Effects of Perioperative Repetitive Transcranial Magnetic Stimulation on Postoperative Delirium, Postoperative Cognitive Dysfunction, and Chronic Post-surgical Pain in Elderly Surgical Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 352
- 试验地点
- 1
- 主要终点
- Incidence of chronic postsurgical pain (CPSP) at 3 months after surgery
研究概览
简要总结
Exploring the effects of repeated transcranial magnetic stimulation (rTMS) during the perioperative period on the incidence of postoperative delirium, postoperative cognitive dysfunction, and chronic postoperative pain in elderly patients, as well as its possible mechanisms.
详细描述
Patients are recruited one week prior to the trial commencement, during which they are informed about the experimental protocol and associated risks. After obtaining informed consent and signatures, they are enrolled as study participants.Patients who meet the trial criteria are randomly assigned in a 1:1 ratio to the control group (sham rTMS group) and the intervention group (rTMS group, with rTMS intervention applied in the PACU after surgery) in a double-blind manner (with rTMS intervention and postoperative follow-up conducted by different researchers).
Note: This trial includes three co-primary outcomes-postoperative delirium (POD), postoperative cognitive dysfunction (POCD), and chronic postoperative pain (CPSP). To account for the different nature and timelines of these outcomes, the study was designed to include two parallel patient cohorts under a unified protocol:
- Elderly patients undergoing gastrointestinal surgery are enrolled primarily for the evaluation of POD, a short-term outcome assessed within 3 days postoperatively.
- Elderly patients undergoing thoracic surgery are enrolled to evaluate POCD (at 1 month) and CPSP (at 3 months), which are longer-term outcomes.
These two patient cohorts are studied concurrently but analyzed separately according to outcome-specific follow-up timelines and sample size estimations. A total of 122 gastrointestinal surgery patients were enrolled and analyzed for POD. The maximum estimated sample size is for the POCD and CPSP cohort (n=230). Results will be reported in phases corresponding to the completion of each outcome assessment.
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
- 60 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 60 years;
- •Elective surgery patients.
排除标准
- •Refusal to sign the consent form;
- •Mini-Mental State Examination (MMSE) score < 15;
- •Preoperative neuropsychiatric diseases and history of neurological or psychiatric disorders;
- •Preoperative cranial or scalp injuries;
- •History of drug or alcohol abuse; Visual or auditory impairments, communication difficulties; Presence of metallic implants in the body; Preoperative history of severe cardiovascular disease or severe liver or kidney dysfunction.
结局指标
主要结局
Incidence of chronic postsurgical pain (CPSP) at 3 months after surgery
时间窗: At 3 months after surgery
CPSP is defined as pain persisting for at least three months after surgery that was not present before surgery or that had different characteristics, and other possible causes of pain were excluded (e.g., cancer recurrence, infection). Pain intensity is assessed with the numeric rating scale, an 11-point scale where 0=no pain and 10=the worst pain, both at rest and with movement.
Incidence of delirium during the first 3 days after surgery
时间窗: The first 3 days after surgery
Delirium is assessed twice daily (8-10 AM and 6-8 PM) with the Confusion Assessment Method for patients without endotracheal intubation during the first 3 days after surgery.
Incidence of Postoperative Cognitive Dysfunction
时间窗: 1 month after surgery
Cognitive function assessed with MoCA (Montreal Cognitive Assessment) test on the 30th day after surgery
次要结局
未报告次要终点
研究者
Chaochao Zhong
Principal Investigator
Affiliated Hospital of Nantong University