Propofol and Fentanyl Versus Midazolam and Fentanyl for Endoscopy Sedation in Cirrhotic Patients
NCT00906139 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 210
Last updated 2009-05-25
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.
Conditions
- Cirrhosis
Interventions
- DRUG
-
Propofol
Propofol dose: 0.5 mg/kg up to 400 mg
- DRUG
-
Midazolam
Midazolam dose: 0.1 mg/kg
- DRUG
-
Fentanyl dose: 0.05 mg
Sponsors & Collaborators
-
Federal University of São Paulo
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2008-03-31
- Primary Completion
- 2009-02-28
- Completion
- 2009-11-30
Countries
- Brazil
Study Locations
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