Impact of Tight Intraoperative Blood Pressure and Depth of Anesthesia Control on the Incidence of Postoperative Cognitive Impairment in Elderly Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- postoperative delirium detected by the Confusion Assessment Method (CAM)
研究概览
简要总结
The aim of this study is to demonstrate that in elderly and frail patients, a narrower control of intraoperative blood pressure (BP) by the use of a continuous and noninvasive BP monitoring, coupled with an adequate depth of anesthesia, will reduce the incidence of postoperative cognitive impairment and the hospital length of stay.
详细描述
Postoperative cognitive impairment (delirium and cognitive dysfunction) are frequent and feared complications in the elderly; they increase the postoperative morbidity and mortality, worsen the cognitive and functional outcome with loss of independence and increase the hospitalization length and costs . However, the etiology of these postoperative cognitive impairment, although probably multifactorial, remains unclear and strongly debated.
The investigators hypothesize that excessive anesthesia depths associated with intraoperative hypotension may play a critical role in the pathogenesis of cognitive impairment following surgery.
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
- Single (Participant)
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •elderly patients (over the age of 70) undergoing elective moderate risk surgery requiring a general anesthesia
- •Patients who provide written informed consent
- •patient fluent in french
排除标准
- •Patients under 70 years of age
- •Surgery under locoregional anesthesia or emergent surgery or minor risk surgery
- •Patients requiring invasive blood pressure monitoring (for medical reason or high risk surgery)
- •Patients with arrhythmia and/or atrial fibrillation
- •Patients with preoperative delirium or cognitive dysfunction (moca test < 26)
- •Patients not fluent in French
- •Patients without the capacity to give written informed consent or refusal of consent
- •Patients undergoing surgery or included in another protocol within 3 months
研究组 & 干预措施
Sham
Elderly scheduled for moderate risk surgery Depth of anesthesia monitoring and Continuous non invasive blood pressure monitoring blinded to the anesthesia provider
干预措施: moderate risk surgery (Procedure)
Control
elderly non scheduled for surgery
Monitoring
Elderly scheduled for moderate risk surgery Depth of anesthesia monitoring and Continuous non invasive blood pressure monitoring accessible to the anesthesia provider.
干预措施: Depth of anesthesia monitoring (BIS, Covidien USA) and Continus non invasive blood pressure monitoring (Clearsight, Edwards LifeScience, USA) (Device)
Monitoring
Elderly scheduled for moderate risk surgery Depth of anesthesia monitoring and Continuous non invasive blood pressure monitoring accessible to the anesthesia provider.
干预措施: moderate risk surgery (Procedure)
结局指标
主要结局
postoperative delirium detected by the Confusion Assessment Method (CAM)
时间窗: 3 day postoperative
Screening of postoperative delirium by the CAM, every day until the 3rd postoperative day
次要结局
- postoperative change in cognitive function detected by a battery of neuropsychological test.(baseline and 1 week and 3 month postoperative)
研究者
Céline Boudart
MD
Erasme University Hospital