Evaluation of Bacterial and Fungal Contamination During Propofol Continuous Infusion
NCT ID: NCT00757458
Last Updated: 2008-09-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
652 participants
INTERVENTIONAL
2008-12-31
2009-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
SINGLE_GROUP
DOUBLE
Study Groups
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1
TCI with EDTA
EDTA without re-filling
Target controlled infusion of propofol containing EDTA (Diprivan®-Astra Zeneca) using equipment Diprifusor® (Astra Zeneca), without re-filling of syringe.
2
Re-filling of propofol syringe (Diprivan®-Astra Zeneca) with propofol containing EDTA
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.
3
Re-filling of propofol syringe (Diprivan®-Astra Zeneca) with propofol without EDTA
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.
4
Target controlled infusion of propofol without EDTA
Target controlled infusion of propofol without EDTA
Target controlled infusion of propofol without EDTA using Marshal´s technic with Alaris® or Fresenius® equipment
Interventions
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EDTA without re-filling
Target controlled infusion of propofol containing EDTA (Diprivan®-Astra Zeneca) using equipment Diprifusor® (Astra Zeneca), without re-filling of syringe.
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.
Target controlled infusion of propofol without EDTA
Target controlled infusion of propofol without EDTA using Marshal´s technic with Alaris® or Fresenius® equipment
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.
Eligibility Criteria
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Inclusion Criteria
* ASA Physiological Status P1 ou P2
* Patients undergoing clean procedure under general anesthesia.
Exclusion Criteria
* ASA Physiological Status P3, P4 or P5
* Current infectious process
18 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
University of Sao Paulo
OTHER
Responsible Party
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Universidade de Sao Paulo
Locations
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Universidade de Sao Paulo Hospital das Clinicas
São Paulo, São Paulo, Brazil
Countries
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Central Contacts
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Jose Otavio C Auler Jr, Full Professor
Role: CONTACT
Phone: 55-11-3069-5232
Email: [email protected]
References
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Jansson JR, Fukada T, Ozaki M, Kimura S. Propofol EDTA and reduced incidence of infection. Anaesth Intensive Care. 2006 Jun;34(3):362-8. doi: 10.1177/0310057X0603400305.
Fukada T, Ozaki M. Microbial growth in propofol formulations with disodium edetate and the influence of venous access system dead space. Anaesthesia. 2007 Jun;62(6):575-80. doi: 10.1111/j.1365-2044.2007.05002.x.
Trepanier CA, Lessard MR. Propofol and the risk of transmission of infection. Can J Anaesth. 2003 Jun-Jul;50(6):533-7. doi: 10.1007/BF03018635. No abstract available. English, French.
Bennett SN, McNeil MM, Bland LA, Arduino MJ, Villarino ME, Perrotta DM, Burwen DR, Welbel SF, Pegues DA, Stroud L, et al. Postoperative infections traced to contamination of an intravenous anesthetic, propofol. N Engl J Med. 1995 Jul 20;333(3):147-54. doi: 10.1056/NEJM199507203330303.
Other Identifiers
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EDTA-652
Identifier Type: -
Identifier Source: org_study_id