Electroacupuncture for Preventing Postoperative Delirium in Older Adults Undergoing Total Knee Arthroplasty: a Multicentre Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,460
- 试验地点
- 1
- 主要终点
- The incidence of postoperative delirium within the first three postoperative days
研究概览
简要总结
Electroacupuncture may improve cognitive function and altered consciousness, but its effect on postoperative delirium in older arthroplasty patients remains unexplored. This study aims to assess the efficacy of electroacupuncture in preventing postoperative delirium in older adults undergoing total knee arthroplasty.
详细描述
Electroacupuncture combines traditional acupuncture with electrical stimulation at specific body points. Recent clinical studies have shown promising results for acupuncture-related techniques in managing perioperative neurocognitive disorders. However, the efficacy of electroacupuncture in preventing postoperative delirium in elderly patients undergoing total knee arthroplasty remains unexplored.This randomised controlled trial aims to evaluate the efficacy of electroacupuncture in preventing postoperative delirium in elderly patients undergoing total knee arthroplasty.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 90 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 65-90 years
- •American Society of Anaesthesiologists (ASA) physical status class II or III
- •Scheduled for elective unilateral total knee arthroplasty under general anesthesia
排除标准
- •Baseline dementia or Mini-Mental State Examination (MMSE) score below 24
- •Implanted electrical devices (eg, pacemakers, brain or spinal cord neurostimulator)
- •Infection or abscess at any selected acupuncture point
- •Severe hematopoietic or hemorrhagic disease
- •Severe audio-visual impairments or inability to communicate in Mandarin
- •Alcohol or illicit drug misuse disorder
- •Current use of sedatives, antidepressants or glucocorticoids
- •Received acupuncture or electroacupuncture within one month before surgery
- •Any condition deemed unsafe or unsuitable by the research team
结局指标
主要结局
The incidence of postoperative delirium within the first three postoperative days
时间窗: At least two hours postsurgery and twice daily (09:00-11:00 and 18:00-20:00) for three days
The incidence of POD within the first three postoperative days will be assessed using the Confusion Assessment Method (CAM). The CAM evaluates four diagnostic features: (1) acute onset or fluctuating course, (2) inattention, (3) disorganised thinking and (4) altered consciousness. Delirium is diagnosed when features 1 and 2 are present, with either 3 or 4. Blinded investigators will assess for POD at least two hours postsurgery and twice daily (09:00-11:00 and 18:00-20:00) for three days.
次要结局
- Cognitive function(At 1, 3, 6 and 12 months postoperatively)
- Delirium severity(At least two hours postsurgery and twice daily (09:00-11:00 and 18:00-20:00) for three days)
- Postoperative pain(Assessed at 1, 3, 6, 12, 24, 36, 48, 60 and 72 hours postsurgery)
- Postoperative morphine consumption(During 72 hours postsurgery)
- Recovery quality(Assessed daily for three days postoperatively)
- Sleep quality(Assessed preoperatively and daily for three days postoperatively)
- Delirium subtypes(At least two hours postsurgery and twice daily (09:00-11:00 and 18:00-20:00) for three days)
- Adverse events(through study completion, an average of 7 days)
- Anxiety and depression(Assessed preoperatively and daily for three days postoperatively)
研究者
Yao Yusheng
Professor
Fujian Provincial Hospital