Propofol and Remifentanyl Versus Midazolam and Fentanyl for Diagnostic Colonoscopy in Patients With Compensated Cirrhosis Child A-B

Propofol and Remifentanyl Versus Midazolam and Fentanyl for Diagnostic Colonoscopy in Patients With Compensated Cirrhosis Child A-B

Sponsors

Lead sponsor: Ziv Hospital

Source Ziv Hospital
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.

Overall Status Unknown status
Start Date August 2011
Completion Date February 2012
Primary Completion Date February 2012
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Safety and efficacy of propofol in liver diseases up to 3 hours
Enrollment 90
Condition
Intervention

Intervention type: Drug

Intervention name: Propofol and Remifentnyl

Description: Intervention group (Propofol and remifentanyl): It will be administered under direct gastroenterologists' and hepatologist

Arm group label: Propofol and Remifentanyl

Intervention type: Drug

Intervention name: midazolam and fentanyl

Description: Intervention group (Propofol and fentanyl ): It will be administered under direct gastroenterologists'and hepatologist

Arm group label: midazolam and fentanyl

Intervention type: Drug

Intervention name: midazolam anf fentanyl

Description: group (Midazolam with Fentanyl): Both drugs will be administered by the gastroenterologists and/ or hepatologist and/ or anesthiologist

Arm group label: control midazolam anf fentanyl

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

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Overall Contact

Last name: Assy Nimer, MD

Phone: +97246828445

Email: [email protected]

Location
facility contact Ziv medical center liver unit Nimer Assy, MD +972-46828445 [email protected]
Location Countries

Israel

Verification Date

June 2010

Responsible Party

Name title: Liver Clinic

Organization: Ziv medical center

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Arm group label: Propofol and Remifentanyl

Arm group type: Active Comparator

Description: Propofol, colonoscopies, liver diseases, cirrhosis

Arm group label: midazolam and fentanyl

Arm group type: Active Comparator

Description: midazolam and fentanyl, colonoscopies, liver diseases

Arm group label: control midazolam anf fentanyl

Arm group type: Experimental

Description: midazolam anf fentanyl

Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Single (Participant)

Source: ClinicalTrials.gov