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

Phase 4

• Conditions: Cirrhosis
• Interventions: Drug: Propofol; Drug: Midazolam; Drug: Fentanyl

• Registration Number: NCT00906139
• Lead Sponsor: Federal University of São Paulo

Brief Summary

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

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.

Study Timeline

• Study Start: 2008-03
• Primary Completion: 2009-02
• Status Verified: 2009-05
• Study First Submitted: 2009-05-20
• Study First Submitted QC: 2009-05-20
• Study First Posted: 2009-05-21
• Last Update Submitted: 2009-05-22
• Last Update Posted: 2009-05-25
• Study Completion: 2009-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 210

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Propofol	Fentanyl	To receive propofol (0.5 mg/kg up to 400 mg) and fentanyl (0.05 mg);
Propofol	Propofol	To receive propofol (0.5 mg/kg up to 400 mg) and fentanyl (0.05 mg);
Midazolam	Midazolam	To receive midazolam (0.1 mg/kg) and fentanyl (0.05 mg).
Midazolam	Fentanyl	To receive midazolam (0.1 mg/kg) and fentanyl (0.05 mg).

Primary Outcome Measures

Name	Time	Method
To compare propofol and fentanyl versus midazolam and fentanyl regarding safety and efficiency	Three months

Trial Locations

Locations (1)

Federal University of São Paulo; 🇧🇷 São Paulo, Brazil