Effect of Dexamethasone on Postoperative Inflammatory Factors in Elderly Patients Undergoing Lunmbar Spine Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- the change of Inflammatory mediators in the drainage fluid
研究概览
简要总结
This topic foe randomized prospective study.Detection of elderly patients with lunmbar spinal postoperative inflammatory substances in the blood and drainage of liquid level ,clear whether low-dose dexamethasone can inhibit the inflammation, the observation of elderly patients with lumbar spinal postoperative drainage star, to explor whether low-dose dexamthasone can reduce postoperative incision drainage, thus impove the postoprative drainage tube pull rate within three days, which in turn reduce because of the place a retrograde infection caused by drainage tube.
详细描述
A total of 100 patients undergoing posterior lumbar disc fusion were randomly divided into control group (group C,n=50) and dexamethasone group (group D,n=50). Group D was given 0.15mg/kg dexamethasone (2ml) intravenously after anesthesia induction. Group C was also intravenously injected with 2ml normal saline after anesthesia induction.On this basis, monitor the main results and secondary results
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
- •Adult patients ≥65years of age
- •American Society of Anesthesiologists (ASA) physical status 2-4
- •Elective or expedited non-cardiac surgery of at least 2 hours dura- tion under general anaesthesia
- •Requiring a hospital stay of at least one postoperative night
- •A surgical skin incision >5 cm in length or multiple incisions with a total incision length of >5 cm
排除标准
- •Poorly controlled diabetes (HbA1c>9.0%)
- •Endovascular procedure with a small (<5 cm length) skin incision Ophthalmic surgery
- •Planned dexamethasone (or other corticosteroid) therapy (eg, history of intractable PONV, maxillofacial surgery, intracranial neurosurgery)
- •Recent (<2 weeks since end of treatment) infective episode requir- ing treatment with antibiotics
- •Chronic antibiotic therapy (eg, for bronchiectasis, cystic fibrosis etc)
研究组 & 干预措施
Group Dexamethasone
Group dexamethasone patients received intravenous injection after anesthesia induction
Injection 0.15mg/kg dexamethasone (2ml）
干预措施: Dexamethasone Injection (Drug)
Group Saline
Group Control patients were also given 2ml of normal saline intravenously after induction of anesthesia
干预措施: Normal saline (Drug)
结局指标
主要结局
the change of Inflammatory mediators in the drainage fluid
时间窗: 6 hours after surgery， the morning of 1, 2, and 3 days after surgery
CRP(mg/ L) in postoperative drainage fluid was observed
the change of drainage fluid volume
时间窗: 6 hours after surgery， the morning of 1, 2, and 3 days after surgery
Drainage fluid （ml）was collected and the volume of drainage fluid was recorded Until the drainage tube was pulled out,
次要结局
- the change of blood inflammatory mediators(6 hours after surgery， the morning of 1, 2, and 3 days after surgery)
- the change of blood routine white blood cell count(6 hours after surgery， the morning of 1, 2, and 3 days after surgery)