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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2009 by Federal University of São Paulo.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00906139
First Posted: May 21, 2009
Last Update Posted: May 25, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Federal University of São Paulo
May 20, 2009
May 21, 2009
May 25, 2009
March 2008
February 2009   (Final data collection date for primary outcome measure)
To compare propofol and fentanyl versus midazolam and fentanyl regarding safety and efficiency [ Time Frame: Three months ]
Same as current
Complete list of historical versions of study NCT00906139 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Propofol and Fentanyl Versus Midazolam and Fentanyl for Endoscopy Sedation in Cirrhotic Patients
Propofol and Fentanyl Versus Midazolam and Fentanyl for Sedation During Diagnostic or Therapeutic Gastrointestinal Endoscopy in Cirrhotic Patients
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.
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.
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Cirrhosis
  • Drug: Propofol
    Propofol dose: 0.5 mg/kg up to 400 mg
  • Drug: Midazolam
    Midazolam dose: 0.1 mg/kg
  • Drug: Fentanyl
    Fentanyl dose: 0.05 mg
  • Active Comparator: Propofol
    To receive propofol (0.5 mg/kg up to 400 mg) and fentanyl (0.05 mg);
    Interventions:
    • Drug: Propofol
    • Drug: Fentanyl
  • Active Comparator: Midazolam
    To receive midazolam (0.1 mg/kg) and fentanyl (0.05 mg).
    Interventions:
    • Drug: Midazolam
    • Drug: Fentanyl
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
210
November 2009
February 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
 
NCT00906139
LCorreia
Yes
Not Provided
Not Provided
Lucianna Pereira da Motta Pires Correia, Federal University of São Paulo
Federal University of São Paulo
Not Provided
Not Provided
Federal University of São Paulo
May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP