Propofol and Fentanyl Versus Midazolam and Fentanyl for Endoscopy Sedation in Cirrhotic Patients

Study Overview
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Brief Summary
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The purpose of this study is to compare propofol associated with fentanyl versus midazolam plus fentanyl for sedation during diagnosis or therapeutic upper gastrointestinal endoscopy (UGE) in cirrhotic patients.

Detailed Description
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UGE is often performed in cirrhotic patients for the diagnosis and treatment of portal hypertension complications. Current data suggests that propofol sedation may have advantages over benzodiazepines. However, there are few reports comparing propofol versus midazolam in patients with liver cirrhosis. The study's objective is to compare propofol associated with fentanyl versus midazolam plus fentanyl for sedation during diagnosis or therapeutic UGE in cirrhotic patients. A prospective randomized study will include cirrhotic patients (Child A, B or C and ASA 2 or 3), referred for diagnostic or therapeutic UGE, randomized for group I: propofol (0,5 mg/kg up to 400 mg) and fentanyl (0,05 mg); or group II: midazolam (0,1 mg/kg) and fentanyl. Sedation was performed by an exclusively dedicated gastroenterologist. Efficacy (completion of procedures), complications (hypoxemia, hypotension, arrhythmias) and recovery time (elapsed from the end of the procedure and discharge) will be studied.

Official Title
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Propofol and Fentanyl Versus Midazolam and Fentanyl for Sedation During Diagnostic or Therapeutic Gastrointestinal Endoscopy in Cirrhotic Patients

Conditions
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Cirrhosis

Intervention / Treatment
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* Drug: Propofol
* Drug: Midazolam
* Drug: Fentanyl


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Liver cirrhosis, any etiology ASA II or III Child A, B or C Age between 18 years and 75 years Patients that agree in participate of study and signed the contentment term Exclusion Criteria: Schistosomiasis Recuse Hepatocellular carcinoma Contraindications to drugs ASA IV or V Hepatic encephalopathy, neurologic diseases Opioids, narcotics, MAO inhibitors or benzodiazepines use Alcohol abuse

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Propofol<br>To receive propofol (0.5 mg/kg up to 400 mg) and fentanyl (0.05 mg); | Drug: Propofol<br>* Propofol dose: 0.5 mg/kg up to 400 mg<br>Drug: Fentanyl<br>* Fentanyl dose: 0.05 mg<br>|
| Active Comparator: Midazolam<br>To receive midazolam (0.1 mg/kg) and fentanyl (0.05 mg). | Drug: Midazolam<br>* Midazolam dose: 0.1 mg/kg<br>Drug: Fentanyl<br>* Fentanyl dose: 0.05 mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare propofol and fentanyl versus midazolam and fentanyl regarding safety and efficiency |  | Three months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Propofol, Midazolam, Cirrhosis, Gastrointestinal endoscopy, Complications, Sedation