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

Study Overview
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Brief Summary
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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.

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

Conditions
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Liver Disease

Intervention / Treatment
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* Drug: Propofol and Remifentnyl
* Drug: midazolam and fentanyl
* Drug: midazolam anf fentanyl


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Propofol and Remifentanyl<br>Propofol, colonoscopies, liver diseases, cirrhosis | Drug: Propofol and Remifentnyl<br>* Intervention group (Propofol and remifentanyl): It will be administered under direct gastroenterologists' and hepatologist<br>|
| Active Comparator: midazolam and fentanyl<br>midazolam and fentanyl, colonoscopies, liver diseases | Drug: midazolam and fentanyl<br>* Intervention group (Propofol and fentanyl ): It will be administered under direct gastroenterologists'and hepatologist<br>|
| Experimental: control midazolam anf fentanyl<br>midazolam anf fentanyl | Drug: midazolam anf fentanyl<br>* group (Midazolam with Fentanyl): Both drugs will be administered by the gastroenterologists and/ or hepatologist and/ or anesthiologist<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endoscopies, Liver diseases, Propofol, Midazolam and remifentanyl