Effect of Depth of Anaesthesia on Postoperative Cognitive Decline in Patients Undergoing Coronary Artery Bypass Graft Surgery - a Prospectively Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 88
- 试验地点
- 2
- 主要终点
- Incidence of postoperative cognitive decline after bypass surgery
研究概览
简要总结
Post-Operative Cognitive Decline (POCD) is common after cardiac surgery and associated with increased morbidity and mortality. The pathophysiology of POCD is only poorly understood. Causes include hypoperfusion, microemboli and the systemic inflammatory response, which result in a reduction of cerebral oxygen delivery.
Cerebral oxygenation can be monitored non-invasively by measuring frontal lobe oxygen saturation (rSO2).
The bispectral index (BIS) of the electroencephalogram is widely known to measure depth of anaesthesia, and there is a high correlation between BIS, a dimensionless calculated number between 0 and 100, and clinical criteria of sedation. With BIS below 60 recall is extremely low.
The investigators demonstrated recently that inappropriately high levels of anaesthesia may be associated with poorer long-term outcomes in cognition after non-cardiac surgery (Ballard et al. 2012). Whether optimisation of the depth of anaesthesia and cerebral oxygenation has an effect on postoperative cognitive function in patients undergoing cardiac surgery is unknown.
The investigators hypothesize that the incidence of POCD in elderly patients (> 65 years old) at 6 weeks is less with mildly deep anaesthesia (BIS 50 +- 10) and optimised rSO2 (interventions when rSO2 drops below 15% of baseline reading) when compared with current practice (BIS blinded anaesthesia, reflecting moderately to highly deep anaesthesia and blinded rSO2 measurements).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients undergoing elective coronary artery bypass graft surgery
- •patients at 65 years of age and older
排除标准
- •diseases of the central nervous system including dementia
- •inadequate knowledge of English
- •a current or past psychiatric illness
- •current use of tranquilizers or antidepressants
- •severe visual, auditory, or motor handicap
结局指标
主要结局
Incidence of postoperative cognitive decline after bypass surgery
时间窗: Six weeks after bypass surgery
次要结局
- Postoperative Delirium(3-5 days postoperatively)
- Difference in degree of postoperative cognitive decline at 5 days, 6 weeks or 1 year after bypass surgery(5days, 6 weeks or 1 year postoperatively)
- Incidence of postoperative cognitive decline 5 days and 1 year after bypass surgery(Five days and one year postoperatively)
- Postoperative central nervous system and myocardial biochemical markers(up to 48 hours postoperatively)