Monitoring of Anesthesia Depth Reduces the Incidence of Postoperative Delirium and Preserves Memory Abilities Better in the High Risk Elderly
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 2
- 主要终点
- awareness, memory function
研究概览
简要总结
This study aimed to determine whether targeting bispectral index (BIS) readings of 55 (light anaesthesia) was associated with a lower incidence of delirium, dementia (POD), POCD and mortality but higher rates of awareness and complications than a standard of care anaesthesia blinded to depth monitoring.
详细描述
Design: Randomised-controlled, double blind study, monocentric Setting: Level 2 medical center, major surgery (non cardiac) Ethics: Ethical approval for this study (Ethikkommission II der Ruprecht-Karls-Universität Heidelberg 2013-627N-MA) was provided by the Ethical Committee II University Medicine Mannheim, University of Heidelberg, Germany (Chairperson Prof W. Striebel) on Mai 12th 2008.
Patients: n=130, aged > 70y Intervention: Light anesthesia (BIS 55 +/-5) vs. Standard of Care (BIS- blinded) Main outcome measures: Incidence of awareness, delirium, postoperative cognitive deficit (POCD), dementia (POD), memory (MAT with a computerized score for verbal working&short term, figural working&short term memories and well as attention level) Second aims: mortality, complications
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, Investigator, Outcomes Assessor)
盲法说明
group blinding for all of the above except for staff anesthesiologist of the light anesthesia group
入排标准
- 年龄范围
- 70 Years 至 110 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •scheduled for major surgery above 60 min duration
- •informed consent
排除标准
- •emergency surgery with large blood loss and/or preoperative cardiovascular instability, scheduled regional or neuraxial anesthesia, language barriers with the unability to understand a German audio tape, unability or unwillingness to consent,hearing disabilities
结局指标
主要结局
awareness, memory function
时间窗: 1 to 3 days postoperative
implicit and explicit memory for intraoperative wakefulness and memory functions in general as changing conditions due to anesthesia
postoperative dementia and cognitive deficit By MMSE and MAT Test
时间窗: 6 to 24 months
in the hospital by MMSE and MAT (automated computerized test), after discharge by a standardized questionnaire
postoperative delirium by NUDESC
时间窗: 6 to 24 months
in the hospital with NUDESC Score
次要结局
- mortality and morbidity(6 to 24 months)
研究者
Thomas Frietsch
Associate Professor
Heidelberg University