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Evaluation of Bacterial and Fungal Contamination During Propofol Continuous Infusion

NCT00757458 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 652

Last updated 2008-09-23

No results posted yet for this study

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.

Conditions

  • Drug Contamination

Interventions

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.

OTHER

Target controlled infusion of propofol without EDTA

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

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.

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • University of Sao Paulo

    lead OTHER

Study Design

Allocation
RANDOMIZED
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-12-31
Primary Completion
2009-06-30
Completion
2009-12-31

Countries

  • Brazil

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00757458 on ClinicalTrials.gov