ClinicalTrials.gov
ClinicalTrials.gov Menu

Evaluation of Bacterial and Fungal Contamination During Propofol Continuous Infusion

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.
ClinicalTrials.gov Identifier: NCT00757458
Recruitment Status : Unknown
Verified September 2008 by University of Sao Paulo.
Recruitment status was:  Not yet recruiting
First Posted : September 23, 2008
Last Update Posted : September 23, 2008
Sponsor:
Collaborator:
AstraZeneca
Information provided by:
University of Sao Paulo

Brief Summary:
The purpose of this study is to verify the existence of bacterial and/or fungal contamination during different technics of propofol with or without EDTA continuous infusion in patients undergoing general anesthesia.

Condition or disease Intervention/treatment Phase
Drug Contamination Drug: EDTA without re-filling Other: Propofol syringe re-filling with propofol containing EDTA Other: Target controlled infusion of propofol without EDTA Other: Re-filling of syringe with propofol without EDTA Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 652 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Official Title: Evaluation of Bacterial and Fungal Contamination During Propofol Continuous Infusion in Patients Undergoing General Anesthesia
Study Start Date : December 2008
Estimated Primary Completion Date : June 2009
Estimated Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Molds
Drug Information available for: Propofol

Arm Intervention/treatment
Active Comparator: 1
TCI with EDTA
Drug: EDTA without re-filling
Target controlled infusion of propofol containing EDTA (Diprivan®-Astra Zeneca) using equipment Diprifusor® (Astra Zeneca), without re-filling of syringe.

Active Comparator: 2
Re-filling of propofol syringe (Diprivan®-Astra Zeneca) with propofol containing EDTA
Other: Propofol syringe re-filling with propofol containing EDTA
Target controlled infusion of propofol (Diprivan®-Astra Zeneca) using equipment Diprifusor® (Astra Zeneca) with re-filling of syringe with propofol containing EDTA.

Active Comparator: 3
Re-filling of propofol syringe (Diprivan®-Astra Zeneca) with propofol without EDTA
Other: Re-filling of syringe with propofol without EDTA
Target controlled infusion of propofol (Diprivan®-Astra Zeneca) using equipment Diprifusor® (Astra Zeneca) with re-filling of syringe with propofol not containing EDTA.

Active Comparator: 4
Target controlled infusion of propofol without EDTA
Other: Target controlled infusion of propofol without EDTA
Target controlled infusion of propofol without EDTA using Marshal´s technic with Alaris® or Fresenius® equipment




Primary Outcome Measures :
  1. Existence of bacterial and/or fungal contamination during different technics of propofol continuous infusion [ Time Frame: 6 months ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age eighteen years old or more
  • ASA Physiological Status P1 ou P2
  • Patients undergoing clean procedure under general anesthesia.

Exclusion Criteria:

  • Patients under eighteen years old
  • ASA Physiological Status P3, P4 or P5
  • Current infectious process

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): NCT00757458


Contacts
Contact: Maria Jose C Carmona, Professor 55-11-3069-5367 maria.carmona@incor.usp.br
Contact: Jose Otavio C Auler Jr, Full Professor 55-11-3069-5232 auler@hcnet.usp.br

Locations
Brazil
Universidade de Sao Paulo Hospital das Clinicas
Sao Paulo, Brazil, 05403-000
Sponsors and Collaborators
University of Sao Paulo
AstraZeneca

Publications:
Responsible Party: Jose Otavio Costa Auler Jr. / Full Professor Department of Anesthesiology, Universidade de Sao Paulo
ClinicalTrials.gov Identifier: NCT00757458     History of Changes
Other Study ID Numbers: EDTA-652
First Posted: September 23, 2008    Key Record Dates
Last Update Posted: September 23, 2008
Last Verified: September 2008

Keywords provided by University of Sao Paulo:
Propofol
Bacterial growth
Fungal growth
EDTA
Target controlled infusion

Additional relevant MeSH terms:
Propofol
Edetic Acid
Pentetic Acid
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Antidotes
Protective Agents
Iron Chelating Agents