Cholinergic Anti-inflammatory Pathway in Prevention & Treatment of the SIRS in Patients With Jaundice After Operation.
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|ClinicalTrials.gov Identifier: NCT02279147|
Recruitment Status : Unknown
Verified October 2014 by Wanqing Gu, Chinese PLA General Hospital.
Recruitment status was: Recruiting
First Posted : October 30, 2014
Last Update Posted : October 30, 2014
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 .
|Condition or disease||Intervention/treatment||Phase|
|Systemic Inflammatory Response Syndrome Jaundice, Obstructive||Drug: neostigmine methylsulfate，raceanisodamine hydrochloride||Phase 1 Phase 2|
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 (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||The Prevention and Treatment of SIRS in Patients With Cholestatic Jaundice After Operation.|
|Study Start Date :||August 2014|
|Estimated Primary Completion Date :||August 2017|
|Estimated Study Completion Date :||September 2017|
Experimental: 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.
Drug: neostigmine 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.
No Intervention: blank
Patients do not receive special treatment after operation.
- C reactive protein [ Time Frame: One year ]Indicator of the stress level.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02279147
|Contact: Wanqing GU, MDfirstname.lastname@example.org|
|Contact: Yurong LIANG, MDemail@example.com|
|CHN Chinese PLA General Hospital||Recruiting|
|Beijing, Beijing, China, 100853|
|Principal Investigator: GU wanqing|
|Study Chair:||GU wanqing||CHN Chinese PLA General Hospital|