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
- 1
- 主要终点
- postoperative dementia and cognitive deficit By MMSE and MAT Test
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
研究组 & 干预措施
Bis Guided light anesthesia
Patients are monitored by bispectral index and held under light anesthesia (BIS level 45 to 60)
干预措施: BIS guidance of anesthesia (Device)
Standard of Care
Patients receive standard of care anesthesia, BIS monitor was covered with a blind
干预措施: Standard of Care (Other)
结局指标
主要结局
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
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 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