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Propofol Versus Midazolam for Upper Endoscopy in Cirrhotic Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01141036
First Posted: June 10, 2010
Last Update Posted: June 10, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Ziv Hospital
  Purpose
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.

Condition Intervention
Cirrhosis Drug: propofol Drug: Midazolam

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Propofol Versus Midazolam for Upper Endoscopy in Cirrhotic Patients

Resource links provided by NLM:


Further study details as provided by Ziv Hospital:

Primary Outcome Measures:
  • Exacerbation of hepatic encephalopathy

Secondary Outcome Measures:
  • Recovery time, time to discharge

Estimated Enrollment: 60
Study Start Date: July 2008
Study Completion Date: February 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: propofol
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
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

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.
  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01141036


Locations
Israel
Ziv medical center liver unit
Safed, Israel, Israel, 13100
Sponsors and Collaborators
Ziv Hospital
  More Information

Responsible Party: Liver Clinic, Ziv medical center
ClinicalTrials.gov Identifier: NCT01141036     History of Changes
Other Study ID Numbers: 006-08
006-08ziv
First Submitted: June 8, 2010
First Posted: June 10, 2010
Last Update Posted: June 10, 2010
Last Verified: June 2010

Keywords provided by Ziv Hospital:
Propofol
Midazolam
sedation
cirrhosis
endoscopy
recovery time
efficacy and safety of sedation
patient satisfaction
return to baseline function
saturation of oxygen

Additional relevant MeSH terms:
Fibrosis
Pathologic Processes
Propofol
Midazolam
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Adjuvants, Anesthesia
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action