Propofol Versus Midazolam and Fentanyl for Diagnostic and Screening Colonoscopy in Patients With Advanced Liver Disease

NCT00978978 | Unknown

• 1 other identifier: SOR484909CTIL
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Prospective, randomized-controlled trial (RCT) comparing the use of Propofol and traditional sedation (Midazolam and Fentanyl) for diagnostic and screening endoscopies in patients with liver diseases. The investigators' 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 in the context of patients with advanced liver disease.

Conditions

Liver Cirrhosis

Outcome Measures

Primary Outcomes (1)

• Safety and efficacy of propofol in liver diseases

  At the end of each endoscopy

Study Arms (2)

Propofol, endoscopies, liver diseases

ACTIVE COMPARATOR

Propofol, endoscopies, liver diseases

Drug: Propofol VS. midazolam and fentanyl, endoscopies, liver diseases

midazolam and fentanyl, endoscopies, liver diseases

ACTIVE COMPARATOR

Control: midazolam and fentanyl, endoscopies, liver diseases

Drug: Propofol VS. midazolam and fentanyl, endoscopies, liver diseases

Interventions

Propofol VS. midazolam and fentanyl, endoscopies, liver diseases DRUG

1. Intervention group (Propofol): It will be administered as a monotherapy under direct gastroenterologists' 2. Control group (Midazolam with or without Fentanyl): Both drugs will be administered by the gastroenterologists

Propofol, endoscopies, liver diseases; midazolam and fentanyl, endoscopies, liver diseases

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 advanced liver disease, defined by the presence of liver fibrosis at least F3 and higher in the METAVIR score or with established cirrhosis (Child Pugh A, B and C)

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 or those with mild degree of liver fibrosis (less than F3)

Sponsors & Collaborators

• Soroka University Medical Center: lead

Study Sites (1)

Department of Gastroenterology. Soroka University Medical Center

Beersheba, Beer-Sheva, 84101, Israel

Location

MeSH Terms

Conditions

Liver Cirrhosis

Interventions

Fentanyl; Endoscopy

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Central Study Contacts

Jorge-Shmuel Delgado, MD

CONTACT

972-8-6403164; delgado@bgu.ac.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 16, 2009
• First Posted: September 17, 2009
• Study Start: October 1, 2009
• Primary Completion: August 1, 2010
• Last Updated: October 14, 2009

Record last verified: 2009-09

Locations

IL (1)