POD and Postoperative Outcomes in Senile Patients After SFI for Hip Fracture Surgery: A Randomized Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 350
- 主要终点
- incidence of postoperative delirium within 7 days
研究概览
简要总结
Surgery or trauma may cause serious problem to patients, especially for senile ones, like postoperative delirium or more postoperative complications. Here, we conduct a investigation of SFI for preventing the happening of POD or postoperative complications.
详细描述
SFI(Shenfu Injection), a historical medical herbal medicine of traditional Chinese, which may produced much benefit to clinical patients with furtigue after major surgery, because it was a comment sense to think of energy loss if they experience surgical damage. Here, we administrated intravenously SFI into senile patients, who receiving hip fracture surgery, to avoid bad results or serious postoperative outcomes, in case of enhancing recovery after surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 75 Years 至 90 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •hip fracture surgery under epidural anesthesia
排除标准
- •Severe dementia, hearing/vision impairment, coma, etc., unable to communicate;
- •patients with end-stage diseases such as tumor;
- •3 months after myocardial infarction, cerebral infarction;
- •severe heart, liver and renal dysfunction.
研究组 & 干预措施
SFI intervention group
shenfu injection used during surgery, day one and two after surgery, 50ml,iv drop.
干预措施: Shen-Fu injection (Drug)
Control group
same volume of normal saline used during surgery, day one and two after surgery, 50ml,iv drop.
干预措施: normal saline (Drug)
结局指标
主要结局
incidence of postoperative delirium within 7 days
时间窗: day 1-7 after surgery, more scores means higher incidence of POD
postoperative delirium(POD), assessed with Confusion Assessment Method scale and Richmond Agitation-Sedation Scale together.
次要结局
- length of stay(approximately day 1 in hospital to day 7)
- all-caused mortality within 30 days(30 days after surgery)
- non-delirium complications(day 1-7 after surgery)
- pain assessment within 3 days(day 1-3 after surgery, higher scores mean more pain.)
- survival in 1 year(1 year discharge from hospital)
- adverse events to shenfu injection(approximately day1-7 after surgery)
研究者
weiliang zhang
Principal Investigator
Shandong University of Traditional Chinese Medicine