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
研究组 & 干预措施
acupuncture group
In the acupuncture group, acupoints of Baihui, Shenting, Sishencong will be selected for acupuncture stimulation be anesthesia. The needle will be kept for 30 minutes, during which the needle will be performed once every 10 minutes for 10 seconds each time, 4 times in total. The therapist will give the subject verbal cues before and during the needle manipulation.
干预措施: acupuncture (Device)
placebo acupuncture group
The patients will be treated with consolation needle. Choose treatment of points that near but without going through the acupoints(upper arm deltoid muscle). Use the Park needle (blunt needle, tip obtuse, when acupuncture the feeling is similar to acupuncture needles into the skin, but it retracts instead of piercing the skin) to conduct acupuncture treatment. The retention time and number of needles will be the same as those in the acupuncture group. The therapist will give the subjects verbal cues before and during the acupuncture manipulation, which further reduces the subjects' doubts about the authenticity of acupuncture in the this group. To ensure the implementation of the blinding method, all patients will be treated independently and avoid contacting with each other.
干预措施: placebo acupuncture (Device)
control group
The patients will undergoing routine anesthesia without acupuncture treatment.
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
Incidence of postoperative delirium
时间窗: at 8 a.m. the day after surgery
assess the incidence of postoperative delirium using the 3-minute diagnostic confusion assessment method (3D-CAM)
Incidence of postoperative delirium
时间窗: at 16 p.m. the day after surgery
assess the incidence of postoperative delirium using 3D-CAM
Incidence of postoperative delirium
时间窗: at 8 a.m. the second day after surgery
assess the incidence of postoperative delirium using 3D-CAM
Incidence of postoperative delirium
时间窗: at 16 p.m. the second day after surgery
assess the incidence of postoperative delirium using 3D-CAM
Incidence of postoperative delirium
时间窗: at 8 a.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)
- Regional Saturation of Oxygenation (rSO2)(baseline)
- Regional Saturation of Oxygenation (rSO2)(the time when tracheal intubation finished)
- Regional Saturation of Oxygenation (rSO2)(the time when the surgery begins)
- Regional Saturation of Oxygenation (rSO2)(1 hour after the beginning of the surgery)
- Regional Saturation of Oxygenation (rSO2)(the time when the surgery ends)
研究者
Lingling Ding
Professor
Beijing Hospital of Traditional Chinese Medicine