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

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

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 .

Study Overview

• Status: Unknown
• Conditions: Systemic Inflammatory Response Syndrome; Jaundice, Obstructive
• Intervention / Treatment: Drug: neostigmine methylsulfate，raceanisodamine hydrochloride

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Wanqing GU, MD; Phone Number: +86-10-66938334; Email: 13366779198@163.com
• Study Contact Backup: Name: Yurong LIANG, MD; Phone Number: +86-10-66938334; Email: yurongliang@hotmail.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100853
      • Recruiting
      • CHN Chinese PLA General Hospital
      • Principal Investigator: GU wanqing

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Wanqing Gu
• Investigators: Study Chair: GU wanqing, CHN Chinese PLA General Hospital

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (Anticipated): August 1, 2017
• Study Completion (Anticipated): September 1, 2017

Study Registration Dates

• First Submitted: September 22, 2014
• First Submitted That Met QC Criteria: October 28, 2014
• First Posted (Estimate): October 30, 2014

Study Record Updates

• Last Update Posted (Estimate): October 30, 2014
• Last Update Submitted That Met QC Criteria: October 28, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Keywords: anti-inflammatory; Systemic Inflammatory Response Syndrome; Jaundice, Obstructive
• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation; Shock; Skin Manifestations; Hyperbilirubinemia; Systemic Inflammatory Response Syndrome; Jaundice; Jaundice, Obstructive; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Enzyme Inhibitors; Cholinesterase Inhibitors; Parasympathomimetics; Neostigmine
• Other Study ID Numbers: CHN-PLAGH-WGu-001