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

Phase 1

• Conditions: Jaundice, Obstructive; Systemic Inflammatory Response Syndrome
• Interventions: Drug: neostigmine methylsulfate，raceanisodamine hydrochloride

• Registration Number: NCT02279147
• Lead Sponsor: Wanqing Gu

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.

Study Timeline

• Study Start: 2014-08
• Study First Submitted: 2014-09-22
• Status Verified: 2014-10
• Study First Submitted QC: 2014-10-28
• Last Update Submitted: 2014-10-28
• Study First Posted: 2014-10-30
• Last Update Posted: 2014-10-30
• Primary Completion: 2017-08
• Study Completion: 2017-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
raceanisodamine & neostigmine	neostigmine methylsulfate，raceanisodamine hydrochloride	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.

Primary Outcome Measures

Name	Time	Method
C reactive protein	One year	Indicator of the stress level.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

CHN Chinese PLA General Hospital; 🇨🇳 Beijing, Beijing, China