Postoperative Neurocognitive Disorders
Conditions
Keywords
postoperative neurocognitive disorders, Intranasal insulin
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.
Interventions
DRUGIntranasal insulin
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
Sponsors
Tang-Du Hospital
Tongji Hospital
Second Hospital of Shanxi Medical University
LanZhou University
Sichuan Provincial People's Hospital
The First Affiliated Hospital of Zhengzhou University
521 Hospital of NORINCO Group
First Affiliated Hospital Xi'an Jiaotong University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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;
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of postoperative delirium | 0-7 days after surgery | Whether or not postoperative delirium happens |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| the level of Neurocognitive biomarkers | 0 day-1 year after surgery | Neurocognitive biomarkers includes amyloid-beta protein and tau protein. |
| The PND Incidence | 0 day-1 year after surgery | Whether or not postoperative neurocognitive disorders happensevents after surgery |
| Incidence of delayed neurocognitive recovery within 30 days after surgery | 0-30 days after surgery | Whether or not delayed neurocognitive recovery happens |
| Incidence of neurocognitive disorders within 1 year after surgery | 30 day-1 year after surgery | Whether or not neurocognitive disorders happens |
| ApoE-ε4 susceptibility | 1 day before surgery | Whether or not carry ApoE-ε4 |
Countries
China
Contacts
Primary ContactQiang Wang, MD,PHD
Outcome results
None listed