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

Ziv Hospital

Status: Unknown

Conditions: Liver Disease

Treatments: Drug: midazolam anf fentanyl; Drug: Propofol and Remifentnyl; Drug: midazolam and fentanyl

Study type: Interventional

Funder types: Other

Identifiers

NCT01148277

Propofol vs Midazolam

Details and patient eligibility

About

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.

Enrollment: 90 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 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

90 participants in 3 patient groups

Propofol and Remifentanyl

Active Comparator group

Description:

Propofol, colonoscopies, liver diseases, cirrhosis

Treatment:

Drug: Propofol and Remifentnyl

midazolam and fentanyl

Active Comparator group

Description:

midazolam and fentanyl, colonoscopies, liver diseases

Treatment:

Drug: midazolam and fentanyl

control midazolam anf fentanyl

Experimental group

Description:

midazolam anf fentanyl

Treatment:

Drug: midazolam anf fentanyl