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Intranasal Insulin Improves Postoperative Neurocognitive Disorders in Elderly Patients

Sponsor
First Affiliated Hospital Xi'an Jiaotong University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05613491
Collaborator
Tang-Du Hospital (Other), Tongji Hospital (Other), Second Hospital of Shanxi Medical University (Other), LanZhou University (Other), Sichuan Provincial People's Hospital (Other), The First Affiliated Hospital of Zhengzhou University (Other), 521 Hospital of NORINCO Group (Other)
438
Enrollment
1
Location
2
Arms
9.8
Anticipated Duration (Months)
44.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Intranasal insulin
  • Drug: Intranasal saline
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
438 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Health Services Research
Official Title:
Intranasal Insulin Improves Postoperative Neurocognitive Disorders in Elderly Patients: a Multicenter, Randomized, Double-blind, Placebo-controlled Study
Actual Study Start Date :
Nov 7, 2022
Anticipated Primary Completion Date :
Jul 31, 2023
Anticipated Study Completion Date :
Aug 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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

Drug: Intranasal 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
Other Names:
  • Insulin injection，H10890001,Jiangsu Wanbang Biochemical Medicine Group Co., Ltd

    		•
    Placebo Comparator: 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

    Drug: Intranasal saline
    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
    Other Names:
  • 0.9% sodium chloride，H20013250,Shanghai Baite Medical Supplies Co., Ltd

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of postoperative delirium [0-7 days after surgery]

      Whether or not postoperative delirium happens

    Secondary Outcome Measures

    1. Incidence of delayed neurocognitive recovery within 30 days after surgery [0-30 days after surgery]

      Whether or not delayed neurocognitive recovery happens

    2. Incidence of neurocognitive disorders within 1 year after surgery [30 day-1 year after surgery]

      Whether or not neurocognitive disorders happens

    3. The PND Incidence [0 day-1 year after surgery]

      Whether or not postoperative neurocognitive disorders happensevents after surgery

    4. 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.

    5. the level of Neurocognitive biomarkers [0 day-1 year after surgery]

      Neurocognitive biomarkers includes amyloid-beta protein and tau protein.

    6. ApoE-ε4 susceptibility [1 day before surgery]

      Whether or not carry ApoE-ε4

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    65 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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 III (NYHA standard), ASA grade IIII;

    • 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 First Affiliated Hospital of Xian Jiaotong University Xi'an Shannxi China 029710061

    Sponsors and Collaborators

    • First Affiliated Hospital Xi'an Jiaotong University
    • 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

    Investigators

    • Study Chair: Qiang Wang, MD,PHD, First Affiliated Hospital of Xian JiaotongUniversity

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    First Affiliated Hospital Xi'an Jiaotong University
    ClinicalTrials.gov Identifier:
    NCT05613491
    Other Study ID Numbers:
    • XJTU1AF2022LSK-265
    First Posted:
    Nov 14, 2022
    Last Update Posted:
    Nov 14, 2022
    Last Verified:
    Nov 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by First Affiliated Hospital Xi'an Jiaotong University
    postoperative neurocognitive disorders
    Intranasal insulin
    Additional relevant MeSH terms:
    Disease
    Neurocognitive Disorders
    Insulin
    Insulin, Globin Zinc

    Study Results

    No Results Posted as of Nov 14, 2022