Overview

This trial is active, not recruiting.

Condition cirrhosis
Treatments propofol, midazolam, fentanyl
Phase phase 4
Sponsor Federal University of São Paulo
Start date March 2008
End date February 2009
Trial size 210 participants
Trial identifier NCT00906139, LCorreia

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
To receive propofol (0.5 mg/kg up to 400 mg) and fentanyl (0.05 mg);
propofol
Propofol dose: 0.5 mg/kg up to 400 mg
fentanyl
Fentanyl dose: 0.05 mg
(Active Comparator)
To receive midazolam (0.1 mg/kg) and fentanyl (0.05 mg).
midazolam
Midazolam dose: 0.1 mg/kg
fentanyl
Fentanyl dose: 0.05 mg

Primary Outcomes

Measure
To compare propofol and fentanyl versus midazolam and fentanyl regarding safety and efficiency
time frame: Three months

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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

Additional Information

Official title Propofol and Fentanyl Versus Midazolam and Fentanyl for Sedation During Diagnostic or Therapeutic Gastrointestinal Endoscopy in Cirrhotic Patients
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2009.
Information provided to ClinicalTrials.gov by Federal University of São Paulo.