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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2009 by Federal University of São Paulo.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT00906139
First received: May 20, 2009
Last updated: May 22, 2009
Last verified: May 2009
  Purpose

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.


Condition Intervention Phase
Cirrhosis
Drug: Propofol
Drug: Midazolam
Drug: Fentanyl
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Propofol and Fentanyl Versus Midazolam and Fentanyl for Sedation During Diagnostic or Therapeutic Gastrointestinal Endoscopy in Cirrhotic Patients

Resource links provided by NLM:


Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:
  • To compare propofol and fentanyl versus midazolam and fentanyl regarding safety and efficiency [ Time Frame: Three months ] [ Designated as safety issue: Yes ]

Enrollment: 210
Study Start Date: March 2008
Estimated Study Completion Date: November 2009
Estimated Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Propofol
To receive propofol (0.5 mg/kg up to 400 mg) and fentanyl (0.05 mg);
Drug: Propofol
Propofol dose: 0.5 mg/kg up to 400 mg
Drug: Fentanyl
Fentanyl dose: 0.05 mg
Active Comparator: Midazolam
To receive midazolam (0.1 mg/kg) and fentanyl (0.05 mg).
Drug: Midazolam
Midazolam dose: 0.1 mg/kg
Drug: Fentanyl
Fentanyl dose: 0.05 mg

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00906139

Locations
Brazil
Federal University of São Paulo
São Paulo, Brazil, 04024-002
Sponsors and Collaborators
Federal University of São Paulo
  More Information

No publications provided

Responsible Party: Lucianna Pereira da Motta Pires Correia, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT00906139     History of Changes
Other Study ID Numbers: LCorreia
Study First Received: May 20, 2009
Last Updated: May 22, 2009
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by Federal University of São Paulo:
Propofol
Midazolam
Cirrhosis
Gastrointestinal endoscopy
Complications
Sedation

Additional relevant MeSH terms:
Liver Cirrhosis
Fibrosis
Liver Diseases
Digestive System Diseases
Pathologic Processes
Midazolam
Fentanyl
Propofol
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Opioid

ClinicalTrials.gov processed this record on July 20, 2014