Evaluation of Bacterial and Fungal Contamination During Propofol Continuous Infusion

University of Sao Paulo

Status: Unknown

Conditions: Drug Contamination

Treatments: Other: Re-filling of syringe with propofol without EDTA; Other: Target controlled infusion of propofol without EDTA; Other: Propofol syringe re-filling with propofol containing EDTA; Drug: EDTA without re-filling

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00757458

EDTA-652

Details and patient eligibility

About

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.

Enrollment: 652 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

652 participants in 4 patient groups

1

Active Comparator group

Description:

TCI with EDTA

Treatment:

Drug: EDTA without re-filling

2

Active Comparator group

Description:

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

Treatment:

Other: Propofol syringe re-filling with propofol containing EDTA

3

Active Comparator group

Description:

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

Treatment:

Other: Re-filling of syringe with propofol without EDTA

4

Active Comparator group

Description:

Target controlled infusion of propofol without EDTA

Treatment:

Other: Target controlled infusion of propofol without EDTA