Trial Comparing Sedation for Endoscopy With Propofol Versus Midazolam in Cirrhotics

NCT01356121 | Unknown Phase 4 DMC

• 1 other identifier: 5289617
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Conditions

Hepatic Encephalopathy

Outcome Measures

Primary Outcomes (1)

• Exacerbation of hepatic encephalopathy

  2 hr

Secondary Outcomes (2)

• Recovery time

  2 hr

• Time to discharge

  2 hr

Study Arms (3)

Midazolam

ACTIVE COMPARATOR

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

Drug: Midazolam

Propofol

ACTIVE COMPARATOR

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.

Drug: Propofol

No Sedation

NO INTERVENTION

No sedation given in this group

Interventions

Propofol DRUG

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.

Propofol

Midazolam DRUG

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

Also known as: Midazolaam

Midazolam

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Govind Ballabh Pant Hospital: lead

Study Sites (1)

Prof Barjesh Chander Sharma

New Delhi, National Capital Territory of Delhi, 110002, India

RECRUITING

Related Publications (1)

• 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.

  PMID: 22861074 DERIVED

MeSH Terms

Conditions

Hepatic Encephalopathy

Interventions

Propofol; Midazolam

Condition Hierarchy (Ancestors)

Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases; Brain Diseases, Metabolic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Barjesh C Sharma, MD,DM

  Govind Ballabh Pant Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Barjesh C Sharma, MD,DM

CONTACT

9718599203; drbcsharma@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: May 16, 2011
• First Posted: May 19, 2011
• Study Start: November 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: July 1, 2011
• Last Updated: May 19, 2011

Record last verified: 2011-03

Locations

IN (1)