Clinical trial NCT06443957: The Preventive Effect of Different Doses of Intranasal Insulin on Postoperative Delirium
Official title: The Preventive Effect and Safety of Different Doses of Insulin Nasal Administration on Postoperative Delirium in Elderly Hip Fracture Patients - a Randomized, Single Blind, Parallel Controlled, Single Center Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Delirium
Keywords: Postoperative delirium
Insulin
Intranasal administration
Lead sponsor: The First Hospital of Jilin University
Sponsor class: OTHER
First posted: 2024-06-05
Enrollment: 129
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed description: Hip fractures are a common trauma in older adults and occur mainly in older people with osteoporosis. Surgery is the preferred choice for the vast majority of patients with severe pain and limited mobility in older aldults with hip fractures, resulting in higher mortality and disability rates with conservative treatment. But postoperative delirium becomes a challenge. At present, the treatment of delirium includes pharmacological and non-pharmacological methods, but the effect is limited, and now the focus is on preventing delirium, so this study investigated the effect of intranasal insulin administration on the prevention of postoperative delirium.

Eligibility criteria: Inclusion Criteria:

Patients with hip fracture scheduled for unilateral hip arthroplasty or intramedullary nailing under subarachnoid block.

Both genders. Age ≥65 years old. Body mass index (BMI) ≤24kg/m2. American Society of Anesthesiologists (ASA) grade I-III.

Exclusion Criteria:

Contraindications to nasal administration (nasal defects or lesions). History of insulin allergy. Inability to communicate preoperatively (coma, severe visual or hearing impairment).

History of severe heart,Liver and kidney disease. History of psychiatric disorders. Preoperative delirium. Multiple traumas or fractures. Contraindications to subarachnoid block.

Primary outcomes:
measure: postoperative delirium
timeFrame: From 18:00 to 19:00 on the 1st postoperative day, the 2nd postoperative day, and the 3rd postoperative day,
Secondary outcomes:
measure: visual analogue scale
timeFrame: On the 1st postoperative day, the 2nd postoperative day, and the 3rd postoperative day,
measure: Lactate content in cerebrospinal fluid
timeFrame: During the anesthesia
measure: Blood glucose values
timeFrame: 1 day before the operation, 40 minutes after nasal administration of insulin or normal saline, before surgery and immediately after surgery
measure: Glucose content in cerebrospinal fluid
timeFrame: During the anesthesia
Other outcomes:
Locations:
city: Changchun
country: China
facility: The first hospital of Jilin University
Study officials:
References:
citation: Marcantonio ER. Delirium in Hospitalized Older Adults. N Engl J Med. 2017 Oct 12;377(15):1456-1466. doi: 10.1056/NEJMcp1605501.
citation: 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.
citation: 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.
citation: 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.