Intranasal Insulin Improves Postoperative Neurocognitive Disorders in Elderly Patients
- Conditions
- Postoperative Neurocognitive Disorders
- Interventions
- Drug: Intranasal saline
- Registration Number
- NCT05613491
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 438
- 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;
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Saline group Intranasal saline Before anesthesia induction, give the equal volumes'saline nasal spray, once per hour, 20 IU each time, until the end of the operation Intranasal insulin group Intranasal insulin Before anesthesia induction, give the first insulin nasal spray, once per hour, 20 IU each time, until the end of the operation
- Primary Outcome Measures
Name Time Method Incidence of postoperative delirium 0-7 days after surgery Whether or not postoperative delirium happens
- Secondary Outcome Measures
Name Time Method Incidence of neurocognitive disorders within 1 year after surgery 30 day-1 year after surgery Whether or not neurocognitive disorders happens
The PND Incidence 0 day-1 year after surgery Whether or not postoperative neurocognitive disorders happensevents after surgery
Intraoperative electroencephalogram parameters Surgery day The intraoperative parameters recorded by electroencephalogram, including BIS occurrence time, the duration with PSI less than 25, spectrum analysis, power spectrum analysis.
ApoE-ε4 susceptibility 1 day before surgery Whether or not carry ApoE-ε4
the level of Neurocognitive biomarkers 0 day-1 year after surgery Neurocognitive biomarkers includes amyloid-beta protein and tau protein.
Incidence of delayed neurocognitive recovery within 30 days after surgery 0-30 days after surgery Whether or not delayed neurocognitive recovery happens
Trial Locations
- Locations (1)
First Affiliated Hospital of Xian Jiaotong University
🇨🇳Xi'an, Shannxi, China