Propofol and Fentanyl Versus Midazolam and Fentanyl for Endoscopy Sedation in Cirrhotic Patients
This trial is active, not recruiting.
|Treatments||propofol, midazolam, fentanyl|
|Sponsor||Federal University of São Paulo|
|Start date||March 2008|
|End date||February 2009|
|Trial size||210 participants|
|Trial identifier||NCT00906139, LCorreia|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
To compare propofol and fentanyl versus midazolam and fentanyl regarding safety and efficiency
time frame: Three months
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
|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.|
Call for more information