The Guiding Significance of Pupil Monitoring in the Perioperative Period
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Changes in the level of Mini-Men-tal State Examination scale score
研究概览
简要总结
The pupil diameter is affected by both sympathetic and parasympathetic nerves, and its latency and response amplitude mainly reflect the functional status of the parasympathetic nerve. Clinically, the diagnosis of neurological diseases can often be made based on changes in pupils.
An appropriate depth of anesthesia can cause minimal damage to the body after surgery, thereby reducing the impact on brain function and cognitive function.
The occurrence of postoperative delirium will have adverse effects on the prognosis of patients, such as prolonging the hospital stay, increasing the mortality of patients after surgery, and increasing early postoperative cognitive dysfunction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 95 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elderly patients undergoing general anesthesia for tracheal intubation, aged ≥65 years, operation time ≥2 hours, ASA classification I-III, and postoperative hospital stay for at least one week.
排除标准
- •It is known that this study involves persons who are allergic to general anesthetics;
- •Patients with previous eye diseases;
- •Head and neck surgery is not conducive to measurement;
- •Patients with preoperative MMSE score less than 24 points or dementia due to various diseases;
- •Patients planning to undergo neurosurgery;
- •Those who use sedatives or antipsychotics before surgery;
- •Patients with known central nervous system diseases, such as mental illness; Patients with hearing or vision impairment and unable to communicate normally.
结局指标
主要结局
Changes in the level of Mini-Men-tal State Examination scale score
时间窗: The day before surgery and 1,2,3,7 days after surgery
Assess the cognitive function of the patient by asking questions on the patient scale.A score of 27 to 30 indicates normal cognitive function, and a score below 27 indicates cognitive dysfunction.
Changes in the level of CAM-ICU scale score
时间窗: 1,2,3,7 days after surgery
First, evaluate the patient's state of consciousness based on the patient's behavior, and decide whether to proceed with the next evaluation based on the state of consciousness. If the next step is to be evaluated, ask the patient related questions to score, and evaluate whether the patient has delirium based on the score.The lower the score, the more likely the patient is to suffer from delirium. questions to score, and evaluate whether the patient has delirium based on the score. with the next evaluation based on the state of consciousness. If the next step is to be evaluated, ask the patient related questions to score, and evaluate whether the patient has delirium based on the score.
Changes in the level of Polysomnography
时间窗: "before surgery", "the time of intubation", the time of extubation", "1min,3min after intubation", "10min,20min, 30min after extubation", "the reflection of light appears""1,2,3,7 day after surgery "
Through the polysomnograph, monitor the patient's sleep during anesthesia, including brain wave changes and sleep stages at different time points
Changes in the level of pupil diameter
时间窗: "before surgery", "the time of intubation", the time of extubation", "1min,3minafter intubation", "10min,20min, 30min after extubation", "the reflection of light appears""1,2,3,7 day after surgery "
Changes in the level of Pittsburgh sleep quality index
时间窗: The day before surgery and 1,2,3,7 days
Assess the patient's sleep quality by asking questions on the scale.The lower the score, the more serious the sleep disorder.
Changes in the level of pupil light reflection
时间窗: "before surgery", "the time of intubation", the time of extubation", "1min,3minafter intubation", "10min,20min, 30min after extubation", "the reflection of light appears""1,2,3,7 day after surgery "
次要结局
- Changes in the level of Heart Rate("before surgery", "the time of intubation", the time of extubation", "1min,3min after intubation", "10min,20min, 30min after extubation", "the reflection of light appears")
- Changes in the level of Systolic Blood Pressure/Diastolic Blood Pressure(Mean Arterial Pressure)("before surgery", "the time of intubation", the time of extubation", "1min,3min after intubation", "10min,20min, 30min after extubation", "the reflection of light appears")
- Changes in the waveform of Narcotrend("before surgery", "the time of intubation", the time of extubation", "1min,3min after intubation", "10min,20min, 30min after extubation", "the reflection of light appears")
- Changes in the level of Oxygen saturation("before surgery", "the time of intubation", the time of extubation", "1min,3min after intubation", "10min,20min, 30min after extubation", "the reflection of light appears")
研究者
Zhuan Zhang
Director
Yangzhou University