Impact of Sevoflurane Versus Propofol on Postoperative Delirium in Elderly Diabetic Patients Undergoing Non-Cardiac Surgery: a Multicenter, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 450
- 试验地点
- 2
- 主要终点
- the incidence of delirium
研究概览
简要总结
The present study is a multicenter， randomized controlled clinical trial, which plans to enroll 450 diabetic patients aged more than 60 years. The participants will be randomly assigned in a 1:1 ratio and will receive either propofol or sevoflurane for intraoperative anesthesia maintenance to evaluate the impact of these two anesthetic drugs on postoperative delirium. The aim of our study is to explore whether the use of propofol for anesthesia maintenance in elderly diabetic patients undergoing elective non-cardiac major surgery can reduce the incidence of postoperative delirium. This study will provide new perspectives for improving perioperative management in elderly diabetic patients and optimizing anesthesia management strategies to reduce the risk 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
- None (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥60 years
- •Elective surgery (with an expected duration of 2 hours or more)
- •ASA grade Ⅰ-Ⅲ
- •Voluntary participation and informed consent obtained
- •Diabetes mellitus
排除标准
- •Pre-operative BMI≥35 kg/m² (Class II obesity or above)
- •Severe hepatic dysfunction (Child-Pugh class C) or pre-operative dialysis-dependent renal dysfunction
- •Known neurological or psychiatric diseases (Parkinson's disease, depression, schizophrenia), or cognitive impairment (dementia)
- •Severe visual or auditory impairments, language barriers, or patients who cannot cooperate
- •Long-term use of sedatives, antipsychotic drugs, or long-term alcohol abuse
- •Neurosurgical patients
- •Patients with a known allergy to the drugs used in this study or those suspected of having propofol infusion syndrome
研究组 & 干预措施
TIVA
Participants assigned to the TIVA group will receive propofol combined with remifentanil for anesthesia maintenance during the surgery
干预措施: TIVA ( anesthesia with propofol and remifentanil) (Drug)
VA
Participants assigned to the VA group will receive sevoflurane combined with remifentanil for anesthesia maintenance during the surgery.
干预措施: VA（anesthesia with sevoflurane and remifentanil） (Drug)
结局指标
主要结局
the incidence of delirium
时间窗: within the first 7 postoperative days
Postoperative delirium will be assessed daily at 8:00 AM and 6:00 PM from postoperative days 1 to 7, or until discharge, using the 3D-CAM scale.
次要结局
- The duration of POD(within the first 7 postoperative days)
- The length of hospital stay(the first 7 postoperative days)
- The severity of POD(within the first 7 postoperative days)
- The severity of POD(within the first 7 postoperative days)
- The duration of POD(within the first 7 postoperative days)
- The length of hospital stay(the first 7 postoperative days)
- Blood glucose levels(before anesthesia induction (T0), 1 h and 2 h after incision (T1, T2), at skin closure (T3), before PACU discharge (T4), and on post-operative days 1 and 2 (T5, T6))