Intranasal Insulin Improves Postoperative Neurocognitive Disorders in Elderly Patients: a Multicenter, Randomized, Double-blind, Placebo-controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 438
- 试验地点
- 1
- 主要终点
- Incidence of postoperative delirium
研究概览
简要总结
Postoperative neurocognitive disorders (PND) are common postoperative complication of central nervous system, leading to increased risk of the working ability loss after surgery, longer hospital stay, increased medical costs and increased surgical mortality. It is classified as perioperative neurocognitive disorders in mental disorders.Aging is an important demographic characteristic in China, and the elderly is also a population susceptible to PND. There is a lack of targeted prevention and control measures for PND. Central insulin resistance is an important mechanism of cognitive impairment in elderly patients, and exogenous supply of central insulin may be an important measure to improve PND. Compared with conventional subcutaneous and intravenous supply, intranasal insulin administration not only has little effect on blood glucose and insulin levels, but also enters the center through the blood-brain barrier easily and efficiently. Long-term use of intranasal insulin can improve the cognitive function of chronic diseases, but there is a lack of clinical studies on improving PND by intranasal insulin. This study will verify the effectiveness of intranasal insulin in the PND improvement of elderly patients.
详细描述
This study is intended to carry out a large sample, multicenter, double-blind, randomized, placebo, and controlled clinical study. Elderly non diabetes patients undergoing elective extrathoracic, breast, orthopedic, urinary, abdominal, and gynecological operations under general anesthesia are included. They are randomly divided into intranasal insulin group or saline group. Before anesthesia induction, they are given the first nasal spray, once per hour, 20 IU insulin or equal volume saline each time until the end of the operation. Follow up 1 day before operation, 1-7 days after operation, 30 days and 12 months respectively, and evaluate cognition with relevant scales. To verify that compared with the same volume of saline, intranasal insulin can reduce the incidence of postoperative delirium, the incidence of PND 1 year after surgery, and the related cognitive quantitative indicators of ApoE- ɛ4 Gene susceptibility, intraoperative EEG parameters, NfL, IL-6, IL-10, CRP and other biochemical indicators were used to explore the mechanism of intranasal insulin to improve PND.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 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
- •Patients under general anesthesia through oral intubation;
- •Patients undergoing elective extrathoracic, breast, orthopaedic, urological, abdominal and gynecological operations;
- •Age ≥ 65 years;
- •Cardiac function grade I~II (NYHA standard), ASA grade I~III;
- •Volunteer for anticipating study and sign an informed consent form;
排除标准
- •Diabetes patients;
- •Previous history of craniocerebral and spinal cord trauma, surgery, stroke, and inability to place electrodes on the head;
- •History of nasal cavity stuffiness, epistaxis, rhinitis, and nasopharynx surgery; The operation position is prone and it is difficult to implement intranasal administration;
- •Those who cannot cooperate with the assessment of the scale or have delirium before operation;
- •Preoperative fasting blood glucose<4 mmol/L;
- •Those who have participated in other clinical trials.
研究组 & 干预措施
Intranasal insulin group
Before anesthesia induction, give the first insulin nasal spray, once per hour, 20 IU each time, until the end of the operation
干预措施: Intranasal insulin (Drug)
Saline group
Before anesthesia induction, give the equal volumes'saline nasal spray, once per hour, 20 IU each time, until the end of the operation
干预措施: Intranasal saline (Drug)
结局指标
主要结局
Incidence of postoperative delirium
时间窗: 0-7 days after surgery
Whether or not postoperative delirium happens
次要结局
- Incidence of neurocognitive disorders within 1 year after surgery(30 day-1 year after surgery)
- The PND Incidence(0 day-1 year after surgery)
- Intraoperative electroencephalogram parameters(Surgery day)
- ApoE-ε4 susceptibility(1 day before surgery)
- the level of Neurocognitive biomarkers(0 day-1 year after surgery)
- Incidence of delayed neurocognitive recovery within 30 days after surgery(0-30 days after surgery)