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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00757458

Enrollment

652

Registered

2008-09-23

Start date

2008-12-31

Completion date

2009-12-31

Last updated

2008-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Drug Contamination

Keywords

Propofol, Bacterial growth, Fungal growth, EDTA, Target controlled infusion

Brief 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.

Interventions

DRUGEDTA without re-filling

Target controlled infusion of propofol containing EDTA (Diprivan®-Astra Zeneca) using equipment Diprifusor® (Astra Zeneca), without re-filling of syringe.

OTHERPropofol 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.

OTHERTarget controlled infusion of propofol without EDTA

Target controlled infusion of propofol without EDTA using Marshal´s technic with Alaris® or Fresenius® equipment

OTHERRe-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.

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Countries

Brazil

Contacts

Primary ContactMaria Jose C Carmona, Professor

maria.carmona@incor.usp.br55-11-3069-5367

Backup ContactJose Otavio C Auler Jr, Full Professor

auler@hcnet.usp.br55-11-3069-5232

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026