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

Liver Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01148277
• Other study ID #: Propofol vs Midazolam
• Status: Not yet recruiting
• Phase: N/A
• First received: June 13, 2010
• Last updated: April 5, 2011
• Start date: August 2011
• Est. completion date: February 2012

Study information

• Verified date: June 2010
• Source: Ziv Hospital
• Contact: Assy Nimer, MD
• Phone: +97246828445
• Email: ASSY.N[@]ZIV.HEALTH.GOV.IL
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Liver Cirrhosis
• Liver Disease
• Liver Diseases

Intervention

Drug:
• Propofol and Remifentnyl
Intervention group (Propofol and remifentanyl): It will be administered under direct gastroenterologists' and hepatologist
• midazolam and fentanyl
Intervention group (Propofol and fentanyl ): It will be administered under direct gastroenterologists'and hepatologist
• midazolam anf fentanyl
group (Midazolam with Fentanyl): Both drugs will be administered by the gastroenterologists and/ or hepatologist and/ or anesthiologist

Locations

Country	Name	City	State
Israel	Ziv medical center liver unit	Safed, Israel

Sponsors (1)

Lead Sponsor	Collaborator
Ziv Hospital

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and efficacy of propofol in liver diseases	At the end of each endoscopy	up to 3 hours	Yes