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

NCT01148277 | Unknown DMC

• 1 other identifier: Propofol vs Midazolam
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Keywords

Endoscopies; Liver diseases; Propofol; Midazolam and remifentanyl

Outcome Measures

Primary Outcomes (1)

• Safety and efficacy of propofol in liver diseases

  At the end of each endoscopy

  up to 3 hours

Study Arms (3)

Propofol and Remifentanyl

ACTIVE COMPARATOR

Propofol, colonoscopies, liver diseases, cirrhosis

Drug: Propofol and Remifentnyl

midazolam and fentanyl

ACTIVE COMPARATOR

midazolam and fentanyl, colonoscopies, liver diseases

Drug: midazolam and fentanyl

control midazolam anf fentanyl

EXPERIMENTAL

midazolam anf fentanyl

Drug: midazolam anf fentanyl

Interventions

Propofol and Remifentnyl DRUG

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

Propofol and Remifentanyl

midazolam and fentanyl DRUG

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

midazolam and fentanyl

midazolam anf fentanyl DRUG

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

control midazolam anf fentanyl

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Ziv Hospital: lead

Study Sites (1)

Ziv medical center liver unit

Safed, Israel, 13100, Israel

Location

MeSH Terms

Conditions

Liver Diseases

Interventions

Propofol; Midazolam; Fentanyl

Condition Hierarchy (Ancestors)

Digestive System Diseases

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Piperidines; Heterocyclic Compounds, 1-Ring

Central Study Contacts

Assy Nimer, MD

CONTACT

+97246828445; ASSY.N@ZIV.HEALTH.GOV.IL

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: June 13, 2010
• First Posted: June 22, 2010
• Study Start: August 1, 2011
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: April 6, 2011

Record last verified: 2010-06

Locations

IL (1)