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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
QUADRUPLE
Enrollment
438
Put insulin injection into nasal special drug delivery device.Before anesthesia induction, give the first insulin nasal spray, once per hour, 20 IU each time, until the end of the operation
Put 0.9% sodium chloride into nasal special drug delivery device.Before anesthesia induction, give the first equal volume saline nasal spray, once per hour, 20 IU each time, until the end of the operation
First Affiliated Hospital of Xian Jiaotong University
Xi'an, Shannxi, China
RECRUITINGIncidence of postoperative delirium
Whether or not postoperative delirium happens
Time frame: 0-7 days after surgery
Incidence of delayed neurocognitive recovery within 30 days after surgery
Whether or not delayed neurocognitive recovery happens
Time frame: 0-30 days after surgery
Incidence of neurocognitive disorders within 1 year after surgery
Whether or not neurocognitive disorders happens
Time frame: 30 day-1 year after surgery
The PND Incidence
Whether or not postoperative neurocognitive disorders happensevents after surgery
Time frame: 0 day-1 year after surgery
Intraoperative electroencephalogram parameters
The intraoperative parameters recorded by electroencephalogram, including BIS occurrence time, the duration with PSI less than 25, spectrum analysis, power spectrum analysis.
Time frame: Surgery day
the level of Neurocognitive biomarkers
Neurocognitive biomarkers includes amyloid-beta protein and tau protein.
Time frame: 0 day-1 year after surgery
ApoE-ε4 susceptibility
Whether or not carry ApoE-ε4
Time frame: 1 day before surgery
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.