Trial Comparing Sedation for Endoscopy With Propofol Versus Midazolam in Cirrhotics

NCT ID: NCT01356121

Last Updated: 2011-05-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2011-07-31

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

Conditions

Hepatic Encephalopathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Midazolam

Intervention Type: 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

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.

Group Type: ACTIVE_COMPARATOR

Propofol

Intervention Type: 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.

No Sedation

No sedation given in this group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DRUG

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

Intervention Type: DRUG

Other Intervention Names

Midazolaam

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Govind Ballabh Pant Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

G B Pant Hospital New Delhi 110002

Principal Investigators

Barjesh C Sharma, MD,DM

Role: PRINCIPAL_INVESTIGATOR

Govind Ballabh Pant Hospital

Locations

Prof Barjesh Chander Sharma

New Delhi, National Capital Territory of Delhi, India

Site Status: RECRUITING

Countries

India

Central Contacts

Barjesh C Sharma, MD,DM

Role: CONTACT

drbcsharma@hotmail.com

9718599203

Facility Contacts

Barjesh C Sharma, MD,DM

Role: primary

drbcsharma@hotmail.com

9718599203

Amit Agrawal, MD

Role: backup

amit_04_dr@yahoo.com

9718599214

References

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.

Reference Type: DERIVED

PMID: 22861074 (View on PubMed)

Other Identifiers

5289617

Identifier Type: -

Identifier Source: org_study_id