Propofol and Fentanyl Versus Midazolam and Fentanyl for Sedation During Diagnostic or Therapeutic Gastrointestinal Endoscopy in Cirrhotic Patients
Overview
- Phase
- Phase 4
- Intervention
- Propofol
- Conditions
- Cirrhosis
- Sponsor
- Federal University of São Paulo
- Enrollment
- 210
- Locations
- 1
- Primary Endpoint
- To compare propofol and fentanyl versus midazolam and fentanyl regarding safety and efficiency
- Last Updated
- 16 years ago
Overview
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.
Investigators
Eligibility Criteria
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
- •Hepatocellular carcinoma
- •Contraindications to drugs
- •ASA IV or V
- •Hepatic encephalopathy, neurologic diseases
- •Opioids, narcotics, MAO inhibitors or benzodiazepines use
- •Alcohol abuse
Arms & Interventions
Propofol
To receive propofol (0.5 mg/kg up to 400 mg) and fentanyl (0.05 mg);
Intervention: Propofol
Propofol
To receive propofol (0.5 mg/kg up to 400 mg) and fentanyl (0.05 mg);
Intervention: Fentanyl
Midazolam
To receive midazolam (0.1 mg/kg) and fentanyl (0.05 mg).
Intervention: Midazolam
Midazolam
To receive midazolam (0.1 mg/kg) and fentanyl (0.05 mg).
Intervention: Fentanyl
Outcomes
Primary Outcomes
To compare propofol and fentanyl versus midazolam and fentanyl regarding safety and efficiency
Time Frame: Three months