Randomized Controlled Trial on the Effects of Transcutaneous Electroacupuncture on Brain Functional Connectivity in Postoperative Pain Patients Based on Electroencephalography
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Electroencephalogram analysis
研究概览
简要总结
A total of 90 subjects underwent abdominal surgery under general anesthesia at Chaoyang Hospital in Beijing. The subjects were divided into a percutaneous acupoint electrical stimulation group and a control group. The subjects were selected for TEAS stimulation at the Neiguan, Hegu, and Zusanli acupoints on both sides, and EEG data were collected using a 32 lead EEG cap test throughout the entire process. During the experiment, changes in hemodynamic parameters (blood pressure, heart rate) and perioperative pain scores of the subjects will be recorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 80 years;
- •ASA physical status classification I-II;
- •Scheduled to undergo abdominal surgery under general anesthesia (e.g., gastrectomy, colorectal cancer surgery, etc.);
- •Consent to participate in the study and signing of the informed consent form.
排除标准
- •Impaired cognitive function or language communication disorders;
- •Mental disorders, epilepsy, or abnormal EEG activity;
- •Receipt of acupoint therapy within two weeks prior to surgery;
- •Presence of a cardiac pacemaker or metal implants;
- •Allergy to surface electrodes;
- •Concomitant medical conditions (e.g., dermatological disorders) that may affect treatment or trial administration.
研究组 & 干预措施
Transcutaneous electrical acupoint stimulation group
Group description: Participants in the reorganization will receive TEAS stimulation at bilateral Neiguan, Hegu, and Zusanli acupoints, and EEG data will be collected throughout the entire process using a 32 lead EEG cap test. During the experiment, changes in hemodynamic parameters (blood pressure, heart rate) and perioperative pain scores of the subjects will be recorded.
干预措施: Transcutaneous electrical acupoint stimulation (Device)
Control group
Attach electrodes to the same area but do not apply stimulation, while informing the patient that percutaneous acupoint electrical stimulation therapy has been performed
结局指标
主要结局
Electroencephalogram analysis
时间窗: Five - minute baseline EEG data with eyes closed during wakefulness；EEG data during pre - operative transcutaneous electrical acupoint stimulation；Immediate post - operative EEG data
Changes in EEG in the experimental group with transcutaneous electrical acupoint stimulation compared to the baseline, as well as post - operative EEG changes in the experimental group and the control group.Including：node clustering coefficient，node efficiency，normalized mean clustering coefficient，normalized path length，modularity，small-world network
次要结局
- Patients' VAS score(24 hours after surgery)