Anaesthetic Depth and Short Term Delirium Post Cardiac Surgery Intervention
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- To demonstrate the benefit of reduced depth of anesthesia
研究概览
简要总结
Postoperative delirium (POD) is a critical complication of major surgery and affects up to 70% of surgical patients over the age of 60 years.
The additional healthcare costs associated with delirium exceed €50,000 per patient per year due to prolonged hospital stay, increased risk of long-term care or institutionalization, and the risk of developing dementia or cognitive impairment . Therefore, prevention of POD is a major goal in the perioperative setting.
The investigator proposes this randomized study to evaluate the interest of a reduced anesthetic depth to prevent short-term cognitive disorders after cardiac surgery in elderly subjects.
Method: Patients over 75 years old scheduled to undergo one of the cardiac surgeries of interest (valvular, coronary bypass, aortic or combined surgery) will be randomized to 2 paralell arms :
- Perioperative anesthesia with a BIS (Bispectral index) target of 35
- Perioperative anesthesia with a BIS(Bispectral index) target of 55
The presence of mental confusion will be determined by CAM-ICU ( Confusion Assessment Method for the ICU ) at day 3 post procedure.
Ancillary study: To assess cognitive status at inclusion, discharge and third post operative month using the MOCA(Montreal Cognitive Assessment ).
Conclusion:The hypothesis of this study is that a lower depth of anesthesia will reduce post operative delirium in the first three days in patients older than 75 years who are planned for valvular, coronary artery bypass, aortic or combined cardiac surgery .
详细描述
Multicenter, controlled, randomized trial with two parallel arms (Perioperative anesthesia with a BIS target of 35 / Perioperative anesthesia with a BIS target of 55).
Randomization will be stratified by center, type of surgery (valve vs coronary artery bypass surgery vs aortic surgery vs combined surgery), patient age (75-80 vs 81-85), Euroscore 2 score at inclusion (predicted mortality risk ≥ vs < to 30%).
An ancillary study with MOCA score measurement at inclusion, discharge and 3 months after cardiac surgery will be realized.
Primary Objective:
To demonstrate the benefit of lower anesthesia on the prevalence of delirium during the first 3 days postoperatively in patients aged 75 years and older having cardiac surgery (valvular, coronary bypass, aortic or combined 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
- None
入排标准
- 年龄范围
- 75 Years 至 85 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient aged between 75 and 85 years, who signed an informed consent, undergoing elective valvular, coronary artery bypass, aortic or combined cardiac surgery
- •Be affiliated to French Health Insurance
排除标准
- •Refusal of consent -Patient unable to read, write or understand French
- •Vulnerable patient according to article L1121-6 of the CSP,
- •Patient of legal age under guardianship or curatorship or under legal protection,
- •Patient unable to give personal consent according to article L.1121-8 of the CSP or adult protected by law,
- •Patient having already participated in the present study
研究组 & 干预措施
Perioperative anesthesia with a BIS target of 35
Anesthesia with a BIS target of 35
干预措施: General anesthesia with propofol or sevoflurane (Drug)
Perioperative anesthesia with a BIS target of 35
Anesthesia with a BIS target of 35
干预措施: CAM-ICU (Confusion Assesment Method ICU) at day 3 post-operative (Behavioral)
Perioperative anesthesia with a BIS target of 55
Anesthesia with a BIS target of 55
干预措施: General anesthesia with propofol or sevoflurane (Drug)
Perioperative anesthesia with a BIS target of 55
Anesthesia with a BIS target of 55
干预措施: CAM-ICU (Confusion Assesment Method ICU) at day 3 post-operative (Behavioral)
结局指标
主要结局
To demonstrate the benefit of reduced depth of anesthesia
时间窗: Day 3 post intervention.
The presence of mental confusion using CAM-ICU ( The Confusion Assessment Method for the Intensive Care Unit )
次要结局
未报告次要终点