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 Details — Status: Recruiting

Administrative data

• NCT number: NCT01356121
• Other study ID #: 5289617
• Status: Recruiting
• Phase: Phase 4
• First received: May 16, 2011
• Last updated: May 17, 2011
• Start date: November 2010
• Est. completion date: July 2011

Study information

• Verified date: March 2011
• Source: Govind Ballabh Pant Hospital
• Contact: Barjesh C Sharma, MD,DM
• Phone: 9718599203
• Email: drbcsharma[@]hotmail.com
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: July 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

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

• Brain Diseases
• Hepatic Encephalopathy

Intervention

Drug:
• Propofol
Propofol will be initiated with a .5-1 mg/kg i.v. bolus followed by repeated 10-20 mg doses at variable intervals (approximately 15 s, at the discretion of the endoscopist/nurse) until an appropriate level of sedation will be achieved.
• Midazolam
Midazolam (0.5-1.0 mg) will be administered in a similar fashion with incremental dosing at intervals of approximately 1-3 min until a level of sedation will be achieved

Locations

Country	Name	City	State
India	Prof Barjesh Chander Sharma	New Delhi	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Govind Ballabh Pant Hospital

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exacerbation of hepatic encephalopathy		2 hr	Yes
Secondary	Recovery time		2 hr	No
Secondary	Time to discharge		2 hr	No