Effect of Continuous Theta Burst Stimulation (cTBS) on Postoperative Delirium
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 324
- 试验地点
- 1
- 主要终点
- Incidence of postoperative delirium
研究概览
简要总结
To investigate the impact of cTBS on the incidence of postoperative delirium and changes of cognitive function in elderly patients after surgery. To explore whether short-term cTBS can reduce the risk of postoperative delirium as a preventive strategy.
详细描述
Postoperative delirium is the most common postoperative complications among elderly. Nevertheless, there remains no effective medication or intervention been approved in postoperative delirium. Recent research suggests that continuous theta burst stimulation (cTBS) has shown positive effect on improving global cognitive function in multiple mental disorders. However, the effects on cognitive function in postoperative delirium remain uninvestigated.
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, Care Provider, Investigator)
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
- •Participants were included if they:
- •were 65 years old or older;
- •had orthopedic surgery under general anesthesia;
- •had normal cognitive function at enrolment [for illiterate, Mini-Mental State Examination (MMSE) ≥ 17; for individuals with 1-6 years of education, MMSE ≥ 20; for individuals with 7 or more years of education, MMSE ≥ 24];
- •were able to complete cognitive assessments and the Confusion Assessment Method (CAM);
- •Chinese Mandarin as their native language;
- •were willing to participate and being competent to provide informed consent.
- •Patients were excluded if they:
- •had delirium assessed by CAM before surgery;
- •had neurological diseases (e.g., stroke, Parkinson's disease, etc.) according to International Statistical Classification of Diseases and Related Health Problems 11th Revision (ICD-11);
- •had mental disorders (e.g., major depressive disorder, dementia, etc.) according to Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition) (DSM-5);
- •had contraindications of cTBS (e.g., head trauma, history of epilepsy or metal implants in the head);
- •participating in other clinical studies at the time of screening;
- •having postoperative complications such as pulmonary infection, pulmonary embolism and stroke.
排除标准
- 未提供
结局指标
主要结局
Incidence of postoperative delirium
时间窗: 3 days after surgery
Incidence of postoperative delirium on postoperative day 1, 2 and 3 was defined according to the confusion assessment methods (CAM).
Cognitive function related to delirium
时间窗: 3 days after surgery
The cognitive function related to delirium was assessed by using Delirium Symptom Interview Daily (DSI Daily).
Severity of postoperative delirium
时间窗: 3 days after surgery
Severity of postoperative delirium on postoperative day 1, 2 and 3 was defined according to he Confusion Assessment Method based delirium severity evaluation tool (CAM-S).The sum score of CAM-S ranges from 0 (no) to 19 (most severe).
次要结局
- Pain level(3 days after surgery)
- Sleep quality(3 days after surgery)
- Ability of daily living(up to 7 days after anesthesia/surgery)
- Rate of complication and mortality(up to 7 days after anesthesia/surgery)
研究者
Yuan Shen, MD, PhD
Chief of Psychiatry
Shanghai 10th People's Hospital