Evaluation of Bacterial and Fungal Contamination During Propofol Continuous Infusion

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2008 by University of Sao Paulo.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
AstraZeneca
Information provided by:
University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT00757458
First received: September 22, 2008
Last updated: NA
Last verified: September 2008
History: No changes posted
  Purpose

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 Intervention
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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: Evaluation of Bacterial and Fungal Contamination During Propofol Continuous Infusion in Patients Undergoing General Anesthesia

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Existence of bacterial and/or fungal contamination during different technics of propofol continuous infusion [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 652
Study Start Date: December 2008
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  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: 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
  More Information

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
Study First Received: September 22, 2008
Last Updated: September 22, 2008
Health Authority: Brazil: National Committee of Ethics in Research

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

Additional relevant MeSH terms:
Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Intravenous
Anesthetics, General
Anesthetics

ClinicalTrials.gov processed this record on September 22, 2014