- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05609864
Drug Wastage : Observational Study in the Operating Rooms of France (GAME-OvBLOC)
Environmental awareness is leading medical field to question its responsibility and possibilities for action.
Drug residues can have a major environmental impact as per their bioaccumulation, toxicity and persistence characteristics, depending on where they are discarded. In France, drug residues should be disposed of by incineration, but in practice this is not systematic. Moreover, data on drug wastage in the operating rooms by anesthesia department are rare.
The GAME-OvBLOC observational study aim to evaluate drug wastage in the operating rooms by anesthesia department in France and to propose ways of improving health care practices.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Paris, France, 75015
- Hôpital Européen Georges Pompidou
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Paris, France, 75010
- Hôpital Saint Louis (AP-HP)
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Paris, France, 75013
- Hôpital La Pitié-Salpétrière
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Paris, France, 75674
- Institut Mutualiste Montsouris
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Paris, France, 75020
- Groupe Hospitalier Diaconesses Croix Saint Simon
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Paris, France, 75010
- Hôpital Lariboisière (AP-HP)
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Paris, France, 75012
- Hôpital Trousseau (AP-HP)
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Paris, France, 75020
- Hôpital Tenon (AP-HP)
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Villejuif, France, 94800
- Hôpital Paul Brousse (AP-HP)
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Alpes-Maritimes
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Cannes, Alpes-Maritimes, France, 06400
- Centre Hospitalier de Cannes
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Ardennes
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Charleville-Mézières, Ardennes, France, 08000
- Centre Hospitalier de Charleville-Mezieres
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Aveyron
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Rodez, Aveyron, France, 12000
- Centre Hospitalier Jacques Puel
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Bas-Rhin
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Strasbourg, Bas-Rhin, France, 67000
- CHU de Strasbourg - IHU
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Bouches-du-Rhône
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Marseille, Bouches-du-Rhône, France, 13005
- Hôpital La Timone (AP-HM)
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Marseille, Bouches-du-Rhône, France, 13015
- Hôpital Nord (AP-HM)
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Calvados
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Caen, Calvados, France, 14000
- CHU de Caen
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Cantal
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Aurillac, Cantal, France, 15000
- Centre Hospitalier Henri Mondor
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Charente-Maritime
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La Rochelle, Charente-Maritime, France, 17019
- Groupe Hospitalier Littoral Atlantique
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Corrèze
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Brive-la-Gaillarde, Corrèze, France, 19100
- Centre Hospitalier de Brive-la-Gaillarde
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Côte d'Or
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Dijon, Côte d'Or, France, 21000
- Chu de Dijon
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Doubs
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Besançon, Doubs, France, 25000
- Chu Jean Minjoz
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Drôme
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Valence, Drôme, France, 26000
- Centre Hospitalier de Valence
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Essonne
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Corbeil-Essonnes, Essonne, France, 91106
- Centre Hospitalier Sud Francilien
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Finistère
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Brest, Finistère, France, 29240
- HIA Clermont Tonnerre
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Brest, Finistère, France, 29609
- CHRU de Brest
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Quimper, Finistère, France, 29000
- Centre Hospitalier de Cornouailles
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Gard
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Nîmes, Gard, France, 30900
- CHU de Nîmes
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Gironde
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Bordeaux, Gironde, France, 33000
- CHU de Bordeaux - Groupe hospitalier Pellegrin
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La Teste-de-Buch, Gironde, France, 33260
- Centre Hospitalier d'Arcachon
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Pessac, Gironde, France, 33600
- CHU de Bordeaux, Groupe Sud
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Pessac, Gironde, France, 33600
- Clinique mutualiste de Pessac
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Haute Vienne
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Limoges, Haute Vienne, France, 87042
- CHU de Limoges
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Haute-Garonne
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Cornebarrieu, Haute-Garonne, France, 31700
- Clinique des Cèdres
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Quint-Fonsegrives, Haute-Garonne, France, 31130
- Clinique La Croix Du Sud
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Saint-Jean, Haute-Garonne, France, 31240
- Clinique de l'Union
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Toulouse, Haute-Garonne, France, 31400
- CHU de Toulouse - Hôpital Rangueil
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Haute-Loire
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Le Puy-en-Velay, Haute-Loire, France, 43012
- Centre Hospitalier Emile Roux
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Hauts-de-Seine
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Clamart, Hauts-de-Seine, France, 92141
- HIA Percy Clamart
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Le Plessis-Robinson, Hauts-de-Seine, France, 92350
- Hôpital Marie Lannelongue
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Ille-et-Vilaine
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Rennes, Ille-et-Vilaine, France, 35033
- CHU de Rennes - Pontchaillou
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Rennes, Ille-et-Vilaine, France, 35200
- CHU de Rennes - Hôpital Sud
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Rennes, Ille-et-Vilaine, France, 44345
- Clinique mutualiste La Sagesse
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Isère
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Grenoble, Isère, France, 38100
- CHU de Grenoble
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La Réunion
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Saint-Denis, La Réunion, France, 97400
- CHU de la réunion
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Landes
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Dax, Landes, France, 40100
- Centre Hospitalier de Dax
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Loiret
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Amilly, Loiret, France, 45200
- Centre Hospitalier de l'Agglomération Montargoise
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Olivet, Loiret, France, 45160
- Clinique de l'Archette
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Maine-et-Loire
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Angers, Maine-et-Loire, France, 49100
- CHU d'Angers
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Marne
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Reims, Marne, France, 51100
- Institut Godinot
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Meurthe-et-Moselle
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Vandœuvre-lès-Nancy, Meurthe-et-Moselle, France, 54519
- Institut de Cancerologie de Lorraine
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Morbihan
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Lorient, Morbihan, France, 56322
- Groupe Hospitalier Bretagne Sud
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Nord
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Lille, Nord, France, 59000
- Centre Oscar Lambret
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Lille, Nord, France, 59037
- CHU de Lille - Hôpital Huriez
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Lille, Nord, France, 59037
- CHU de Lille - Hôpital Roger Salengro
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Lille, Nord, France, 59000
- CHU de Lille - Institut coeur poumon
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Lille, Nord, France, 59037
- CHU de Lille - Hôpital Jeanne de Flandre
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Pas-de-Calais
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Arras, Pas-de-Calais, France, 62000
- Hopital Privé Arras les Bonnettes
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Lens, Pas-de-Calais, France, 62300
- Centre Hospitalier de LENS
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Puy-de-Dôme
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Clermont-Ferrand, Puy-de-Dôme, France, 63000
- CHU de Clermont-Ferrand
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Clermont-Ferrand, Puy-de-Dôme, France, 63000
- Clinique de la Plaine Santé
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Pyrénées-Atlantiques
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Biarritz, Pyrénées-Atlantiques, France, 64200
- Clinique Aguiléra
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Pau, Pyrénées-Atlantiques, France, 64046
- Centre Hospitalier De Pau
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Rhône
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Bron, Rhône, France, 69500
- Hôpital mère-enfant (HCL)
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Lyon, Rhône, France, 69008
- Centre Leon Berard
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Lyon, Rhône, France, 69003
- Hopital Edouard Herriot
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Lyon, Rhône, France, 69009
- Clinique de la Sauvegarde
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Seine-Maritime
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Rouen, Seine-Maritime, France, 76000
- CHU de Rouen
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Somme
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Amiens, Somme, France, 80054
- CHU d'AMIENS
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Amiens, Somme, France, 80090
- Clinique Victor Pauchet
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Tarn
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Castres, Tarn, France
- Centre Hospitalier Intercommunal Castres-Mazamet
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Territoire De Belfort
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Trévenans, Territoire De Belfort, France, 90400
- Hôpital Nord Franche-Comté
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Val d'Oise
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Beaumont, Val d'Oise, France, 63110
- Hôpital Privé de la Chataigneraie
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Beaumont-sur-Oise, Val d'Oise, France, 95260
- Hôpital NOVO - Site de Beaumont-sur-Oise
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Cergy-Pontoise, Val d'Oise, France, 90079
- Hôpital NOVO - Site de Pontoise
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Val-de-Marne
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Villejuif, Val-de-Marne, France, 94805
- Institut Gustave Roussy
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Villeneuve-Saint-Georges, Val-de-Marne, France, 94190
- Centre Hospitalier Intercommunal de Villeneuve Saint Georges
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Var
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Toulon, Var, France, 83000
- Sainte-Anne Military Teaching Hospital
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Toulon, Var, France, 83100
- Centre Hospitalier Intercommunal Toulon - La Seyne sur Mer
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Vaucluse
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Vantoux, Vaucluse, France, 57070
- Hôpital Robert Schuman-Groupe UNEOS
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Vendée
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La Roche-sur-Yon, Vendée, France, 85000
- Centre Hospitalier Départemental de Vendée
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Pointe-à-Pitre, Guadeloupe, 97159
- CHU de Guadeloupe
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Mamoudzou, Mayotte, 97600
- Centre hospitalier de Mayotte
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Monaco, Monaco, 98000
- Centre Hospitalier Princesse Grace
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- All patients who will need an anesthesia act in operating room during a 24 hours period
Exclusion Criteria:
- Patient opposition to participate in the study or parents opposition if the patient is a child or patient family opposition if the patient is not capable of being informed
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Injectable drugs
Patient's data and data relating to prepared/administrated/discarded injectable drugs will be collected during 24 hours in the operating rooms by anesthesia department
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Drugs are prescribed at discretion of physicians.
For each patient who have anesthesia in the operating room, all labelled syringes having contained drugs (name + dilution) are collected and analyzed.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Ratio of overall wastage in milliliter (mL) of prepared and discarded injectable drugs, to overall volume in milliliter (mL) of prepared injectable drugs
Time Frame: 24 hours
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Wastage is defined as : any prepared and unused drug that remains in syringe
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24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Reason for discarding drug residues
Time Frame: 24 hours
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The reason of waste full syringe will be noticed : 1/ prepared in advance and not used ; 2/ prescription change ; 3/ preparation error ; 4/ other reason
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24 hours
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Describe drug wastage for each kind of surgery/anesthesia
Time Frame: 24 hours
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Drug wastage according to type of surgery and anaesthesia
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24 hours
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Drug residues discarding process
Time Frame: 24 hours
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Questionnaire on nursing practices on the choice of waste disposal circuits according to drugs
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24 hours
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Describe drug wastage for each age group
Time Frame: 24 hours
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Drug wastage according to the following age groups : adult (≥18 years old) and pediatrics (< 1 year old, 1-5 years old, ≥ 6 years old)
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24 hours
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Describe waste and environmental impact of used plastic syringes
Time Frame: 24 hours
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Number and volume of used syringes, use of pre-filled syringes, refilling of syringes and multi-patient use. Environmental impact is indirectly assessed by type of plastic used and the transport distance from the production site to France. |
24 hours
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Cost of overall injectable drugs wastage
Time Frame: 24 hours
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Estimated cost of drug residues will be evaluated for each drug by the following formula : volume of discarded injectable drugs x theoretical price |
24 hours
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Use of alternative to injectable drugs
Time Frame: 24 hours
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Alternatives : local anaesthesia and anaesthetic gases
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24 hours
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Collaborators and Investigators
Collaborators
Investigators
- Study Director: Erwan D'Aranda, MD, Sainte-Anne Military Teaching Hospital (Hôpital d'instruction des armées Sainte Anne)
Publications and helpful links
General Publications
- McGain F, Muret J, Lawson C, Sherman JD. Environmental sustainability in anaesthesia and critical care. Br J Anaesth. 2020 Nov;125(5):680-692. doi: 10.1016/j.bja.2020.06.055. Epub 2020 Aug 12.
- Barbariol F, Deana C, Lucchese F, Cataldi G, Bassi F, Bove T, Vetrugno L, De Monte A. Evaluation of Drug Wastage in the Operating Rooms and Intensive Care Units of a Regional Health Service. Anesth Analg. 2021 May 1;132(5):1450-1456. doi: 10.1213/ANE.0000000000005457.
- Mankes RF. Propofol wastage in anesthesia. Anesth Analg. 2012 May;114(5):1091-2. doi: 10.1213/ANE.0b013e31824ea491. Epub 2012 Mar 13.
- Ramstrom H, Martini S, Borgendahl J, Agerstrand M, Larfars G, Ovesjo ML. Pharmaceuticals and Environment: a web-based decision support for considering environmental aspects of medicines in use. Eur J Clin Pharmacol. 2020 Aug;76(8):1151-1160. doi: 10.1007/s00228-020-02885-1. Epub 2020 May 9.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2023-CHITS-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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