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Clinical Trials/NCT00757458
NCT00757458UnknownNot Applicable

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

University of Sao Paulo1 site in 1 country652 target enrollmentStarted: December 2008Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Enrollment
652
Locations
1
Primary Endpoint
Existence of bacterial and/or fungal contamination during different technics of propofol continuous infusion

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Single Group
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

1

Active Comparator

TCI with EDTA

Intervention: EDTA without re-filling (Drug)

2

Active Comparator

Re-filling of propofol syringe (Diprivan®-Astra Zeneca) with propofol containing EDTA

Intervention: Propofol syringe re-filling with propofol containing EDTA (Other)

3

Active Comparator

Re-filling of propofol syringe (Diprivan®-Astra Zeneca) with propofol without EDTA

Intervention: Re-filling of syringe with propofol without EDTA (Other)

4

Active Comparator

Target controlled infusion of propofol without EDTA

Intervention: Target controlled infusion of propofol without EDTA (Other)

Outcomes

Primary Outcomes

Existence of bacterial and/or fungal contamination during different technics of propofol continuous infusion

Time Frame: 6 months

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other

Study Sites (1)

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