Optimized Anesthesia to Reduce Incidence of Postoperative Delirium in Elderly Undergoing Elective, Non-cardiac Surgery: a Randomized Controlled Trial (POD-II)
试验速览
- 阶段
- 2 期
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Number of patients have postoperative delirium
研究概览
简要总结
The purpose of this study is to compare the difference of incidence of postoperative delirium between patients received general anesthesia guided by Bispectral index (BIS) and patients received general anesthesia using standard technique.
详细描述
General anesthesia is one of precipitating factor of postoperative delirium which Its mechanism is still unknown. General anesthesia can affect on pattern of electroencephalograph. Previous studies showed that patients received BIS guided anesthesia could wake up faster, earlier extubation and stay in recovery room shorter compared to standard general anesthesia. Optimized level of anesthesia by BIS could reduce cognitive dysfunction in elderly patients and reduce biological marker of brain injury. Therefore, the investigators hypothesized that adjustment of general anesthesia by BIS guided could protect central nervous system and reduce incidence of postoperative delirium.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 95 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients age equal or more than 65 years.
- •Patients undergoing general anesthesia.
- •Patients undergoing scheduled, non-cardiac surgery
排除标准
- •Patients undergoing neurosurgery.
- •Patients cannot understand Thai language.
- •Patients who have severe visual or hearing impairment.
研究组 & 干预措施
Bispectral index (BIS) group
Bispectral index as measured by a BIS Processor is used to guide doses of anesthetic for maintaining the BIS values of 40-60
干预措施: Bispectral index, as measured by a BIS processor (Device)
Control group
Clinical signs is used to guide doses of anestheitics.
结局指标
主要结局
Number of patients have postoperative delirium
时间窗: Participants will be followed during the duration of hospital stay, an expected avarage of two weeks.
Assess postoperative delirium by using Confusion Assessment Method for intensive care unit (CAM-ICU) at recovery room and Confusion Assessment Method at inpatient ward.
次要结局
- Time to recovery(The end of surgery)
- Number of patients with impaired cognitive function(Up to 6 months)
研究者
Dr. Yodying Punjasawadwong
MD
Chiang Mai University