Jaundice, Obstructive, Systemic Inflammatory Response Syndrome
Conditions
Keywords
Systemic Inflammatory Response Syndrome, Jaundice, Obstructive, anti-inflammatory
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 description
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.
Interventions
DRUGneostigmine methylsulfate，raceanisodamine hydrochloride
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.
Sponsors
Wanqing Gu
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| C reactive protein | One year | Indicator of the stress level. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Heart rate | One year | Indicator of systemic inflammatory response syndrome. |
| Respiratory | One year | Indicator of systemic inflammatory response syndrome. |
| PaCO2 | One year | Indicator of systemic inflammatory response syndrome. |
| White blood cell count | one year | Indicator of systemic inflammatory response syndrome. |
| Alanine aminotransferase（ALT) | One year | Indicators of liver function. |
| Aspartate aminotransferase（AST） | One year | Indicators of liver function. |
| Total bilirubin | One year | Indicators of liver function. |
| Temperature | One year | Indicator of systemic inflammatory response syndrome. |
| Interleukin 2（IL-2） | One year | Pro-inflammatory mediators. |
| Interleukin 6（IL-6） | One year | Pro-inflammatory mediators. |
| Interleukin 8（ IL-8） | One year | Pro-inflammatory mediators |
| Tumor necrosis factor-α | One year | Pro-inflammatory mediators. |
| Interleukin 10（ IL-10） | One year | Anti-inflammatory mediators |
| Triiodothyronine(T3) & Thyroxin(T4) & Thyroid stimulating hormone(TSH) | One year | Indicators of the stress level. |
| Interleukin 1（IL-1） | One year | Indicators of pro-inflammatory mediators |
Countries
China
Contacts
Primary ContactWanqing GU, MD
Backup ContactYurong LIANG, MD
Outcome results
None listed