Modified Tian Wang Bu Xin Dan Hydrogel Patch in Preventing Postoperative Delirium in Elderly Patients: A Muticenter Randomised Control Trial
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 200
- 试验地点
- 3
- 主要终点
- Incidence of inpatient post-operative delirium as measured using the 3D-confusion assessment method (3D-CAM)
研究概览
简要总结
The purpose of this study is to determine whether preoperative administration of Modified Tian Wang Bu Xin Dan Hydrogel Patch prevents the incidence of postoperative delirium in elderly patients undergoing major surgery.
详细描述
The Traditional Chinese Medicine (TCM) Tian Wang Bu Xin Dan (TWBXD, Cheonwangbosimdan), first recorded in Effective Formulae Handed Down for Generations ( Shi Yi De Xiao Fang) in 1337, is a herbal medicine that has been continuously utilized in Chinese medicine. It alleviates insomnia, anxiety, and palpitation by furnishing energy and stabilizing patients' mind. Cheonwangbosimdan can mitigate primary insomnia and secondary insomnia in patients with hyperthyroidism and menopause without severe side effects.
Tianwang Buxin Decoction has the same effect as Olanzapine for the treatment of delirium after hip joint replacement in falling-induced senile femoral neck fracture patients.
This study aim to evaluate the incidence of postoperative delirium in elderly patients treated with prophylactic Modified Cheonwangbosimdan Hydrogel Patch versus placebo patch.
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, Care Provider)
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients' age ≥70 years;
- •Underwent elective non-cardiac surgery (including Orthopedics, thoracic, urology, general surgery patients)under general anesthesia ;
排除标准
- •History of neuropsychiatric diseases including delirium, mental disorders, Parkinson, dementia, etc.;
- •The operation was cancelled due to various reasons after the patient was enrolled;
- •severe liver disease; severe renal dysfunction defined as either having creatinine clearance < 30 ml/min or being dialysis-dependent;
- •Patients who undergo second operation in a short period;
- •Past 30-day prescribed use of sedative-hypnotics for the indication of insomnia;
- •History of alcohol abuse or a history of drug dependence;
- •Cannot with the completion of tests of cognitive function;
- •Known allergy to skin patch;
- •Treatment site has active skin lesion or inflammation;
- •Refused to participate in the study.
研究组 & 干预措施
modified Cheonwangbosimdan Hydrogel patch
Group receiving modified Cheonwangbosimdan Hydrogel patch
干预措施: modified Tian Wang Bu Xin Dan hydrogel patch (Drug)
Placebo patch
Group receiving placebo patch
干预措施: placebo patch (Other)
结局指标
主要结局
Incidence of inpatient post-operative delirium as measured using the 3D-confusion assessment method (3D-CAM)
时间窗: Day 3 postoperatively
Occurrence of delirium on any postoperative day, as assessed using the 3D-CAM or CAM-ICU daily
次要结局
- Sleep Quality(Baseline and 1,3 days after surgery)
- Athens Insomnia Scale(Baseline and 1,2,3 days after surgery)
- Pain at rest using Numerical Rating Scale(NRS)(postoperative days 1, 2, 3)
- Total postoperative analgesic requirements(First 48 hours postoperatively)
- Change in biological markers (1)(Baseline and 1 day after surgery)
- Change in biological markers (2)(Baseline and 1 day after surgery)
- STOP-Bang score(Baseline)
- Pittsburgh Sleep Quality Index(Baseline and day 3 postoperatively)
研究者
Weidong Mi
Director (Cheif expert of National key research and development program of China 2018YFC2001900)
Chinese PLA General Hospital