Intranasal Insulin for Prevention of Postoperative Delirium in Older Patients With Type 2 Diabetes: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 210
- 主要终点
- Postoperative Delirium
研究概览
简要总结
Postoperative delirium (POD) is highly prevalent in older patients with type 2 diabetes mellitus (T2DM). Cerebral insulin resistance is considered a key pathophysiological mechanism underlying this association. This study aims to investigate whether intranasal insulin (INI) can prevent POD and early postoperative cognitive decline by improving cerebral insulin resistance. We will conduct a randomized, double-blind, placebo-controlled multicenter trial. Older T2DM patients will be randomly assigned to receive intranasal insulin at doses of 40 IU or 80 IU, or placebo. The primary objective is to evaluate the efficacy of INI in preventing POD and to determine the dose-response relationship.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of type 2 diabetes mellitus (T2DM) according to the World Health Organization (WHO) criteria.
- •Age ≥ 65 years.
- •Scheduled for elective hepatobiliary tumor resection with an anticipated surgical duration of ≥ 2 hours.
- •Voluntary provision of written informed consent by the patient or their legally authorized representative.
排除标准
- •Preoperative diagnosis of dementia, or an education-adjusted Mini-Mental State Examination (MMSE) score indicating cognitive impairment (illiteracy < 17, primary education < 20, secondary education or above < 24).
- •Severe visual, auditory, or language impairments precluding the completion of neurocognitive assessments.
- •American Society of Anesthesiologists (ASA) physical status classification ≥ IV.
- •History of severe central nervous system disorders (e.g., Parkinson's disease, stroke within the past 6 months, severe traumatic brain injury) or schizophrenia; or chronic use of antipsychotic or antidepressant medications.
- •Nasal anatomical abnormalities or pathologies that may compromise intranasal drug absorption (e.g., severe allergic rhinitis, severe deviated septum, recent nasal trauma or surgery, nasal polyps).
- •Known hypersensitivity to insulin or any of its excipients.
- •Extremely poor glycemic control (e.g., HbA1c > 10%), or an episode of severe hypoglycemia or diabetic ketoacidosis within the 3 months prior to enrollment.
结局指标
主要结局
Postoperative Delirium
时间窗: Postoperative Day 1 to Postoperative Day 7
The occurrence of postoperative delirium will be assessed using the 3D-CAM (3-Minute Diagnostic Interview for CAM). Assessments will be conducted twice daily (at 09:00-10:00 and 16:00-17:00) from postoperative day 1 through postoperative day 7.
次要结局
- Postoperative Mild Cognitive Impairment (MCI)(Postoperative Day 7, 1 Month, and 6 Months)
- Postoperative Short-term Memory Impairment(Postoperative Day 7, 1 Month, and 6 Months)
研究者
Weidong Mi
Professor and Chairman, Department of Anesthesiology
Chinese PLA General Hospital