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Propofol Versus Midazolam for Upper Endoscopy in Cirrhotic Patients

This study has been completed.
Sponsor:
Information provided by:
Ziv Hospital
ClinicalTrials.gov Identifier:
NCT01141036
First received: June 8, 2010
Last updated: June 9, 2010
Last verified: June 2010
  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 Blind (Subject)
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 [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Recovery time, time to discharge [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01141036

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

No publications provided

Responsible Party: Liver Clinic, Ziv medical center
ClinicalTrials.gov Identifier: NCT01141036     History of Changes
Other Study ID Numbers: 006-08, 006-08ziv
Study First Received: June 8, 2010
Last Updated: June 9, 2010
Health Authority: Israel: Ministry of Health

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:
Midazolam
Propofol
Adjuvants, Anesthesia
Anesthetics
Anesthetics, General
Anesthetics, Intravenous
Anti-Anxiety Agents
Central Nervous System Agents
Central Nervous System Depressants
GABA Agents
GABA Modulators
Hypnotics and Sedatives
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on November 25, 2014