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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified May 2009 by Federal University of São Paulo.
Recruitment status was Active, not recruiting

Sponsor:

Information provided by:

Federal University of São Paulo

ClinicalTrials.gov Identifier:

NCT00906139

First received: May 20, 2009

Last updated: May 22, 2009

Last verified: May 2009

History of Changes

Tracking Information
First Received Date ^ICMJE	May 20, 2009
Last Updated Date	May 22, 2009
Start Date ^ICMJE	March 2008
Estimated Primary Completion Date	February 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: May 20, 2009)	To compare propofol and fentanyl versus midazolam and fentanyl regarding safety and efficiency [ Time Frame: Three months ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00906139 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Propofol and Fentanyl Versus Midazolam and Fentanyl for Endoscopy Sedation in Cirrhotic Patients
Official Title ^ICMJE	Propofol and Fentanyl Versus Midazolam and Fentanyl for Sedation During Diagnostic or Therapeutic Gastrointestinal Endoscopy in Cirrhotic Patients
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.
Study Type ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Cirrhosis
Intervention ^ICMJE	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
Study Arm (s)	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
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Enrollment ^ICMJE	210
Estimated Completion Date	November 2009
Estimated Primary Completion Date	February 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 75 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Brazil

Administrative Information
NCT Number ^ICMJE	NCT00906139
Other Study ID Numbers ^ICMJE	LCorreia
Has Data Monitoring Committee	Yes
Responsible Party	Lucianna Pereira da Motta Pires Correia, Federal University of São Paulo
Study Sponsor ^ICMJE	Federal University of São Paulo
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Federal University of São Paulo
Verification Date	May 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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