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Trial Comparing Sedation for Endoscopy With Propofol Versus Midazolam in Cirrhotics

Hepatic Encephalopathy Clinical Trial

Official title:
Randomized Controlled Trial Comparing Effects of Sedation for Upper Gastrointestinal Endoscopy With Propofol Versus Midazolam on Psychometric Tests and Critical Flicker Frequency in Cirrhotics

Clinical Trial Summary

To compare effects of sedation for upper gastrointestinal endoscopy with propofol and midazolam on psychometric tests and critical flicker frequency (CFF) in cirrhotics

Clinical Trial Description

Upper GI Endoscopy is routinely performed in patients with chronic liver disease to screen for complications related to portal hypertension such as esophageal and gastric varices and portal gastropathy. Sedation is frequently administered to facilitate patient tolerance.Patients with hepatic dysfunction who undergo endoscopy are at increased risk for complications related to sedation.Propofol has a favorable pharmacokinetic profile in comparison with benzodiazepines and opioids, which makes it especially appropriate for sedation in endoscopy.In previous studies cognitive functions were assessed by various paper and pencil tests. However learning affects the paper and pencil tests if repeated at short interval of time.CFF analysis was found to be sensitive and objective in the quantification of low-grade HE, and there is a significant correlation between CFF and the portosystemic encephalopathy syndrome (PHES) battery.Considering this, we designed a prospective randomized controlled study with cirrhotic outpatients to compare effects of sedation for upper gastrointestinal endoscopy with propofol versus midazolam on psychometric tests and critical flicker frequency in cirrhotics ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01356121
Study type Interventional
Source Govind Ballabh Pant Hospital
Contact Barjesh C Sharma, MD,DM
Phone 9718599203
Email drbcsharma@hotmail.com
Status Recruiting
Phase Phase 4
Start date November 2010
Completion date July 2011
View Details
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