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

Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT00906139
• Other study ID #: LCorreia
• Status: Unknown status
• Phase: Phase 4
• First received: May 20, 2009
• Last updated: May 22, 2009
• Start date: March 2008
• Est. completion date: November 2009

Study information

• Verified date: May 2009
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 210
• Est. completion date: November 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cirrhosis
• Fibrosis

Intervention

Drug:
• Propofol
Propofol dose: 0.5 mg/kg up to 400 mg
• Midazolam
Midazolam dose: 0.1 mg/kg
• Fentanyl
Fentanyl dose: 0.05 mg

Locations

Country	Name	City	State
Brazil	Federal University of São Paulo	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To compare propofol and fentanyl versus midazolam and fentanyl regarding safety and efficiency		Three months