Evaluation of Bacterial and Fungal Contamination During Propofol Continuous Infusion

Not Applicable

• Conditions: Drug Contamination
• Interventions: Other: Re-filling of syringe with propofol without EDTA; Other: Target controlled infusion of propofol without EDTA; Drug: EDTA without re-filling; Other: Propofol syringe re-filling with propofol containing EDTA

• Registration Number: NCT00757458
• Lead Sponsor: University of Sao Paulo

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2008-09
• Study First Submitted: 2008-09-22
• Study First Submitted QC: 2008-09-22
• Last Update Submitted: 2008-09-22
• Study First Posted: 2008-09-23
• Last Update Posted: 2008-09-23
• Study Start: 2008-12
• Primary Completion: 2009-06
• Study Completion: 2009-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 652

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
3	Re-filling of syringe with propofol without EDTA	Re-filling of propofol syringe (Diprivan®-Astra Zeneca) with propofol without EDTA
4	Target controlled infusion of propofol without EDTA	Target controlled infusion of propofol without EDTA
1	EDTA without re-filling	TCI with EDTA
2	Propofol syringe re-filling with propofol containing EDTA	Re-filling of propofol syringe (Diprivan®-Astra Zeneca) with propofol containing EDTA

Primary Outcome Measures

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

Trial Locations

Locations (1)

Universidade de Sao Paulo Hospital das Clinicas; 🇧🇷 Sao Paulo, Brazil