Trial Comparing Sedation for Endoscopy With Propofol Versus Midazolam in Cirrhotics

Phase 4

• Conditions: Hepatic Encephalopathy
• Interventions: Drug: Propofol; Drug: Midazolam

• Registration Number: NCT01356121
• Lead Sponsor: Govind Ballabh Pant Hospital

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

Study Timeline

• Study Start: 2010-11
• Status Verified: 2011-03
• Study First Submitted: 2011-05-16
• Study First Submitted QC: 2011-05-17
• Last Update Submitted: 2011-05-17
• Study First Posted: 2011-05-19
• Last Update Posted: 2011-05-19
• Primary Completion: 2011-06
• Study Completion: 2011-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Propofol	Propofol	Propofol will be initiated with a 0.5-1 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	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

Primary Outcome Measures

Name	Time	Method
Exacerbation of hepatic encephalopathy	2 hr

Secondary Outcome Measures

Name	Time	Method
Time to discharge	2 hr
Recovery time	2 hr

Trial Locations

Locations (1)

Prof Barjesh Chander Sharma; 🇮🇳 New Delhi, Delhi, India