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

Study Overview
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Brief Summary
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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 Description
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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.

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

Conditions
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Systemic Inflammatory Response Syndrome, Jaundice, Obstructive

Intervention / Treatment
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* Drug: neostigmine methylsulfate，raceanisodamine hydrochloride


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: raceanisodamine & neostigmine<br>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. | Drug: neostigmine methylsulfate，raceanisodamine hydrochloride<br>* 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.<br>|
| No Intervention: blank<br>Patients do not receive special treatment after operation. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| C reactive protein | Indicator of the stress level. | One year | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Systemic Inflammatory Response Syndrome, Jaundice, Obstructive, anti-inflammatory