drugset / Trial / NCT06443957
The Preventive Effect of Different Doses of Intranasal Insulin on Postoperative Delirium
RandomizedParallel-groupDouble-blindPrevention
Summary
Postoperative delirium is one of the common complications in the older aldults after surgery, which can lead to longer hospita stay,memory loss and reduced quality of life. There is currently no specific treatment. Therefore, it is important to prevent the occurrence of postoperative delirium. This study investigated the effect of intranasal insulin administration on the prevention of postoperative delirium and compared different doses of insulin to find a safe and acceptable method for preventing delirium.
Timeline
- Start
- 2023-07-29
- Primary completion
- 2024-04-13
- Completion
- 2024-04-13
Publications
- Results Marcantonio ER. Delirium in Hospitalized Older Adults. N Engl J Med. 2017 Oct 12;377(15):1456-1466. doi: 10.1056/NEJMcp1605501.
- Results Oh ES, Fong TG, Hshieh TT, Inouye SK. Delirium in Older Persons: Advances in Diagnosis and Treatment. JAMA. 2017 Sep 26;318(12):1161-1174. doi: 10.1001/jama.2017.12067.
- Results Craft S, Raman R, Chow TW, Rafii MS, Sun CK, Rissman RA, Donohue MC, Brewer JB, Jenkins C, Harless K, Gessert D, Aisen PS. Safety, Efficacy, and Feasibility of Intranasal Insulin for the Treatment of Mild Cognitive Impairment and Alzheimer Disease Dementia: A Randomized Clinical Trial. JAMA Neurol. 2020 Sep 1;77(9):1099-1109. doi: 10.1001/jamaneurol.2020.1840.
- Results Huang Q, Li Q, Qin F, Yuan L, Lu Z, Nie H, Gong G. Repeated Preoperative Intranasal Administration of Insulin Decreases the Incidence of Postoperative Delirium in Elderly Patients Undergoing Laparoscopic Radical Gastrointestinal Surgery: A Randomized, Placebo-Controlled, Double-Blinded Clinical Study. Am J Geriatr Psychiatry. 2021 Dec;29(12):1202-1211. doi: 10.1016/j.jagp.2021.02.043. Epub 2021 Feb 23.
- Li Y, Zhang Y, Ren Y, Liu H. Optimal Dose of Intranasal Insulin Administration for Reducing Postoperative Delirium Incidence in Older Patients Undergoing Hip Fracture Surgery. Am J Geriatr Psychiatry. 2025 Aug;33(8):891-900. doi: 10.1016/j.jagp.2025.03.009. Epub 2025 Mar 21.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Insulin | Protein / enzyme biologic | 20 iu | Intranasal |
| Subject | Insulin | Protein / enzyme biologic | 40 iu | Intranasal |