Evaluation of Bacterial and Fungal Contamination During Propofol Continuous Infusion

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00757458
• Date of registration: 22/09/2008
• Prospective Registration: Yes
• 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)
• Phase: N/A

Countries of recruitment

Brazil

Contacts

• Name: Maria Jose C Carmona, Professor

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: Target controlled infusion of propofol without EDTA

Other: Propofol syringe re-filling with propofol containing EDTA

Other: Re-filling of syringe with 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 ID(s)

EDTA-652

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

AstraZeneca