The Effect of Transcutaneous Electrical Acupoint Stimulation Combined With Transcutaneous Auricular Vagus Nerve Stimulation on Postoperative Delirium in Elderly Patients Undergoing Gastrointestinal Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- Incidence of postoperative delirium
研究概览
简要总结
The aim of this clinical trial is to study the effect of transcutaneous electrical acupoint stimulation combined with auricular vagus nerve stimulation on postoperative delirium in elderly patients undergoing gastrointestinal surgery. The study aims to answer the following main questions
- whether it reduces the expression of inflammatory factors in the acute postoperative period
- whether it can reduce the incidence of postoperative delirium
详细描述
Existing clinical studies have shown that TEAS has demonstrated value in preventing postoperative delirium (POD). Currently, taVNS is commonly used clinically to improve patients' cognitive dysfunction (POCD), and POD is often considered a precursor to the development of POCD. However, no one has yet used the two in combination, so this study aimed to combine the two to investigate their potential benefits in preventing POD.
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
- Triple (Participant, 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
- •Aged ≥65 years;
- •Body mass index (BMI) 18-30 kg/m²;
- •American Society of Anesthesiologists (ASA) physical status classification I-III;
- •Patients scheduled for elective laparoscopic gastrointestinal surgery;
- •Willingness to provide written informed consent and comply with the treatment regimen;
- •Absence of severe organic diseases, psychiatric disorders, or preoperative delirium.
排除标准
- •Preoperative Mini-Mental State Examination (MMSE) score <20;
- •Electrocardiographic evidence of severe bradycardia (heart rate <50 beats per minute);
- •Presence of skin lesions or infections at the electrical stimulation site;
- •History of preoperative chemotherapy or radiotherapy;
- •Concomitant severe organic diseases with compromised tolerance to interventions;
- •Prior exposure to Transcutaneous Electrical Acupoint Stimulation (TEAS) or transcutaneous auricular vagus nerve stimulation (taVNS) with documented insensitivity;
- •Inability to communicate normally, dementia, hearing impairment, or severe psychiatric disorders.
研究组 & 干预措施
Group A
Prior to induction of anaesthesia, patients in this group received transcutaneous electrical stimulation of acupuncture points for 30 min, followed by standardised anaesthesia.
干预措施: Transcutaneous electrical acupoint stimulation (Device)
Group B
Prior to induction of anaesthesia, patients in this group received transcutaneous electrical acupoint stimulation combined with auricular vagus nerve stimulation for a total of 30 min, followed by standardised anaesthesia.
干预措施: Transcutaneous electrical acupoint stimulation combined with auricular vagus nerve stimulation (Device)
结局指标
主要结局
Incidence of postoperative delirium
时间窗: The first to third days after surgery
Whether delirium occurred after surgery（by 3D-CAM）
次要结局
- IL-6 andTNF-α level(before operation（Before anesthesia），the end of the operation（Immediately after the sewing is finished）)
- VAS pain score(The first to third days after surgery)
- Early activities(Post-operative period until discharge（in about a week）)
- Time to first postoperative anal defecation(Post-operative period until discharge（In about a week）)
- Adverse events(The first to third days after surgery)
- Adverse events(The first to third days after surgery)
- IL-6 andTNF-α level(before operation（Before anesthesia），the end of the operation（Immediately after the sewing is finished）)
- Time to first postoperative anal defecation(Post-operative period until discharge（In about a week）)
- Early activities(Post-operative period until discharge（in about a week）)
- VAS pain score(The first to third days after surgery)
研究者
Lulu Ji
Attending physician
Affiliated Hospital of Nantong University