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 .
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
100
The patients receive immediately raceanisodamine hydrochloride(10mg) by intramuscular injection after operation .From that date, for three consecutive days, the patients will be receive 50mg raceanisodamine hydrochloride and 0.15mg neostigmine methylsulfate in the 24h by slow injection of vein.
CHN Chinese PLA General Hospital
Beijing, Beijing Municipality, China
RECRUITINGC reactive protein
Indicator of the stress level.
Time frame: One year
Temperature
Indicator of systemic inflammatory response syndrome.
Time frame: One year
Heart rate
Indicator of systemic inflammatory response syndrome.
Time frame: One year
Respiratory
Indicator of systemic inflammatory response syndrome.
Time frame: One year
PaCO2
Indicator of systemic inflammatory response syndrome.
Time frame: One year
White blood cell count
Indicator of systemic inflammatory response syndrome.
Time frame: one year
Alanine aminotransferase(ALT)
Indicators of liver function.
Time frame: One year
Aspartate aminotransferase(AST)
Indicators of liver function.
Time frame: One year
Total bilirubin
Indicators of liver function.
Time frame: One year
Interleukin 1(IL-1)
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Indicators of pro-inflammatory mediators
Time frame: One year
Interleukin 2(IL-2)
Pro-inflammatory mediators.
Time frame: One year
Interleukin 6(IL-6)
Pro-inflammatory mediators.
Time frame: One year
Interleukin 8( IL-8)
Pro-inflammatory mediators
Time frame: One year
Tumor necrosis factor-α
Pro-inflammatory mediators.
Time frame: One year
Interleukin 10( IL-10)
Anti-inflammatory mediators
Time frame: One year
Triiodothyronine(T3) & Thyroxin(T4) & Thyroid stimulating hormone(TSH)
Indicators of the stress level.
Time frame: One year