Clinical Trial: Cholinergic Anti-inflammatory Pathway in Prevention & Treatment of the SIRS in Patients With Jaundice After Operation.

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: The Prevention and Treatment of SIRS in Patients With Cholestatic Jaundice After Operation.

Brief Summary:

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 .


Detailed Summary:

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.

Group 2:Patients do not receive any special treatment after operation.

All patients should be monitored the observed indexes on the day before the operation and one day, three days, five days after the operation.


Sponsor: Wanqing Gu

Current Primary Outcome: C reactive protein [ Time Frame: One year ]

Indicator of the stress level.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Temperature [ Time Frame: One year ]
    Indicator of systemic inflammatory response syndrome.
  • Heart rate [ Time Frame: One year ]
    Indicator of systemic inflammatory response syndrome.
  • Respiratory [ Time Frame: One year ]
    Indicator of systemic inflammatory response syndrome.
  • PaCO2 [ Time Frame: One year ]
    Indicator of systemic inflammatory response syndrome.
  • White blood cell count [ Time Frame: one year ]
    Indicator of systemic inflammatory response syndrome.
  • Alanine aminotransferase（ALT) [ Time Frame: One year ]
    Indicators of liver function.
  • Aspartate aminotransferase（AST） [ Time Frame: One year ]
    Indicators of liver function.
  • Total bilirubin [ Time Frame: One year ]
    Indicators of liver function.
  • Interleukin 1（IL-1） [ Time Frame: One year ]
    Indicators of pro-inflammatory mediators
  • Interleukin 2（IL-2） [ Time Frame: One year ]
    Pro-inflammatory mediators.
  • Interleukin 6（IL-6） [ Time Frame: One year ]
    Pro-inflammatory mediators.
  • Interleukin 8（ IL-8） [ Time Frame: One year ]
    Pro-inflammatory mediators
  • Tumor necrosis factor-α [ Time Frame: One year ]
    Pro-inflammatory mediators.
  • Interleukin 10（ IL-10） [ Time Frame: One year ]
    Anti-inflammatory mediators
  • Triiodothyronine(T3) & Thyroxin(T4) & Thyroid stimulating hormone(TSH) [ Time Frame: One year ]
    Indicators of the stress level.


Original Secondary Outcome: Same as current

Information By: Chinese PLA General Hospital

Dates:
Date Received: September 22, 2014
Date Started: August 2014
Date Completion: September 2017
Last Updated: October 28, 2014
Last Verified: October 2014