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

NCT ID: NCT00906139

Last Updated: 2009-05-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

210 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2009-11-30

Brief Summary

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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

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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.

Conditions

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Cirrhosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Propofol

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

Group Type ACTIVE_COMPARATOR

Propofol

Intervention Type DRUG

Propofol dose: 0.5 mg/kg up to 400 mg

Fentanyl

Intervention Type DRUG

Fentanyl dose: 0.05 mg

Midazolam

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

Group Type ACTIVE_COMPARATOR

Midazolam

Intervention Type DRUG

Midazolam dose: 0.1 mg/kg

Fentanyl

Intervention Type DRUG

Fentanyl dose: 0.05 mg

Interventions

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Propofol

Propofol dose: 0.5 mg/kg up to 400 mg

Intervention Type DRUG

Midazolam

Midazolam dose: 0.1 mg/kg

Intervention Type DRUG

Fentanyl

Fentanyl dose: 0.05 mg

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Federal University of São Paulo

OTHER

Sponsor Role lead

Responsible Party

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Federal University of São Paulo

Locations

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Federal University of São Paulo

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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LCorreia

Identifier Type: -

Identifier Source: org_study_id

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