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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00906139

Enrollment

210

Registered

2009-05-21

Start date

2008-03-31

Completion date

2009-11-30

Last updated

2009-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cirrhosis

Keywords

Propofol, Midazolam, Cirrhosis, Gastrointestinal endoscopy, Complications, Sedation

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.

Interventions

DRUGPropofol

Propofol dose: 0.5 mg/kg up to 400 mg

DRUGMidazolam

Midazolam dose: 0.1 mg/kg

DRUGFentanyl

Fentanyl dose: 0.05 mg

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame
To compare propofol and fentanyl versus midazolam and fentanyl regarding safety and efficiency	Three months

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026