A Prospective Randomized Controlled Study of Acupuncture on Postoperative Delirium in Patients With Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 215
- 主要终点
- Incidence of postoperative delirium
研究概览
简要总结
- To evaluate the effectiveness and safety of acupuncture on POD in diabetic patients undergoing surgery, to provide effective prevention and treatment measures of integrated traditional Chinese and western medicine for reducing the incidence of postoperative delirium in high-risk groups, and to provide clinical basis for further promotion of integrated traditional Chinese and western medicine anesthesia in the future.
- To investigate the relationship between POD and rSO2 in diabetic patients undergoing surgery. To clarify the predictive value of intraoperative rSO2 monitoring on postoperative cognitive function in patients with diabetes, and to explore the effect of acupuncture on cerebral blood flow perfusion in patients with diabetes.
详细描述
Postoperative delirium (POD) increases the risk of postoperative dementia and mortality. Cognitive decline is common in patients with diabetes mellitus. As an independent risk factor for POD, diabetes significantly increases postoperative dementia and mortality. Our team found that acupuncture can reduce the incidence of POD in elderly patients, increase regional cerebral oxygen saturation (rSO2), and increase cerebral blood flow perfusion in diabetic patients. In this study, a prospective randomized controlled study with placebo acupuncture will be conducted. Diabetic patients undergoing elective surgery will be divided into acupuncture group, placebo acupuncture group and control group. Acupuncture will be used as the intervention method, and the incidence of POD will be the main therapeutic effect evaluation index to explore the efficacy of acupuncture in the prevention and treatment of POD in diabetic patients undergoing surgery.
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
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing general anesthesia in our hospital
- •Expected duration of operation >2h
- •Ages 18-60
- •With type 2 diabetes
- •American Society of Anesthesiologists (ASA) grade 2-3 , no severe respiratory, circulation, liver, kidney, coagulation function abnormalities;
- •Expected postoperative hospital stay >3 days
- •No history of cerebrovascular accident in the past six months
- •The informed consent signed
排除标准
- •Unable or unwilling to cooperate with cognitive function scale tests
- •MMSE score <24
- •Refuse acupuncture treatment or have a history of needle sickness
- •With skin damage at the acupuncture sites
- •Coagulation dysfunction
- •Participated in other clinical studies
结局指标
主要结局
Incidence of postoperative delirium
时间窗: at 16 p.m. the third day after surgery
assess the incidence of postoperative delirium using 3D-CAM
次要结局
- Expression of peroxisome proliferators-activated receptor-γcoactivator-1α (PGC-1α)(Entering the operating room, the time when the surgery ends)
- Blood glucose levels(Entering the operating room, the time when the surgery ends)
- Expression of reactive oxygen species (ROS), superoxide dismutase (SOD), S100β in serum(Entering the operating room, the time when the surgery ends)
- Regional Saturation of Oxygenation (rSO2)(Intraoperative)
- Visual Analogue Score (VAS)(at 8 a.m. and 16 p.m. daily for 3 days after surgery)
研究者
Lingling Ding
Professor
Beijing Hospital of Traditional Chinese Medicine