NCT02279147

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.

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Wanqing Gu · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Systemic Inflammatory Response Syndrome
• Jaundice, Obstructive

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2014-08-01
• Primary completion: 2017-08-01
• Completion: 2017-09-01
• First posted: 2014-10-30
• Last updated: 2014-10-30

Locations

1 site across 1 country: China