NCT04017403Unknown不适用
Probiotics Oral Administration Attenuate Postoperative Cognition Decline in Elderly Orthopedic Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 220
- 试验地点
- 3
- 主要终点
- Incidence of POCD 7days after surgery
研究概览
简要总结
The aim of this study was to evaluate whether perioperative probiotics can reduce the incidence of postoperative cognitive dysfunction and postoperative delirium.
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 80 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •. Age is greater than or equal to 65 years old
- •. Can communicate normally
- •. Selective knee ankle, hip replacement or lumbar open reduction and internal fixation under general anesthesia
- •. ASA graded at I-II level
- •. Patient or family informed consent
排除标准
- •. Have a brain disease, or have a history of brain disease
- •.MMSE check of less than 24 points.
- •. History of neurological and psychological disorders including AD, stroke, psychosis
- •. Serious hearing or visual impairment
- •. Preoperative systolic blood pressure >190mmhg, or diastolic blood pressure >100mmhg
- •. The patient or family refuses
研究组 & 干预措施
Placebo group
Placebo Comparator
The control group was given the same package of placebo,one day before surgery to the sixth day after surgery. The drug is taken orally, 4 capsules at a time, 2 times a day.
干预措施: Placebos (Drug)
Probiotic group
Experimental
The probiotic group was treated with Bifidobacterium tripleis,one day before surgery to the sixth day after surgerythe drug is taken orally, 4 capsules at a time, 2 times a day.
干预措施: Bifidobacterium triple live capsule (Drug)
结局指标
主要结局
Incidence of POCD 7days after surgery
时间窗: The seventh day after surgery
次要结局
- Incidence of POD 7 days after surgery(One day after surgery to the seventh day after surgery)
- Incidence of POCD 1 month after operation(One month after surgery)
研究者
研究点 (3)
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