Evaluation of Bacterial and Fungal Contamination During 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.

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

Conditions
-----------------
Drug Contamination

Intervention / Treatment
-----------------
* Drug: EDTA without re-filling
* Other: Propofol syringe re-filling with propofol containing EDTA
* Other: Target controlled infusion of propofol without EDTA
* Other: Re-filling of syringe with propofol without EDTA


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>TCI with EDTA | Drug: EDTA without re-filling<br>* Target controlled infusion of propofol containing EDTA (Diprivan®-Astra Zeneca) using equipment Diprifusor® (Astra Zeneca), without re-filling of syringe.<br>|
| Active Comparator: 2<br>Re-filling of propofol syringe (Diprivan®-Astra Zeneca) with propofol containing EDTA | Other: Propofol syringe re-filling with propofol containing EDTA<br>* Target controlled infusion of propofol (Diprivan®-Astra Zeneca) using equipment Diprifusor® (Astra Zeneca) with re-filling of syringe with propofol containing EDTA.<br>|
| Active Comparator: 3<br>Re-filling of propofol syringe (Diprivan®-Astra Zeneca) with propofol without EDTA | Other: Re-filling of syringe with propofol without EDTA<br>* Target controlled infusion of propofol (Diprivan®-Astra Zeneca) using equipment Diprifusor® (Astra Zeneca) with re-filling of syringe with propofol not containing EDTA.<br>|
| Active Comparator: 4<br>Target controlled infusion of propofol without EDTA | Other: Target controlled infusion of propofol without EDTA<br>* Target controlled infusion of propofol without EDTA using Marshal´s technic with Alaris® or Fresenius® equipment<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Existence of bacterial and/or fungal contamination during different technics of propofol continuous infusion |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Propofol, Bacterial growth, Fungal growth, EDTA, Target controlled infusion