The Preventive Effect of Different Doses of Intranasal Insulin on Postoperative Delirium
- Conditions
- Postoperative Delirium
- Interventions
- Drug: Intranasal normal salineDrug: Intranasal insulin-20UDrug: Intranasal insulin-40U
- Registration Number
- NCT06443957
- Lead Sponsor
- The First Hospital of Jilin University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 129
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.
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intranasal normal saline Intranasal normal saline 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. Intranasal insulin-20U Intranasal insulin-20U 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. Intranasal insulin-40U Intranasal insulin-40U 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.
- Primary Outcome Measures
Name Time Method postoperative delirium From 18:00 to 19:00 on the 1st postoperative day, the 2nd postoperative day, and the 3rd postoperative day, The CAM-ICU scale is used to evaluate whether postoperative delirium occurs in three groups of patients. The scale is divided into four parts: acute changes and fluctuations in consciousness state, attention disorders, changes in consciousness level, and cognitive confusion. If acute changes in consciousness and attention deficit occur simultaneously, combined with changes in consciousness level and cognitive confusion, either can be diagnosed as postoperative delirium.
- Secondary Outcome Measures
Name Time Method visual analogue scale On the 1st postoperative day, the 2nd postoperative day, and the 3rd postoperative day, Assess postoperative pain，0 represents painless, 10 represents severe pain, and the higher the score, the more severe the pain will be.
Lactate content in cerebrospinal fluid During the anesthesia The patient underwent neuraxial anesthesia to obtain 0.5ml of cerebrospinal fluid and measure the lactate content in the cerebrospinal fluid
Blood glucose values 1 day before the operation, 40 minutes after nasal administration of insulin or normal saline, before surgery and immediately after surgery A blood glucose meter is used to measure the patient's fingerstick blood glucose
Glucose content in cerebrospinal fluid During the anesthesia The patient underwent neuraxial anesthesia to obtain 0.5ml of cerebrospinal fluid and measure the glucose content in the cerebrospinal fluid
Trial Locations
- Locations (1)
The first hospital of Jilin University
🇨🇳Changchun, China