Liver Cirrhosis
Conditions
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.
Interventions
DRUGPropofol VS. midazolam and fentanyl, endoscopies, liver diseases
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
Sponsors
Soroka University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
DOUBLE (Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and efficacy of propofol in liver diseases | At the end of each endoscopy |
Countries
Israel
Contacts
Primary ContactJorge-Shmuel Delgado, MD
Outcome results
None listed