The Effect of Stellate Ganglion Block on Postoperative Sleep Disturbance and Cognitive Function in Elderly Surgical Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Changes in the level of actigraphy
研究概览
简要总结
Postoperative delirium is an acute state of confusion, which is characterized by changes in attention and cognitive functions and fluctuations in consciousness; postoperative cognitive dysfunction is a common central nervous system complication in elderly patients after surgery, often manifested as memory, Obstacles in abstract thinking and orientation are accompanied by a decline in social activity ability. Postoperative delirium and cognitive dysfunction can prolong hospital stay, increase medical expenses, affect postoperative functional recovery, and even increase postoperative mortality. Sleep disorders are a group of diseases that affect the ability to sleep well regularly and cause severe impairment of social and occupational functions. Stellate ganglion block is a selective sympathetic ganglion block, in which a local anesthetic is injected into the loose connective tissue of the neck including the stellate ganglion. There are complex connections between stellate ganglia and multiple brain regions in the brain, which can improve postoperative delirium, cognitive function and sleep disturbance to a certain extent, and have certain guiding significance for postoperative rehabilitation of elderly patients.
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)
入排标准
- 年龄范围
- 65 Years 至 85 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 60 years;
- •ASA grade I-III;
- •Operative time ≥ 2 h for laparoscopic radical resection of a suspected; gastrointestinal malignancy.
排除标准
- •Patient's lack of consent to participate;
- •Known allergy to anesthetic drugs;
- •History of psychiatric or neurological disease(s);
- •Long-term use of opioids or sedative-hypnotic drugs;
- •Previous or planned neurosurgical procedures;
- •contraindications to epidural anesthesia;
- •Hearing or visual impairment that precludes scale assessment.
结局指标
主要结局
Changes in the level of actigraphy
时间窗: The 1st night before the operation and the 1st, 2nd and 3rd nights postoperatively
Through the actigraphy, monitor the patient's sleep quality
Changes in the level of Mini-Men-tal State Examination scale score
时间窗: The day before surgery and 1,2,3,5,7 days after surgery
Assess the cognitive function of the patient by asking questions on the patient scale
Changes in the level of Pittsburgh sleep quality index
时间窗: The day before surgery and 1,2,3,5,7 days
Assess the patient's sleep quality by asking questions on the scale
次要结局
- Changes in the level of IL-6(Preoperative, 6 am on the first day after surgery, 6 am on the third day after surgery)
- Changes in the level of Oxygen saturation(Baseline (Before induction), immediately before intubation, immediately after intubation, at the beginning of the operation, 1 hour after the beginning of the operation, and immediately after extubation at the end of the operation)
- Changes in the level of IL-1(Preoperative, 6 am on the first day after surgery, 6 am on the third day after surgery)
- Changes in the level of Systolic Blood Pressure/Diastolic Blood Pressure(Mean Arterial Pressure)(Baseline (Before induction), immediately before intubation, immediately after intubation, at the beginning of the operation, 1 hour after the beginning of the operation, and immediately after extubation at the end of the operation)
- Changes in the level of Melatonin(Preoperative, 6 am on the first day after surgery, 6 am on the third day after surgery)
- Local cerebral Oxygen Saturation(Collected every 15 minutes before induction of anesthesia to 1 hour after the end of anesthesia)
- Changes in the level of Heart Rate(Baseline (Before induction), immediately before intubation, immediately after intubation, at the beginning of the operation, 1 hour after the beginning of the operation, and immediately after extubation at the end of the operation)
- Changes in the level of IL-10(Preoperative, 6 am on the first day after surgery, 6 am on the third day after surgery)
- Changes in the value and waveform of Narcotrend(Baseline (Before induction), immediately before intubation, immediately after intubation, at the beginning of the operation, 1 hour after the beginning of the operation, and immediately after extubation at the end of the operation)
- Changes in the level of S100-β(Preoperative, 6 am on the first day after surgery, 6 am on the third day after surgery)
研究者
Zhuan Zhang
Director
Yangzhou University