Evaluation of Bacterial and Fungal Contamination During Propofol Continuous Infusion

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

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.

Study Overview

• Status: Unknown
• Conditions: Drug Contamination
• Intervention / Treatment: Drug: EDTA without re-filling; Other: Propofol syringe re-filling with propofol containing EDTA; Other: Re-filling of syringe with propofol without EDTA; Other: Target controlled infusion of propofol without EDTA

• Study Type: Interventional
• Enrollment (Anticipated): 652
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maria Jose C Carmona, Professor; Phone Number: 55-11-3069-5367; Email: maria.carmona@incor.usp.br
• Study Contact Backup: Name: Jose Otavio C Auler Jr, Full Professor; Phone Number: 55-11-3069-5232; Email: auler@hcnet.usp.br

Study Locations

• Brazil
  • Sao Paulo, Brazil, 05403-000
    • Universidade de Sao Paulo Hospital das Clinicas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: DOUBLE

Number of Arms

4

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Existence of bacterial and/or fungal contamination during different technics of propofol continuous infusion	6 months

Collaborators and Investigators

• Sponsor: University of Sao Paulo
• Collaborators: AstraZeneca

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2008
• Primary Completion (ANTICIPATED): June 1, 2009
• Study Completion (ANTICIPATED): December 1, 2009

Study Registration Dates

• First Submitted: September 22, 2008
• First Submitted That Met QC Criteria: September 22, 2008
• First Posted (ESTIMATE): September 23, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): September 23, 2008
• Last Update Submitted That Met QC Criteria: September 22, 2008
• Last Verified: September 1, 2008

More Information

Terms related to this study

• Keywords: Propofol; Target controlled infusion; EDTA; Fungal growth; Bacterial growth
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Protective Agents; Hypnotics and Sedatives; Anticoagulants; Antidotes; Chelating Agents; Sequestering Agents; Iron Chelating Agents; Calcium Chelating Agents; Propofol; Edetic Acid; Pentetic Acid
• Other Study ID Numbers: EDTA-652