A Study on the Correlation Between the Level of Neurofilament Light Chain Protein and the Sensitivity to Remazolam in Older Adults
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- neurofilament light chain protein
研究概览
简要总结
With the acceleration of population aging, China has entered a stage of "deep aging." According to data from the Seventh National Census of Population released in 2021, the proportion of individuals aged 60 or older is 18.70%, with a total number of 264 million, while the proportion of individuals aged 65 or older is 13.50%, with a total number of approximately 190 million. As the proportion of elderly individuals continues to rise, the number of elderly patients undergoing surgical procedures has also increased significantly. Elderly individuals often suffer from multiple chronic diseases, a decline in physiological reserve function, and a reduced tolerance to anesthesia and surgery, presenting new challenges for anesthesiologists. Moreover, cognitive dysfunction is prevalent among the elderly and increases with age . Cognitive dysfunction before surgery is not only closely related to postoperative complications, delirium, further deterioration of cognitive function, and increased mortality, but also leads to longer hospital stays and higher medical expenses after surgery.Therefore, it is of great significance to timely and accurately identify whether the cognitive function of the elderly has been impaired and to actively implement targeted intervention strategies to maintain the health and prognosis of elderly surgical patients, as well as to control the social medical costs.
详细描述
1.1) To investigate the correlation between the levels of neurofilament light chain protein and the scores obtained from the Mini-Mental State Examination (MMSE).
2) Investigate the correlation between the levels of neurofilament light chain protein and the sensitivity to remazolam in elderly patients.
3) Study the factors that influence the sensitivity of remazolane in elderly patients.
2.Methods: One hundred and twenty-eight patients undergoing knee joint replacement were divided into normal cognitive group and cognitive decline group according to MMSE score.
3.MAIN OUTCOME MEASURES: (1) Age, gender, education level, BMI, ASA classification, smoking history, drinking history, cardiovascular disease history, diabetes mellitus history, hyperlipidemia history and COPD history. (2) BP, MAP, HR, degree of saturation of blood oxygen and BIS were measured after entering the room, after the level of spinal anesthesia was stable, when the patient lost consciousness (mascara reflex was lost) after the patient was injected with Rimazolam, and when the patient woke up immediately after the patient stopped taking the drug. (3) The time of consciousness loss (loss of eyelashes reflection) after the injection of rumazine, and the amount of drug injection. (4) How long the patient wakes after stopping the medication. (5) MMSE scores of patients. (6) Take 2 ml cerebrospinal fluid to measure NFL level.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elective knee joint replacements.
- •Age ≥ 60 years.
- •ASA rating I ~ III.
排除标准
- •Persons who have recently used sedatives or opioids.
- •Persons who are allergic to narcotic drugs.
- •People with clotting disorder, infection at the site of the puncture, spinal deformities or spinal disorders.
- •Those who have been diagnosed with nervous system disorders.
- •Patients or family members refuse to participate in this study.
- •Exit research for their own reasons.
研究组 & 干预措施
Group with normal cognitive function
MMSE scores tweney-seven or more points
干预措施: Remazolane (Drug)
Group with declining cognitive function
MMSE scores zero to twenty-seven
干预措施: Remazolane (Drug)
结局指标
主要结局
neurofilament light chain protein
时间窗: 24 hours
Differences in level of neurofilament light chain protein
Loss of consciousness time
时间窗: 24hours
Differences in loss of consciousness time
awakening time
时间窗: 24 hours
Differences in awakening time
Remazolane dosage
时间窗: 24 hours
Differences in Remazolane dosage
Mean Arterial Pressure (MAP)
时间窗: 24 hours
Differences in Mean Arterial Pressure (MAP)
heart rate
时间窗: 24 hours
Differences in heart rate
Electroencephalographic dual frequency index (BIS value)
时间窗: 24 hours
Differences in Electroencephalographic dual frequency index (BIS value)
Incidence of adverse effects (hypotension, bradycardia, respiratory depression)
时间窗: 24 hours
Incidence of adverse effects (hypotension, bradycardia, respiratory depression)
次要结局
- Use of vasoactive drugs(24 hours)
研究者
Zheng Guo
professor
Second Hospital of Shanxi Medical University