Mode of Sedation During Endovascular Treatment of Vertebrobasilar Stroke
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 128
- 试验地点
- 2
- 主要终点
- Functional outcome as measured by modified Ranking Scale (mRS) after admission.
研究概览
简要总结
Optimal anesthetic mode is not established for patients with vertebrobasilar stroke undergoing endovascular treatment. We want to investigate whether a procedural sedation mode approach is feasible compared to general anesthesia
详细描述
Endovascular treatment has become standard of care for many patients with acute ischemic strokes due to large vessel occlusions and is recommended by several national and international guidelines. Several studies have shown that anesthetic modality during endovascular treatment might affect the functional outcome. While much evidence has been generated for ischemic stroke of the anterior circulation, only a few studies have investigated anesthetic modalities in strokes with occlusions of the vertebrobasilar arteries. The majority of patients with vertebrobasilar occlusion strokes undergo endovascular procedure in general anesthesia and not a less burdensome sedation despite the lack of evidence for that approach. A few retrospective studies and a small single-center prospective randomized trial investigating this topic indicate that primary procedural sedation might be a feasible anesthetic approach. Here we aim to provide further high-level evidence by conducting a prospective randomized clinical trial with a PROBE (parallel-group, open-label randomized controlled with blinded endpoint evaluation) design for this research question.
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
- •Decision for thrombectomy according to local protocol for acute recanalizing stroke treatment
- •Age 18 years or older, either sex
- •National Institutes of Health Stroke Scale (NIHSS) ≥ 4
- •Acute ischemic stroke in the posterior circulation with isolated or combined occlusion of vertebral artery (VA) and basilar artery (BA)
- •Informed consent by the patient him-/herself or his/her legal representative obtainable within 72 h of treatment (deferred consenting procedure)
排除标准
- •Intracerebral hemorrhage
- •Coma on admission (Glasgow Coma Scale ≤ 8)
- •Severe respiratory instability, loss of airway protective reflexes or vomiting on admission, where primary intubation and general anesthesia is deemed necessary
- •Intubated state before randomization
- •Severe hemodynamic instability (e.g. due to decompensated cardiac insufficiency)
结局指标
主要结局
Functional outcome as measured by modified Ranking Scale (mRS) after admission.
时间窗: 90 days +/- 2 weeks
0-6; higher mean worse outcome
次要结局
- Early neurological improvement indicated by change of National Institute of Health Stroke Scale (NIHSS) Score 24 hours after admission([NIHSS on admission - NIHSS after 24 hours])
- Mortality(intra-hospital until discharge up to 2 weeks [yes/no] and over the whole follow-up period up to 3 months [time to event])
- Postinterventional pc-ASPECTS, determined with CT or MRI post-interventional follow up scan(12-36 hours after admission)
- Complications before/during and after EST(duration of the whole hospital stay in days)
- Feasibility of EST(duration of thrombectomy procedure in minutes)
研究者
Dr. Silvia Schönenberger, MD
Head of Section of Neurointensive Care
University Hospital Heidelberg