Propofol Versus Midazolam for Upper Endoscopy in Cirrhotic Patients

NCT01141036 | Completed DMC

• 2 other identifiers: 006-08006-08ziv
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Upper GI endoscopy is often performed in patients with chronic liver disease to screen for esophageal and gastric varices. The purpose of this study is to compare propofol to midazolam for sedation in patients with chronic liver disease undergoing diagnostic upper GI endoscopy.

Conditions

Cirrhosis

Keywords

Propofol; Midazolam; sedation; cirrhosis; endoscopy; recovery time; efficacy and safety of sedation; patient satisfaction; return to baseline function; saturation of oxygen

Outcome Measures

Primary Outcomes (1)

• Exacerbation of hepatic encephalopathy

Secondary Outcomes (1)

• Recovery time, time to discharge

Study Arms (2)

propofol

ACTIVE COMPARATOR

propofol

Drug: propofol

Midazolam

ACTIVE COMPARATOR

Midazolam

Drug: Midazolam

Interventions

propofol DRUG

Propofol will be initiated with a 30-50 mg 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

Midazolam

Eligibility Criteria

• Age: 18 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 or B) 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:

• known allergy or adverse reaction to sedative or component thereof
• patients with known significant respiratory disease or airway abnormality)
• active neurological impairment including clinically detectable hepatic encephalopathy
• advanced or decompensated liver disease ( CP score \>10, MELD \>24) (Child-Pugh class C)
• active alcohol consumption or illicit drug abuse
• active prescription for sedation or narcotics

Sponsors & Collaborators

• Ziv Hospital: lead

Study Sites (1)

Ziv medical center liver unit

Safed, Israel, 13100, Israel

Location

MeSH Terms

Conditions

Fibrosis; Patient Satisfaction

Interventions

Propofol; Midazolam

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Treatment Adherence and Compliance; Health Behavior; Behavior

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 Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: June 8, 2010
• First Posted: June 10, 2010
• Study Start: July 1, 2008
• Primary Completion: January 1, 2009
• Study Completion: February 1, 2009
• Last Updated: June 10, 2010

Record last verified: 2010-06

Locations

IL (1)