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A randomized, controlled study of intranasal insulin preconditioning to reduce postoperative delirium by inhibiting NLRP3/Caspase-1/IL-1ß signaling pathway

A randomized, controlled study of intranasal insulin preconditioning to reduce postoperative delirium by inhibiting NLRP3/Caspase-1/IL-1ß signaling pathway

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200056906
Enrollment
Unknown
Registered
2022-02-22
Start date
2022-02-25
Completion date
Unknown
Last updated
2023-09-18

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

Conditions

Postoperative delirium

Interventions

control group:Saline

Sponsors

The General Hospital of Western Theater Command
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Age =60 years old; 2.ASA grade I~III; 3.BMI=28kg/m2; 4.Planned to undergo radical esophagectomy under general anesthesia; 5.Signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients who are contraindicated to nasal administration (such as nasal cavity defects or lesions); 2. Have hypertension and diabetes in the past; Have a history of insulin allergy; Have a history of alcoholism; 3. Unable to communicate before operation (coma, deep dementia or language disorder, severe visual and hearing impairment); 4. The MMSE score is too low [illiteracy<17 points, primary school level<20 points, secondary school level (including technical secondary school)<24 points]; 5. Severe heart, liver and kidney disease; 6. History of nervous system disease or mental disease; 7. Withdrawal criteria: insulin was used by other means than nasal route during the test; 8. Perform operation again within 3 days after operation; 9. Unexpected adverse events (such as drug allergy, anesthesia and surgical accidents); 10. The patient lost the follow-up.

Design outcomes

Primary

MeasureTime frame
Total incidence of POD in 3 days;NLRP3 mRNA;Casepase-1mRNA;IL-1ß;

Secondary

MeasureTime frame
age;gender;body mass index;Educational level;Operation time;ASA classification;Preoperative hemoglobin concentration;Preoperative hemoglobin concentration;Intraoperative blood loss;Intraoperative blood transfusion;NRSIscale;Serum insulin concentration;

Countries

China

Contacts

Public ContactHuang Qingqing

the General Hospital Of Western Theater Command

970327481@qq.com+86 15283017764

Outcome results

None listed

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