Taking Brain Monitoring to the Next Level
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Postoperative cognitive dysfunction
研究概览
简要总结
This one arm clinical study will assess the impact of a goal directed therapy intervention, aiming at optimizing depth of anesthesia and intraoperative blood pressure on the incidence of postoperative cognitive dysfunction and delirium relative to a standardized anesthetic plan. We will enroll 60 patients and will measure the neurocognitive status (MoCA test) of patients before and after surgery (at discharge, within 2 weeks after surgery and 6 months after surgery) to determine the relative impact of anesthetic care on the development of postoperative delirium and cognitive decline. All patients will have a brain scan (fMRI) before and after surgical intervention. Patients will also be asked to participate in an optional blood draw which will take place during their brain imaging visit and post operatively (within 2 days after surgery).
详细描述
This study will test the hypothesis that a goal directed therapy intervention, which optimizes depth of anesthesia and intraoperative blood pressure can decrease the incidence of postoperative neurocognitive dysfunction
Subjects will be recruited for the study and the protocol explained. In addition to standard American Society of Anesthesiologists (ASA) monitoring, we will monitor continuous non-invasive blood pressure and 4 lead electroencephalogram (EEG) channels. Patients will receive standardized anesthesia care in addition to a goal directed therapy hemodynamic management (MAP > 60 mmHg) and processed EEG-guided anesthesia (PSI targeted between 30-50).
Neurocognitive testing: In order to assess general cognitive function, the Montreal Cognitive Assessment test will be used. Cognitive function will be measured preoperatively and postoperatively at discharge, 1 month and 6 months after surgery. For delirium measurement, we will administer daily the Confusion Assessment Method (CAM-ICU) for up to 3 days.
The Montreal Cognitive Assessment (MoCA) is a screening tool to assess mild cognitive dysfunction. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructionals skills, conceptual thinking, calculations, and orientation. Time to administer the MoCA is approximately 10 minutes. The total possible score is 30 points; a score of 26 or above is considered normal.
The Wide Range Assessment of Memory and Learning (WRAML2) is a broad-based memory battery that provides a flexible measure of memory functioning and learning and takes approximately 45-60 minutes to administer. This assessment will be conducted at the first MRI visit and at the 6 month follow up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •45-75 years old,
- •undergoing abdominal, orthopedic, gynecological, or urological surgery
- •expected to stay in hospital for at least 24hours
排除标准
- •Substantial hearing impairment or inability to understand English, since there needs to be neurocognitive testing done
- •status post craniotomy
- •severe dementia
结局指标
主要结局
Postoperative cognitive dysfunction
时间窗: 6 months after surgery.
Montreal Cognitive Assessment (MoCA) test
Postoperative Delirium
时间窗: Daily for up to 3 days postoperatively
Confusion Assessment Method (CAM-ICU)
次要结局
- Examining brain changes II(postoperatively within 2 weeks of surgery)
- Examining brain changes III(6 months post surgery)
- Examining brain changes(Typically less than 15 days before surgery, when the patient comes for the preoperative evaluation, postoperatively at up to 48 hours after surgery, and 6 months post surgery)
- Blood anti-inflammatory biomarkers(post-operatively (within 2 days of surgery))
研究者
Rajesh Kumar, PhD
Professor In-Residence
University of California, Los Angeles