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

NCT ID: NCT01148277

Last Updated: 2011-04-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2012-02-29

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.

Conditions

Liver Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Propofol and Remifentanyl

Propofol, colonoscopies, liver diseases, cirrhosis

Group Type: ACTIVE_COMPARATOR

Propofol and Remifentnyl

Intervention Type: DRUG

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

midazolam and fentanyl

midazolam and fentanyl, colonoscopies, liver diseases

Group Type: ACTIVE_COMPARATOR

midazolam and fentanyl

Intervention Type: DRUG

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

control midazolam anf fentanyl

midazolam anf fentanyl

Group Type: EXPERIMENTAL

midazolam anf fentanyl

Intervention Type: DRUG

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

Interventions

Propofol and Remifentnyl

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

Intervention Type: DRUG

midazolam and fentanyl

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

Intervention Type: DRUG

midazolam anf fentanyl

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ziv Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Ziv medical center

Locations

Ziv medical center liver unit

Safed, Israel, , Israel

Countries

Israel

Central Contacts

Assy Nimer, MD

Role: CONTACT

ASSY.N@ZIV.HEALTH.GOV.IL

+97246828445

Facility Contacts

Nimer Assy, MD

Role: primary

assy.n@ziv.health.gov.il

+972-46828445

Other Identifiers

Propofol vs Midazolam

Identifier Type: -

Identifier Source: org_study_id