The Preventive Effect of Different Doses of Intranasal Insulin on Postoperative Delirium

Jilin University

Status: Completed

Conditions: Postoperative Delirium

Treatments: Drug: Intranasal insulin-20U; Drug: Intranasal normal saline; Drug: Intranasal insulin-40U

Study type: Interventional

Funder types: Other

Identifiers

NCT06443957

23K214-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 129 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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129 participants in 3 patient groups, including a placebo group

Intranasal normal saline

Placebo Comparator group

Description:

The patient was given 1ml of normal saline intranasally at 19:00 on the first day of surgery, 50 minutes before anesthesia on the day of surgery, and 19:00 on the day of surgery.

Treatment:

Drug: Intranasal normal saline

Intranasal insulin-20U

Experimental group

Description:

The patient was given 1ml of 20U insulin intranasally at 19:00 on the first day of surgery, 50 minutes before anesthesia on the day of surgery, and 19:00 on the day of surgery.

Treatment:

Drug: Intranasal insulin-20U

Intranasal insulin-40U

Experimental group

Description:

The patient was given 1ml of 40U insulin intranasally at 19:00 on the first day of surgery, 50 minutes before anesthesia on the day of surgery, and 19:00 on the day of surgery.

Treatment:

Drug: Intranasal insulin-40U