly interfering with the study procedures,
- •Patient in a known situation of deprivation of freedom, guardianship or curatorship.
- •Exclusion criteria:
- •Patients with deprivation of freedom will be excluded as soon as the investigator will have knowledge of the situation.
排除标准
- 未提供
研究组 & 干预措施
general anesthesia
General anesthesia with etomidate, succinylcholine, propofol and remifentanil
干预措施: Etomidate (Drug)
general anesthesia
General anesthesia with etomidate, succinylcholine, propofol and remifentanil
干预措施: Succinylcholine (Drug)
general anesthesia
General anesthesia with etomidate, succinylcholine, propofol and remifentanil
干预措施: Propofol (Drug)
general anesthesia
General anesthesia with etomidate, succinylcholine, propofol and remifentanil
干预措施: Remifentanil (Drug)
sedation
Sedation with remifentanil and local anesthesia with lidocaine
干预措施: Remifentanil (Drug)
sedation
Sedation with remifentanil and local anesthesia with lidocaine
干预措施: Lidocaine (Drug)
结局指标
主要结局
Score on the modified Rankin scale
时间窗: 3 months
次要结局
- NIHSS score(Day 7)
- Recanalization delay(Day 1)
- Delay between patient's hospitalization and start of procedure(Day 1)
- Quality of recanalization assessed with TICI (Thrombolysis in cerebral infarction) score(Day 1)
- Angiographic complications: number of patients wtih dissection, arterial rupture, thrombus in another territory(Day 1)
- Mortality(3 months)
- Number of episodes of hypo- / hypertension(24 hours after thrombectomy)
- Number of patients with noradrenaline administration during anesthesia(Day 1)
- Number of sedations converted to general anesthesia and reason(Day 1)