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

Primary Purpose

Cirrhosis

Status
Unknown status
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Propofol
Midazolam
Fentanyl
Sponsored by
Federal University of São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cirrhosis focused on measuring Propofol, Midazolam, Cirrhosis, Gastrointestinal endoscopy, Complications, Sedation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Federal University of São Paulo

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Propofol

Midazolam

Arm Description

To receive propofol (0.5 mg/kg up to 400 mg) and fentanyl (0.05 mg);

To receive midazolam (0.1 mg/kg) and fentanyl (0.05 mg).

Outcomes

Primary Outcome Measures

To compare propofol and fentanyl versus midazolam and fentanyl regarding safety and efficiency

Secondary Outcome Measures

Full Information

First Posted
May 20, 2009
Last Updated
May 22, 2009
Sponsor
Federal University of São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT00906139
Brief Title
Propofol and Fentanyl Versus Midazolam and Fentanyl for Endoscopy Sedation in Cirrhotic Patients
Official Title
Propofol and Fentanyl Versus Midazolam and Fentanyl for Sedation During Diagnostic or Therapeutic Gastrointestinal Endoscopy in Cirrhotic Patients
Study Type
Interventional

2. Study Status

Record Verification Date
May 2009
Overall Recruitment Status
Unknown status
Study Start Date
March 2008 (undefined)
Primary Completion Date
February 2009 (Anticipated)
Study Completion Date
November 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Federal University of São Paulo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cirrhosis
Keywords
Propofol, Midazolam, Cirrhosis, Gastrointestinal endoscopy, Complications, Sedation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
210 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Propofol
Arm Type
Active Comparator
Arm Description
To receive propofol (0.5 mg/kg up to 400 mg) and fentanyl (0.05 mg);
Arm Title
Midazolam
Arm Type
Active Comparator
Arm Description
To receive midazolam (0.1 mg/kg) and fentanyl (0.05 mg).
Intervention Type
Drug
Intervention Name(s)
Propofol
Intervention Description
Propofol dose: 0.5 mg/kg up to 400 mg
Intervention Type
Drug
Intervention Name(s)
Midazolam
Intervention Description
Midazolam dose: 0.1 mg/kg
Intervention Type
Drug
Intervention Name(s)
Fentanyl
Intervention Description
Fentanyl dose: 0.05 mg
Primary Outcome Measure Information:
Title
To compare propofol and fentanyl versus midazolam and fentanyl regarding safety and efficiency
Time Frame
Three months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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 Recuse Hepatocellular carcinoma Contraindications to drugs ASA IV or V Hepatic encephalopathy, neurologic diseases Opioids, narcotics, MAO inhibitors or benzodiazepines use Alcohol abuse
Facility Information:
Facility Name
Federal University of São Paulo
City
São Paulo
ZIP/Postal Code
04024-002
Country
Brazil

12. IPD Sharing Statement

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

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