Effect of Postoperative Prolonged Sedation With Dexmedetomidine After Successful Reperfusion With Endovascular Thrombectomy on Long-term Prognosis in Patients With Acute Ischemic Stroke (PPDET)
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 368
- 试验地点
- 1
- 主要终点
- The favorable functional outcome of stroke-related disability rate
研究概览
简要总结
Dexmedetomidine can attenuate the activity of the sympathetic nervous system under stress response and improve ischemia-reperfusion injury. The investigators hypothesized that the prolonged sedation of dexmedetomidine after successful reperfusion of endovascular thrombectomy may improve the clinical outcome of acute ischemic stroke patients.
详细描述
Endovascular treatment with mechanical thrombectomy is the standard treatment for acute large vessel occlusion.
Dexmedetomidine is a commonly used sedative in endovascular thrombectomy of acute ischemic stroke.
Dexmedetomidine can attenuate the activity of the sympathetic nervous system under stress response and improve ischemia-reperfusion injury.
The investigators hypothesized that the prolonged sedation of dexmedetomidine after successful reperfusion of endovascular thrombectomy may improve the clinical outcome of acute ischemic stroke patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •2≤NIHSS≤25
- •mRS score before stroke was less than 3
- •Acute ischemic stroke (including anterior circulation)
- •mTICI rate 2b or 3
- •According to the 2018 AHA/ASA guidelines for the management of acute ischemic stroke, patients who plan to receive mechanical thrombectomy under local anesthesia and sedation
- •Informed consent was signed by patient or legal representative
排除标准
- •Intracerebral hemorrhage occurred in the responsible vessel area in the past 6 weeks
- •Patients who had received stent treatment at the responsible vessel in the past
- •Neurological function was restored at or before angiography
- •Patients who are allergic to heparin, aspirin, clopidogrel, rapamycin, lactic acid polymer, poly (n-butyl methacrylate), stainless steel, anesthetics and contrast agents or have contraindications
- •Hemoglobin was less than 70g/L, platelet count was less than 50×109/L, international normalized ratio (INR) greater than 1.5 (irreversible), there are uncorrectable bleeding factors
- •Blood glucose < 2.7 mmol/L or > 22.2 mmol/L
- •Severe liver or kidney disfunction, ALT>3 times the upper limit of normal value or AST>3 times the upper limit of normal value, creatinine>1.5 times the upper limit of normal value
- •Pregnant or lactating women
- •Previous history of mental illness
- •Stroke with other acute diseases or postoperative stroke of other operation
- •Heart rate less than 50bpm, second or third degree of atrioventricular block (except for pacemaker implantation), systolic blood pressure less than 90mmHg (two vasoactive drugs were already infused continuously )
研究组 & 干预措施
Intervention group
Dexmedetomidine 0.1~1.0 μg/kg/h for 24h after patients finished endovascular thrombectomy and returned to ICU. Maintain Ramsay score 2-3.
干预措施: Dexmedetomidine prolonged sedation (Drug)
Control group
An equal dose of saline 24h after patients finished endovascular thrombectomy and returned to ICU. If the Ramsay sedation score is 1, propofol will be administrated to maintain the Ramsay sedation score at 2 to 3.
干预措施: 0.9% saline (Drug)
结局指标
主要结局
The favorable functional outcome of stroke-related disability rate
时间窗: 90 ± 14 days after thrombectomy
Modified Rankin Scale ≤ 2 points. mRS range from 0 to 6, higher scores mean a worse outcome.
次要结局
- adverse events at 90-day after operation(within 90-day after thrombectomy)
- Length of ICU stay(From the date of admission until discharged from ICU, up to 30 days)
- Changes of National Institute of Health stroke scale(on the 7-day or discharged day whichever comes first, up to 30 days)
- Changes of ischemic penumbra(on the 7-day or discharged day whichever comes first, up to 30 days)
- Length of hospital stay(From the date of admission until discharged from hospital, up to 30 days)
- mortality rate at 90-day after operation(within 90-day after thrombectomy)
研究者
Changwei Wei
Deputy chief physician
Beijing Chao Yang Hospital