Propofol Versus Midazolam for Upper Endoscopy in Cirrhotic Patients

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.

Study Overview

• Status: Completed
• Conditions: Cirrhosis
• Intervention / Treatment: Drug: Midazolam; Drug: propofol

Detailed Description

Background : Upper GI endoscopy is often performed in patients with chronic liver disease to screen for esophageal and gastric varices. AIM: The purpose of this study is to compare propofol to midazolam for sedation in patients with chronic liver disease undergoing diagnostic upper GI endoscopy. Methods: 60 outpatients who has known chronic liver disease (Child-Pugh class A or B) (cirrhosis) and are undergoing variceal screening will be randomized to receive propofol or midazolam for sedation. Administration of sedation was performed by a anesthesist. Outcome measures studied are induction and recovery times, efficacy and safety of sedation, patient satisfaction, and return to baseline function and subclinical hepatic encephalopathy (number connection test), and saturation of oxygen. expected results: The mean time to achieve adequate sedation will be shorter for for the propofol group in comparison to midazolam group. The level of sedation achieved by the propofol group will be greater. Time to full recovery will be faster in the propofol group. Propofol do not exacerbate subclinical hepatic encephalopathy as compared to midazolam. patients receiving propofol will express greater overall mean satisfaction with the quality of their sedation at the time of discharge. Conclusions: Propofol sedation is expected not to exacerbate subclinical hepatic encephalopathy in cirrhotics.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Safed, Israel, Israel, 13100
    • Ziv medical center liver unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Exclusion criteria will include the following:

  • 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: propofol	Drug: propofol; 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.
ACTIVE_COMPARATOR: Midazolam	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Exacerbation of hepatic encephalopathy

Secondary Outcome Measures

Outcome Measure
Recovery time, time to discharge

Collaborators and Investigators

• Sponsor: Ziv Hospital

Study record dates

Study Major Dates

• Study Start: July 1, 2008
• Primary Completion (ACTUAL): January 1, 2009
• Study Completion (ACTUAL): February 1, 2009

Study Registration Dates

• First Submitted: June 8, 2010
• First Submitted That Met QC Criteria: June 9, 2010
• First Posted (ESTIMATE): June 10, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): June 10, 2010
• Last Update Submitted That Met QC Criteria: June 9, 2010
• Last Verified: June 1, 2010

More Information

Terms related to this study

• Keywords: endoscopy; Propofol; sedation; cirrhosis; Midazolam; patient satisfaction; recovery time; efficacy and safety of sedation; return to baseline function; saturation of oxygen
• Additional Relevant MeSH Terms: Pathologic Processes; Fibrosis; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Midazolam; Propofol
• Other Study ID Numbers: 006-08; 006-08ziv