Assessing the Impact of the Implementation of BIS on the Incidence of Postoperative Delirium - A Monocentre Prospective Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 1,400
- 试验地点
- 1
- 主要终点
- Incidence of POD
研究概览
简要总结
This study will investigate the incidence of postoperative POD in patients undergoing non cardiac surgery under general anesthesia with and without the implementation of the BIS monitoring.T
详细描述
This study will compare the incidence of POD after elective non cardiac surgery conducted under general anesthesia before and after the implementation of BIS monitoring in our University Hospital.
The POD will be evaluated with the CAM and Nu-DESC tools, which have been adapted for the greek population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult patients over 60 years of age
- •an American Society of Anesthesiologists (ASA) physical status I to III
- •undergoing elective non cardiac surgery under general anaesthesia
- •native speakers of the Greek language
- •eligible to leave the post-anaesthesia care unit
- •an expected in-hospital stay at least 24 hours following surgery
排除标准
- •refused to participate or sign the informed consent form
- •surgery or anaesthesia within the last 30 day
- •any prior or current history involving an affliction of the central nervous system
- •severe hearing or visual impairment
- •psychiatric disorders
- •a score less than 5 according the Geriatric Depression Scale (GDS-15)
- •a score less than 4 for females and less than 2 for males according to the Lawton-Brody Instrumental Activities of Daily Living Scale (I.A.D.L.)
- •alcohol consumption less than 35 units/week
- •drug dependence
- •previous neuropsychological testing
- •haemodynamical instability
- •peri-procedural desaturation (one or more events of SpO2<80% for more than 2 minutes)
研究组 & 干预措施
POD without BIS
Assessing the incidence of POD in patients under general anethesia for elective non cardiac surgery, with CAM and Nu-DESC tools.
POD with BIS
Assessing the incidence of POD in patients under general anethesia for elective non cardiac surgery with the implementation of BIS monitoring, with CAM and Nu-DESC tools.
干预措施: BIS (Device)
结局指标
主要结局
Incidence of POD
时间窗: 1st postoperative day
Assess the incidence of POD with CAM and Nu-DESC tools
次要结局
未报告次要终点
研究者
Elena Arnaoutoglou
Professor of Anesthesiology
University of Thessaly