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Propofol Versus Midazolam for Upper Endoscopy in Cirrhotic Patients

Primary Purpose

Cirrhosis

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
propofol
Midazolam
Sponsored by
Ziv Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cirrhosis focused on measuring Propofol, Midazolam, sedation, cirrhosis, endoscopy, recovery time, efficacy and safety of sedation, patient satisfaction, return to baseline function, saturation of oxygen

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ziv medical center liver unit

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

propofol

Midazolam

Arm Description

propofol

Midazolam

Outcomes

Primary Outcome Measures

Exacerbation of hepatic encephalopathy

Secondary Outcome Measures

Recovery time, time to discharge

Full Information

First Posted
June 8, 2010
Last Updated
June 9, 2010
Sponsor
Ziv Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01141036
Brief Title
Propofol Versus Midazolam for Upper Endoscopy in Cirrhotic Patients
Official Title
Propofol Versus Midazolam for Upper Endoscopy in Cirrhotic Patients
Study Type
Interventional

2. Study Status

Record Verification Date
June 2010
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
February 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Ziv Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cirrhosis
Keywords
Propofol, Midazolam, sedation, cirrhosis, endoscopy, recovery time, efficacy and safety of sedation, patient satisfaction, return to baseline function, saturation of oxygen

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
propofol
Arm Type
Active Comparator
Arm Description
propofol
Arm Title
Midazolam
Arm Type
Active Comparator
Arm Description
Midazolam
Intervention Type
Drug
Intervention Name(s)
propofol
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Midazolam
Intervention Description
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
Primary Outcome Measure Information:
Title
Exacerbation of hepatic encephalopathy
Secondary Outcome Measure Information:
Title
Recovery time, time to discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Ziv medical center liver unit
City
Safed, Israel
ZIP/Postal Code
13100
Country
Israel

12. IPD Sharing Statement

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Propofol Versus Midazolam for Upper Endoscopy in Cirrhotic Patients

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