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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 129
- 试验地点
- 1
- 主要终点
- postoperative delirium
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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/m
- •American Society of Anesthesiologists (ASA) grade I-III.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Intranasal normal saline (Drug)
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.
干预措施: Intranasal insulin-20U (Drug)
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.
干预措施: Intranasal insulin-40U (Drug)
结局指标
主要结局
postoperative delirium
时间窗: 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.
次要结局
- Lactate content in cerebrospinal fluid(During the anesthesia)
- Glucose content in cerebrospinal fluid(During the anesthesia)
- Blood glucose values(1 day before the operation, 40 minutes after nasal administration of insulin or normal saline, before surgery and immediately after surgery)
- visual analogue scale(On the 1st postoperative day, the 2nd postoperative day, and the 3rd postoperative day,)