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The effect of intranasal insulin on preventing perioperative neurocognitive disorders in elderly patients: a prospective, double-blind, randomized controlled trial

The effect of intranasal insulin on preventing perioperative neurocognitive disorders in elderly patients: a prospective, double-blind, randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500110501
Enrollment
Unknown
Registered
2025-10-14
Start date
2025-10-20
Completion date
Unknown
Last updated
2025-10-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Perioperative Neurocognitive Disorders

Interventions

Insulin nasal drop group (Group I): Each patient in Group I will receive intranasal ASP-I (40 IU per dose, prepared by diluting 0.4 ml of ASP-I with an equal volume of saline to a total volume of 0.8
Placebo control group (P group):Each patient in Group P will receive same volume of saline, with all other procedures identical to those in Group I

Sponsors

The Affiliated Hospital of Qingdao University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Intended for elderly patients aged >=60 undergoing non-cardiac surgery under general anesthesia, including patients undergoing general anesthesia for gastrointestinal surgery, thoracic surgery, urological surgery, orthopedic surgery, gynecological surgery, etc.; 2. Signing the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Contraindications for intranasal administration (such as nasal defects or lesions); 2. History of insulin allergy; 3. Severe communication disorders (such as coma, severe dementia, speech disorders, severe visual or hearing impairments, etc.); 4. Presence of severe heart, liver, or kidney diseases (such as severe arrhythmia, symptomatic coronary artery disease, myocardial ischemia/infarction, heart failure [NYHA III-IV], liver dysfunction [Child-Pugh B/C], or renal dysfunction [eGFR <30 mL/min/1.73m^2]); 5. History of mental illness; 6. Individuals with significant cooperation difficulties (e.g., very low educational level, unable to read or perform basic arithmetic); 7. Diabetic patients; 8. Individuals planning to undergo neurosurgical intracranial procedures;9. History of substance abuse.

Design outcomes

Primary

MeasureTime frame
Postoperative delirium;

Secondary

MeasureTime frame
Postoperative acute delirium/agitation;Duration of POD;Delayed neurocognitive recovery;Postoperative neurocognitive disorders;Instrumental activities of daily living (ADLs);Sleep quality;

Countries

China

Contacts

Public ContactZhang Lei

The Affiliated Hospital of Qingdao University

qdfy1099718909@163.com+86 187 1782 2662

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026