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

Wanqing Gu

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Jaundice, Obstructive; Systemic Inflammatory Response Syndrome

Treatments: Drug: neostigmine methylsulfate，raceanisodamine hydrochloride

Study type: Interventional

Funder types: Other

Identifiers

NCT02279147

CHN-PLAGH-WGu-001

Details and patient eligibility

About

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 .

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

raceanisodamine & neostigmine

Experimental group

Description:

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.

Treatment:

Drug: neostigmine methylsulfate，raceanisodamine hydrochloride

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No Intervention group

Description:

Patients do not receive special treatment after operation.