Effect of Prophylactic Application of 40Hz Transcranial Stimulation in AICU on Incidence of Postoperative Delirium in Elderly Patients Undergoing Elective Gastrointestinal Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- The incidence of postoperative delirium
研究概览
简要总结
Postoperative delirium is an acute central nervous system dysfunction caused by surgical stress, which is manifested by postoperative acute, non-specific changes in consciousness level, attention, cognitive ability and disturbance of sleep and wake cycles. It is one of the most common surgical complications in the elderly, occurring in more than 75% of patients receiving mechanical ventilation in the intensive care unit(ICU).Exogenous 40 Hz stimulation can improve cognitive functioning.Therefore, the aim of this study was to investigate the effect of exogenous 40Hz stimulation on the incidence of postoperative delirium in elderly patients undergoing elective gastrointestinal surgery in AICU.
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
- Quadruple (Participant, Care Provider, 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
- •1.Age ≥ 65 years old,gender not limited
- •2.ASA classification Ⅱ ~ Ⅳ
- •3.Elective gastrointestinal general anesthesia surgery
排除标准
- •1.History of schizophrenia, epilepsy, Parkinson's disease, or myasthenia gravis
- •2.Pre-operative coma, severe dementia, speech impairment or severe illness incapacitated and unable to communicate
- •3.Delirium on admission or pre-operative delirium, brain injury
- •4.Severely infected person
- •5.Severe liver dysfunction (Child-Pugh C), severe renal insufficiency (preoperative dialysis)
- •6.Severe hearing or vision impairment
结局指标
主要结局
The incidence of postoperative delirium
时间窗: Day 1, Day 2, Day 3 ,Day 4, Day 5, Day 6,Day 7 after surgery
Postoperative delirium was assessed using the CAM-ICU scale.The RASS score (The Richmond Agitation-Sedation Scale) was used to assess arousal. When the patient's RASS score is not -4 /-5, delirium evaluation can continue considering the patient's wakefulness status.CAM-ICU scale contains four features (Feature 1, Feature 2, Feature 3, and Feature 4). Delirium can be diagnosed when the patient is positive for features 1, 2, 3, or 4.
次要结局
- Blood Markers(half hour, 6hours, 24hours and 48hours after transfer to aicu)
- Sleep quality(8:00 to 10:00 every morning for the first three days after surgery)
- The incidence of pain(6hours, 24hours, 48hours after surgery)