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

S

Soroka University Medical Center

Status

Unknown

Conditions

Liver Cirrhosis

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT00978978
SOR484909CTIL

Details and patient eligibility

About

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.

Enrollment

60 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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)

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

Trial design

60 participants in 2 patient groups

Propofol, endoscopies, liver diseases
Active Comparator group
Description:
Propofol, endoscopies, liver diseases
Treatment:
Drug: Propofol VS. midazolam and fentanyl, endoscopies, liver diseases
midazolam and fentanyl, endoscopies, liver diseases
Active Comparator group
Description:
Control: midazolam and fentanyl, endoscopies, liver diseases
Treatment:
Drug: Propofol VS. midazolam and fentanyl, endoscopies, liver diseases

Trial contacts and locations

1

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Central trial contact

Jorge-Shmuel Delgado, MD

Data sourced from clinicaltrials.gov

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