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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2009 by Federal University of São Paulo.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00906139
First Posted: May 21, 2009
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Federal University of São Paulo
  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
Intervention Model: Single Group Assignment
Masking: None (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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00906139


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

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
First Submitted: May 20, 2009
First Posted: May 21, 2009
Last Update Posted: October 12, 2017
Last Verified: May 2009

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

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