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Effect of intranasal insulin pretreatment on postoperative delirium in elderly orthopedic surgery patients with preoperative mild cognitive impairment: a single-center, prospective, double-blind randomized controlled clinical study

Effect of intranasal insulin pretreatment on postoperative delirium in elderly orthopedic surgery patients with preoperative mild cognitive impairment: a single-center, prospective, double-blind randomized controlled clinical study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400089093
Enrollment
Unknown
Registered
2024-09-02
Start date
2024-09-10
Completion date
Unknown
Last updated
2024-09-09

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

Conditions

postoperative delirium

Interventions

Sponsors

The General Hospital of the Western Theater Command
Lead Sponsor

Eligibility

Sex/Gender
All
Age
80 Years to 100 Years

Inclusion criteria

Inclusion criteria: The subjects must meet the following conditions: (1) Patients who are scheduled to undergo orthopedic surgery; (2) Age 80 to 100 years old; (3) The American Society of Anesthesiologists grades I to III; (4) BMI between 18-25kg/m2; (5) No contraindications for general anesthesia; (6) Preoperative self description and family statement of subjective memory decline, with a score of 15-24 on the Beijing version of the Montreal Scale (MoCA); (7) The Mini Mental State Scale (MMSE) score is = 27 points, and (8) the Clinical Dementia Rating Scale (CDR) is 0 5 points; (9) The daily living ability scale (ADL) score is = 26 points.

Exclusion criteria

Exclusion criteria: (1) Preoperative neurological disorders that affect cognitive function (such as vascular dementia); (2) Severe liver and kidney dysfunction (ALT or AST exceeding the upper limit of normal by 1.5 times, creatinine or urea nitrogen exceeding the upper limit of normal); (3) Severe respiratory system diseases; (4) Severe cardiovascular disease; (5) Recently taking sedatives or antidepressants; (6) Taboos for nasal administration; (7) Individuals who are allergic to insulin; (8) Administer insulin to patients through other means.

Design outcomes

Primary

MeasureTime frame
POD incidence rate;

Secondary

MeasureTime frame
Extracellular regulated protein kinases;cAMP-response element binding protein;Brain-derived neurotrophic factor;

Countries

China

Contacts

Public ContactHuang Qingqing

The General Hospital of the Western Theater Command

970327481@qq.com+86 152 8301 7764

Outcome results

None listed

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