Back to resultsPropofol and Remifentanyl Versus Midazolam and Fentanyl for Diagnostic Colonoscopy in Patients With Compensated Cirrhosis Child A-B
Primary Purpose
Liver Disease
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Propofol and Remifentnyl
midazolam and fentanyl
midazolam anf fentanyl
Sponsored by
About this trial
This is an interventional treatment trial for Liver Disease focused on measuring Endoscopies, Liver diseases, Propofol, Midazolam and remifentanyl
Eligibility Criteria
Inclusion Criteria:
- Consecutive patients older than 18 and younger than 75 years with cirrhosis defined by the presence of liver fibrosis at least F3 and higher in the METAVIR score or with established cirrhosis (Child Pugh A, B)
Exclusion Criteria:
- Patients with significant cardiorespiratory disease i.e. advanced respiratory, renal and heart failure (ASA class III or higher except for patients with decompensate liver cirrhosis), obstructive sleep apnea.
- HCC
Sites / Locations
- Ziv medical center liver unit
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Experimental
Arm Label
Propofol and Remifentanyl
midazolam and fentanyl
control midazolam anf fentanyl
Arm Description
Propofol, colonoscopies, liver diseases, cirrhosis
midazolam and fentanyl, colonoscopies, liver diseases
midazolam anf fentanyl
Outcomes
Primary Outcome Measures
Safety and efficacy of propofol in liver diseases
At the end of each endoscopy
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01148277
Brief Title
Propofol and Remifentanyl Versus Midazolam and Fentanyl for Diagnostic Colonoscopy in Patients With Compensated Cirrhosis Child A-B
Official Title
Propofol and Remifentanyl Versus Midazolam and Fentanyl for Diagnostic Colonoscopy in Patients With Compensated Cirrhosis Child A-B
Study Type
Interventional
2. Study Status
Record Verification Date
June 2010
Overall Recruitment Status
Unknown status
Study Start Date
August 2011 (undefined)
Primary Completion Date
February 2012 (Anticipated)
Study Completion Date
February 2012 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Ziv Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a prospective, randomized-controlled trial (RCT) comparing the use of Propofol and Remifentanyl and traditional sedation (Midazolam and Fentanyl) for diagnostic colonoscopies in patients with compensated cirrhosis child A-B. The working hypothesis is that the use of propofol will be translated in a shorter recovery and discharge times with a higher patient satisfaction and a decrease in general complications (Hepatic Encephalopathy) in the context of patients with advanced liver disease.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Disease
Keywords
Endoscopies, Liver diseases, Propofol, Midazolam and remifentanyl
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Propofol and Remifentanyl
Arm Type
Active Comparator
Arm Description
Propofol, colonoscopies, liver diseases, cirrhosis
Arm Title
midazolam and fentanyl
Arm Type
Active Comparator
Arm Description
midazolam and fentanyl, colonoscopies, liver diseases
Arm Title
control midazolam anf fentanyl
Arm Type
Experimental
Arm Description
midazolam anf fentanyl
Intervention Type
Drug
Intervention Name(s)
Propofol and Remifentnyl
Intervention Description
Intervention group (Propofol and remifentanyl): It will be administered under direct gastroenterologists' and hepatologist
Intervention Type
Drug
Intervention Name(s)
midazolam and fentanyl
Intervention Description
Intervention group (Propofol and fentanyl ): It will be administered under direct gastroenterologists'and hepatologist
Intervention Type
Drug
Intervention Name(s)
midazolam anf fentanyl
Intervention Description
group (Midazolam with Fentanyl): Both drugs will be administered by the gastroenterologists and/ or hepatologist and/ or anesthiologist
Primary Outcome Measure Information:
Title
Safety and efficacy of propofol in liver diseases
Description
At the end of each endoscopy
Time Frame
up to 3 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Consecutive patients older than 18 and younger than 75 years with cirrhosis defined by the presence of liver fibrosis at least F3 and higher in the METAVIR score or with established cirrhosis (Child Pugh A, B)
Exclusion Criteria:
Patients with significant cardiorespiratory disease i.e. advanced respiratory, renal and heart failure (ASA class III or higher except for patients with decompensate liver cirrhosis), obstructive sleep apnea.
HCC
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Assy Nimer, MD
Phone
+97246828445
Email
ASSY.N@ZIV.HEALTH.GOV.IL
Facility Information:
Facility Name
Ziv medical center liver unit
City
Safed, Israel
ZIP/Postal Code
13100
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nimer Assy, MD
Phone
+972-46828445
Email
assy.n@ziv.health.gov.il
12. IPD Sharing Statement
Learn more about this trial
Propofol and Remifentanyl Versus Midazolam and Fentanyl for Diagnostic Colonoscopy in Patients With Compensated Cirrhosis Child A-B
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