Status:

UNKNOWN

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

Lead Sponsor:

Federal University of São Paulo

Conditions:

Cirrhosis

Eligibility:

All Genders

18-75 years

Phase:

PHASE4

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 cirrhoti...

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...

Eligibility Criteria

Inclusion

  • 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

  • Schistosomiasis
  • Recuse
  • Hepatocellular carcinoma
  • Contraindications to drugs
  • ASA IV or V
  • Hepatic encephalopathy, neurologic diseases
  • Opioids, narcotics, MAO inhibitors or benzodiazepines use
  • Alcohol abuse

Key Trial Info

Start Date :

March 1 2008

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

November 1 2009

Estimated Enrollment :

210 Patients enrolled

Trial Details

Trial ID

NCT00906139

Start Date

March 1 2008

End Date

November 1 2009

Last Update

May 25 2009

Active Locations (1)

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1

Federal University of São Paulo

São Paulo, São Paulo, Brazil, 04024-002