Clinical trial NCT01356121: Trial Comparing Sedation for Endoscopy With Propofol Versus Midazolam in Cirrhotics
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hepatic Encephalopathy
Lead sponsor: Govind Ballabh Pant Hospital
Sponsor class: OTHER_GOV
First posted: 2011-05-19
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Detailed 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

Eligibility criteria: Inclusion Criteria:

* Known chronic liver disease (Child-Pugh class A , B or C ) who presented for upper GI endoscopy for routine variceal screening.
* The diagnosis of liver disease will be based on available past history, serological testing, radiological imaging, and liver histology when available.
* Staging of cirrhosis will be determined by MELD score and by Child-Pugh score . All patients will complete a standard preprocedure history and physical examination to establish current degree of encephalopathy and ascites.

Exclusion Criteria:

* Active GI bleeding
* Overt encephalopathy
* Active alcohol intake during the past 6 weeks
* Significant co morbid illness such as heart, respiratory, or renal failure and any neurologic diseases such as alzheimer's disease, parkinson's disease and nonhepatic metabolic encephalopathies.
* Patients with known allergy to sedative
* hepatocellular carcinoma
* Previous TIPS or shunt surgery,
* Patients on psychoactive drugs, such as antidepressants or sedatives
* Patients with an American Society of Anesthesiology (ASA) physical status of class IV or V
* Patients with visual or mental impairment who will unable to complete the psychometric testing or CFF

Primary outcomes:
measure: Exacerbation of hepatic encephalopathy
timeFrame: 2 hr
Secondary outcomes:
measure: Recovery time
timeFrame: 2 hr
measure: Time to discharge
timeFrame: 2 hr
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Prof Barjesh Chander Sharma
state: Delhi
Study officials:
affiliation: Govind Ballabh Pant Hospital
name: Barjesh C Sharma, MD,DM
role: PRINCIPAL_INVESTIGATOR
References:
citation: Agrawal A, Sharma BC, Sharma P, Uppal R, Sarin SK. Randomized controlled trial for endoscopy with propofol versus midazolam on psychometric tests and critical flicker frequency in people with cirrhosis. J Gastroenterol Hepatol. 2012 Nov;27(11):1726-32. doi: 10.1111/j.1440-1746.2012.07231.x.