Evaluation of Bacterial and Fungal Contamination During Propofol Continuous Infusion

Drug Contamination Clinical Trial

Official title:

Evaluation of Bacterial and Fungal Contamination During Propofol Continuous Infusion in Patients Undergoing General Anesthesia

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00757458
• Other study ID #: EDTA-652
• Status: Not yet recruiting
• Phase: N/A
• First received: September 22, 2008
• Last updated: September 22, 2008
• Start date: December 2008
• Est. completion date: December 2009

Study information

• Verified date: September 2008
• Source: University of Sao Paulo
• Contact: Maria Jose C Carmona, Professor
• Phone: 55-11-3069-5367
• Email: maria.carmona[@]incor.usp.br
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 652
• Est. completion date: December 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Drug Contamination

Intervention

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.

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.
• 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.

Locations

Country	Name	City	State
Brazil	Universidade de Sao Paulo Hospital das Clinicas	Sao Paulo

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo	AstraZeneca

Country where clinical trial is conducted

Brazil, 

References & Publications (4)

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. — View Citation

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. — View Citation

Jansson JR, Fukada T, Ozaki M, Kimura S. Propofol EDTA and reduced incidence of infection. Anaesth Intensive Care. 2006 Jun;34(3):362-8. Review. — View Citation

Trépanier CA, Lessard MR. Propofol and the risk of transmission of infection. Can J Anaesth. 2003 Jun-Jul;50(6):533-7. English, French. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Existence of bacterial and/or fungal contamination during different technics of propofol continuous infusion		6 months	Yes