Target-controlled Total Intravenous Anesthesia With Propofol Versus Sevoflurane Anesthesia for Endovascular Thrombectomy Procedure in Acute Ischemic Stroke Patients: Comparison of the Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 298
- 试验地点
- 2
- 主要终点
- Change in Cognitive function and delirium evaluation
研究概览
简要总结
The present clinical trial compares the effect of two general anesthesia (GA) modalities, the one with volatile anesthetic sevoflurane (endotracheal-intubated) and the other integrating total intravenous anesthesia (TIVA) with propofol (non-intubated), on post-procedural delirium and cognitive dysfunction after endovascular thrombectomy (EVT) in the participants with acute ischemic stroke. To assess the outcome of both modalities, the sedation depth of GA will be regulated with processed electroencephalogram monitor to reduce the incidence of postoperative delirium and the peri-procedural blood pressure will be controlled according to the guideline.Based on that, the investigators try to find a better general anesthetic modality for acute ischemic stroke participants undergoing EVT.
详细描述
- In 2019, cerebrovascular disease (i.e., stroke) was the second leading cause of death worldwide.
- The present guidelines for the early management of the participants with acute ischemic stroke urge the in-time and early application of intravenous chemical thrombolysis and endovascular thrombectomy (EVT) due to better outcome and prognosis. "Timing is brain."
- The participants with acute ischemic stroke, previous stroke, and severe stroke have high incidence of delirium, and the stroke-related delirium has been shown to correlate with higher morbidity and mortality.
- Researches on the anesthetic management during EVT for acute ischemic stroke have shown that both general anesthesia and sedation anesthesia are safe and without difference in neurological outcome and long-term complications. However, general anesthesia might have higher rates in revascularization in EVT for acute ischemic stroke as compared with sedation anesthesia.
- Anesthesia could produce postoperative cognitive dysfunction (POCD) or delirium (POD), and general anesthesia could produce higher rates of POCD and POD compared to general anesthesia and sedation anesthesia. Additionally, brain injury and acute ischemic stroke are independent risk factors for POCD and POD. Whether the anesthetic management for EVT would interfere with the acute ischemic stroke-produced POCD and/or POD or even delay the detection and treatment of stroke-related neurological impairment deserves investigation since EVT is the gold standard for acute ischemic stroke.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Patients who meet the enrollment criteria and who provide written informed consent will be randomly assigned to either of the intubated Sev-GA or non-intubated TIVA-propofol groups according to either the discretion of anesthesiologist in charge or random allocation. If the patient was in critical situation, uncooperative, or with uncontrolled movement, the anesthesiologist would choose the intubated Sev-GA instead of the scheduled randomization. However, if patient is cooperative and not critical, the patient would be randomly assigned according to the randomization list created with the use of computer-generated, permuted-block sequences. Only the anesthesiologist and physicians involved in EVT are aware of the anesthesia assignment. On the contrary, patients, personnel who collect data, fill out questionnaire and scale measurement, and personnel who assess outcomes are unaware of the group assignments.
入排标准
- 年龄范围
- 20 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of acute ischemic stroke with large vessel occlusion who are scheduled to undergo endovascular thrombectomy procedure, and
- •Must be age of 20 to 90
- •Must fulfill the indications for endovascular thrombectomy in acute ischemic stroke according to the American Heart Association/American Stroke Association 2018 Guidelines for the early management of patients with acute ischemic stroke and 2019 Taiwan stroke society guideline for endovascular thrombectomy in acute ischemic stroke, and
- •Must agree to enroll into the clinical trial and sign the written informed consent from patients or delegates
排除标准
- •Allergy to allergy to the anesthetics used in this clinical study
- •Refusal for enrolling in study
结局指标
主要结局
Change in Cognitive function and delirium evaluation
时间窗: Month 3 after procedure
Cognitive functions (including delirium) will be assessed with the confusion assessment method. It is a validated delirium diagnostic tool, and is considered the "gold standard" for detection of delirium.: The four features of delirium are:1) acute onset and fluctuating course, 2) inattention, 3) disorganized thinking and 4) altered level of consciousness. A positive diagnosis of delirium is made if the person has feature 1 \& 2 plus either 3 or 4. A positive diagnosis of delirium means that the patient's outcome is poor.
次要结局
- Neurological function: modified Rankin scale(Month 3 after procedure)
- Neurological function: National Institute of Health Stroke Scale(Month 3 after procedure)