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The effect of intranasal insulin pretreatment on postoperative delirium in patients undergoing knee replacement surgery in high-altitude areas: a single center, prospective, double-blind, randomized, controlled clinical study

The effect of intranasal insulin pretreatment on postoperative delirium in patients undergoing knee replacement surgery in high-altitude areas: a single center, prospective, double-blind, randomized, controlled clinical study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500107937
Enrollment
Unknown
Registered
2025-08-21
Start date
2025-09-01
Completion date
Unknown
Last updated
2025-08-25

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

Conditions

postoperative delirium

Interventions

Sponsors

Ganzi Tibetan Autonomous Prefecture People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. ASAI~III level; 2. Age>=18 years old; 3. Resident residents of plateau areas; 4. Patients who plan to undergo knee replacement under general anesthesia; 5. Operation time 2-5 hours; 6.BMI<=28kg/m² ; 7. Sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients with preoperative delirium; 2. Those with a history of insulin allergy or alcoholism; 3. Inability to communicate before surgery (coma, deep dementia or speech impairment); 4. Patients who are contraindicated to nasal administration (such as nasal defects or lesions); 5. Previous hypertension and diabetes; 6. Mini-mentalState Examination (MMSE) score (illiteracy< 17 points, primary school level <20 points, secondary school level (including technical secondary school) <24 points); 7. Severe cardiovascular and renal function diseases; 8. History of neurological diseases; 9. Preoperative history of schizophrenia, epilepsy, Parkinson's disease, or myasthenia gravis; 10. Severe visual and auditory impairment.

Design outcomes

Primary

MeasureTime frame
POD incidence rate;

Secondary

MeasureTime frame
Long term cognitive function;Pain score;interleukin-6;interleukin-1ß;Tumor Necrosis Factor-a;C-reactive protein;Monocyte chemoattractant protein-1;

Countries

China

Contacts

Public ContactLuo Xiaoqin

Ganzi Tibetan Autonomous Prefecture People's Hospital

1813993044@qq.com+86 139 9046 0756

Outcome results

None listed

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