The Prevention and Treatment of SIRS in Patients With Cholestatic Jaundice After Operation.
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- C reactive protein
研究概览
简要总结
RATIONALE:Anticholinesterase drugs and cholinergic M receptor antagonist are applied to patients who have obstructive jaundice after operation.
PURPOSE:This clinical trial was designed to lower the incidence and mortality of operation complications in patients with obstructive jaundice .
详细描述
OBJECTIVES:
Ⅰ.Judge whether it has the effect of inhibiting inflammation, anti oxidative stress and anti apoptosis when the alpha 7 nicotinic acetylcholine receptors are activated .
Ⅱ.Judge whether it has the effect of reducing the incidence and mortality of operation complication when using Cholinesterase inhibitors and M cholinergic receptor blocking agent in Patients with obstructive jaundice after operation。
OUTLINE:Patients are assigned to 1 of 2 groups according to order of enrollment.
Group 1:Patients receive neostigmine methylsulfate and raceanisodamine hydrochloride on days 0,1,2 after operation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ⅰ.Accompanied by obstructive jaundice and plans to implement the liver resection of hilar bile duct carcinoma.
- •Patients with carcinoma of head of pancreas and plans to implement pancreaticoduodenectomy.
- •Ⅱ. Drugs which were used in the clinical trials is safe for patients.
- •Ⅲ.The patients did not occur the complication which would affect the experimental observation seriously after the operation.
- •Ⅳ.The patients agreed to participate in this clinical trial and sign the informed consent.
排除标准
- •Ⅰ.Patients are unwilling to accept the clinical trials or researchers believe that patients can not in compliance with the requirements of clinical research.
- •Ⅱ.Patients with tumor metastases widely or can not accept a predetermined operation scheme.
- •Ⅲ. The postoperative complications or other therapeutic measures take will affect the experimental observation seriously.
研究组 & 干预措施
raceanisodamine & neostigmine
Patients receive immediately raceanisodamine（10mg）by intramuscular injection after operation.Then the patients will be receive 50mg raceanisodamine and 0.15mg neostigmine within 24hs by slow injection into vein for three consecutive days.
干预措施: neostigmine methylsulfate，raceanisodamine hydrochloride (Drug)
结局指标
主要结局
C reactive protein
时间窗: One year
Indicator of the stress level.
次要结局
- Aspartate aminotransferase（AST）(One year)
- Tumor necrosis factor-α(One year)
- Temperature(One year)
- Heart rate(One year)
- PaCO2(One year)
- Interleukin 10（ IL-10）(One year)
- Respiratory(One year)
- White blood cell count(one year)
- Triiodothyronine(T3) & Thyroxin(T4) & Thyroid stimulating hormone(TSH)(One year)
- Alanine aminotransferase（ALT)(One year)
- Total bilirubin(One year)
- Interleukin 1（IL-1）(One year)
- Interleukin 2（IL-2）(One year)
- Interleukin 6（IL-6）(One year)
- Interleukin 8（ IL-8）(One year)
研究者
Wanqing Gu
The Prevention and Treatment of SIRS in Patients With Cholestatic Jaundice After Operation.
Chinese PLA General Hospital