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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01148277

Enrollment

Registered

2010-06-22

Start date

2011-08-31

Completion date

2012-02-29

Last updated

2011-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Disease

Keywords

Endoscopies, Liver diseases, Propofol, Midazolam and remifentanyl

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.

Interventions

DRUGPropofol and Remifentnyl

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

DRUGmidazolam and fentanyl

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

DRUGmidazolam anf fentanyl

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Safety and efficacy of propofol in liver diseases	up to 3 hours	At the end of each endoscopy

Countries

Israel

Contacts

Primary ContactAssy Nimer, MD

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026