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

Federal University of São Paulo

Status and phase: Unknown; Phase 4

Conditions: Cirrhosis

Treatments: Drug: Propofol; Drug: Fentanyl; Drug: Midazolam

Study type: Interventional

Funder types: Other

Identifiers

NCT00906139

LCorreia

Details and patient eligibility

About

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.

Full 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.

Enrollment: 210 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

210 participants in 2 patient groups

Propofol

Active Comparator group

Description:

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

Treatment:

Drug: Propofol

Drug: Fentanyl

Midazolam

Active Comparator group

Description:

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

Treatment:

Drug: Midazolam

Drug: Fentanyl