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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

June 8, 2010
June 9, 2010
July 2008
January 2009   (final data collection date for primary outcome measure)
Exacerbation of hepatic encephalopathy [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01141036 on ClinicalTrials.gov Archive Site
Recovery time, time to discharge [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Propofol Versus Midazolam for Upper Endoscopy in Cirrhotic Patients
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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
Cirrhosis
  • 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.
  • 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
  • Active Comparator: propofol
    propofol
    Intervention: Drug: propofol
  • Active Comparator: Midazolam
    Midazolam
    Intervention: Drug: Midazolam
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
February 2009
January 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT01141036
006-08, 006-08ziv
Yes
Liver Clinic, Ziv medical center
Ziv Hospital
Not Provided
Not Provided
Ziv Hospital
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP