Trial Comparing Sedation for Endoscopy With Propofol Versus Midazolam in Cirrhotics

• Status: Unknown status
• Trial end date: 2011-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Govind Ballabh Pant Hospital
• Treatments: Midazolam; Propofol

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