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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 17 October 2012
Main ID:  NCT00757458
Date of registration: 22/09/2008
Primary sponsor: University of Sao Paulo
Public title: Evaluation of Bacterial and Fungal Contamination During Propofol Continuous Infusion
Scientific title: Evaluation of Bacterial and Fungal Contamination During Propofol Continuous Infusion in Patients Undergoing General Anesthesia
Date of first enrolment: December 2008
Target sample size: 652
Recruitment status: Not yet recruiting
URL:  http://clinicaltrials.gov/show/NCT00757458
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator)  
Countries of recruitment
Brazil
Contacts
Name:   Maria Jose C Carmona, Professor
Address: 
Telephone: 55-11-3069-5367
Email: maria.carmona@incor.usp.br
Affiliation: 
Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Drug Contamination
Intervention(s)
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
Primary Outcome(s)
Existence of bacterial and/or fungal contamination during different technics of propofol continuous infusion [Time Frame: 6 months]
Secondary Outcome(s)
Secondary ID(s)
EDTA-652
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
AstraZeneca
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