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

Completed

Conditions

Detailed Description

Observational study with data collection over a 24-hour business day. Data collected refer to healthcare team's practices and patients.

Study Type

Observational

Enrollment (Actual)

3763

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Paris, France, 75015
        • Hôpital Européen Georges Pompidou
      • Paris, France, 75010
        • Hôpital Saint Louis (AP-HP)
      • Paris, France, 75013
        • Hôpital La Pitié-Salpétrière
      • Paris, France, 75674
        • Institut Mutualiste Montsouris
      • Paris, France, 75020
        • Groupe Hospitalier Diaconesses Croix Saint Simon
      • Paris, France, 75010
        • Hôpital Lariboisière (AP-HP)
      • Paris, France, 75012
        • Hôpital Trousseau (AP-HP)
      • Paris, France, 75020
        • Hôpital Tenon (AP-HP)
      • Villejuif, France, 94800
        • Hôpital Paul Brousse (AP-HP)
    • Alpes-Maritimes
      • Cannes, Alpes-Maritimes, France, 06400
        • Centre Hospitalier de Cannes
    • Ardennes
      • Charleville-Mézières, Ardennes, France, 08000
        • Centre Hospitalier de Charleville-Mezieres
    • Aveyron
      • Rodez, Aveyron, France, 12000
        • Centre Hospitalier Jacques Puel
    • Bas-Rhin
      • Strasbourg, Bas-Rhin, France, 67000
        • CHU de Strasbourg - IHU
    • Bouches-du-Rhône
      • Marseille, Bouches-du-Rhône, France, 13005
        • Hôpital La Timone (AP-HM)
      • Marseille, Bouches-du-Rhône, France, 13015
        • Hôpital Nord (AP-HM)
    • Calvados
      • Caen, Calvados, France, 14000
        • CHU de Caen
    • Cantal
      • Aurillac, Cantal, France, 15000
        • Centre Hospitalier Henri Mondor
    • Charente-Maritime
      • La Rochelle, Charente-Maritime, France, 17019
        • Groupe Hospitalier Littoral Atlantique
    • Corrèze
      • Brive-la-Gaillarde, Corrèze, France, 19100
        • Centre Hospitalier de Brive-la-Gaillarde
    • Côte d'Or
      • Dijon, Côte d'Or, France, 21000
        • Chu de Dijon
    • Doubs
      • Besançon, Doubs, France, 25000
        • Chu Jean Minjoz
    • Drôme
      • Valence, Drôme, France, 26000
        • Centre Hospitalier de Valence
    • Essonne
      • Corbeil-Essonnes, Essonne, France, 91106
        • Centre Hospitalier Sud Francilien
    • Finistère
      • Brest, Finistère, France, 29240
        • HIA Clermont Tonnerre
      • Brest, Finistère, France, 29609
        • CHRU de Brest
      • Quimper, Finistère, France, 29000
        • Centre Hospitalier de Cornouailles
    • Gard
      • Nîmes, Gard, France, 30900
        • CHU de Nîmes
    • Gironde
      • Bordeaux, Gironde, France, 33000
        • CHU de Bordeaux - Groupe hospitalier Pellegrin
      • La Teste-de-Buch, Gironde, France, 33260
        • Centre Hospitalier d'Arcachon
      • Pessac, Gironde, France, 33600
        • CHU de Bordeaux, Groupe Sud
      • Pessac, Gironde, France, 33600
        • Clinique mutualiste de Pessac
    • Haute Vienne
      • Limoges, Haute Vienne, France, 87042
        • CHU de Limoges
    • Haute-Garonne
      • Cornebarrieu, Haute-Garonne, France, 31700
        • Clinique des Cèdres
      • Quint-Fonsegrives, Haute-Garonne, France, 31130
        • Clinique La Croix Du Sud
      • Saint-Jean, Haute-Garonne, France, 31240
        • Clinique de l'Union
      • Toulouse, Haute-Garonne, France, 31400
        • CHU de Toulouse - Hôpital Rangueil
    • Haute-Loire
      • Le Puy-en-Velay, Haute-Loire, France, 43012
        • Centre Hospitalier Emile Roux
    • Hauts-de-Seine
      • Clamart, Hauts-de-Seine, France, 92141
        • HIA Percy Clamart
      • Le Plessis-Robinson, Hauts-de-Seine, France, 92350
        • Hôpital Marie Lannelongue
    • Ille-et-Vilaine
      • Rennes, Ille-et-Vilaine, France, 35033
        • CHU de Rennes - Pontchaillou
      • Rennes, Ille-et-Vilaine, France, 35200
        • CHU de Rennes - Hôpital Sud
      • Rennes, Ille-et-Vilaine, France, 44345
        • Clinique mutualiste La Sagesse
    • Isère
      • Grenoble, Isère, France, 38100
        • CHU de Grenoble
    • La Réunion
      • Saint-Denis, La Réunion, France, 97400
        • CHU de la réunion
    • Landes
      • Dax, Landes, France, 40100
        • Centre Hospitalier de Dax
    • Loiret
      • Amilly, Loiret, France, 45200
        • Centre Hospitalier de l'Agglomération Montargoise
      • Olivet, Loiret, France, 45160
        • Clinique de l'Archette
    • Maine-et-Loire
      • Angers, Maine-et-Loire, France, 49100
        • CHU d'Angers
    • Marne
      • Reims, Marne, France, 51100
        • Institut Godinot
    • Meurthe-et-Moselle
      • Vandœuvre-lès-Nancy, Meurthe-et-Moselle, France, 54519
        • Institut de Cancerologie de Lorraine
    • Morbihan
      • Lorient, Morbihan, France, 56322
        • Groupe Hospitalier Bretagne Sud
    • Nord
      • Lille, Nord, France, 59000
        • Centre Oscar Lambret
      • Lille, Nord, France, 59037
        • CHU de Lille - Hôpital Huriez
      • Lille, Nord, France, 59037
        • CHU de Lille - Hôpital Roger Salengro
      • Lille, Nord, France, 59000
        • CHU de Lille - Institut coeur poumon
      • Lille, Nord, France, 59037
        • CHU de Lille - Hôpital Jeanne de Flandre
    • Pas-de-Calais
      • Arras, Pas-de-Calais, France, 62000
        • Hopital Privé Arras les Bonnettes
      • Lens, Pas-de-Calais, France, 62300
        • Centre Hospitalier de LENS
    • Puy-de-Dôme
      • Clermont-Ferrand, Puy-de-Dôme, France, 63000
        • CHU de Clermont-Ferrand
      • Clermont-Ferrand, Puy-de-Dôme, France, 63000
        • Clinique de la Plaine Santé
    • Pyrénées-Atlantiques
      • Biarritz, Pyrénées-Atlantiques, France, 64200
        • Clinique Aguiléra
      • Pau, Pyrénées-Atlantiques, France, 64046
        • Centre Hospitalier De Pau
    • Rhône
      • Bron, Rhône, France, 69500
        • Hôpital mère-enfant (HCL)
      • Lyon, Rhône, France, 69008
        • Centre Leon Berard
      • Lyon, Rhône, France, 69003
        • Hopital Edouard Herriot
      • Lyon, Rhône, France, 69009
        • Clinique de la Sauvegarde
    • Seine-Maritime
      • Rouen, Seine-Maritime, France, 76000
        • CHU de Rouen
    • Somme
      • Amiens, Somme, France, 80054
        • CHU d'AMIENS
      • Amiens, Somme, France, 80090
        • Clinique Victor Pauchet
    • Tarn
      • Castres, Tarn, France
        • Centre Hospitalier Intercommunal Castres-Mazamet
    • Territoire De Belfort
      • Trévenans, Territoire De Belfort, France, 90400
        • Hôpital Nord Franche-Comté
    • Val d'Oise
      • Beaumont, Val d'Oise, France, 63110
        • Hôpital Privé de la Chataigneraie
      • Beaumont-sur-Oise, Val d'Oise, France, 95260
        • Hôpital NOVO - Site de Beaumont-sur-Oise
      • Cergy-Pontoise, Val d'Oise, France, 90079
        • Hôpital NOVO - Site de Pontoise
    • Val-de-Marne
      • Villejuif, Val-de-Marne, France, 94805
        • Institut Gustave Roussy
      • Villeneuve-Saint-Georges, Val-de-Marne, France, 94190
        • Centre Hospitalier Intercommunal de Villeneuve Saint Georges
    • Var
      • Toulon, Var, France, 83000
        • Sainte-Anne Military Teaching Hospital
      • Toulon, Var, France, 83100
        • Centre Hospitalier Intercommunal Toulon - La Seyne sur Mer
    • Vaucluse
      • Vantoux, Vaucluse, France, 57070
        • Hôpital Robert Schuman-Groupe UNEOS
    • Vendée
      • La Roche-sur-Yon, Vendée, France, 85000
        • Centre Hospitalier Départemental de Vendée
      • Pointe-à-Pitre, Guadeloupe, 97159
        • CHU de Guadeloupe
      • Mamoudzou, Mayotte, 97600
        • Centre hospitalier de Mayotte
      • Monaco, Monaco, 98000
        • Centre Hospitalier Princesse Grace

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All patients who will need an anesthesia act in operating room during a 24 hours period

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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.

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
Wastage is defined as : any prepared and unused drug that remains in syringe
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reason for discarding drug residues
Time Frame: 24 hours
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
24 hours
Describe drug wastage for each kind of surgery/anesthesia
Time Frame: 24 hours
Drug wastage according to type of surgery and anaesthesia
24 hours
Drug residues discarding process
Time Frame: 24 hours
Questionnaire on nursing practices on the choice of waste disposal circuits according to drugs
24 hours
Describe drug wastage for each age group
Time Frame: 24 hours
Drug wastage according to the following age groups : adult (≥18 years old) and pediatrics (< 1 year old, 1-5 years old, ≥ 6 years old)
24 hours
Describe waste and environmental impact of used plastic syringes
Time Frame: 24 hours

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
Cost of overall injectable drugs wastage
Time Frame: 24 hours

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
Use of alternative to injectable drugs
Time Frame: 24 hours
Alternatives : local anaesthesia and anaesthetic gases
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Erwan D'Aranda, MD, Sainte-Anne Military Teaching Hospital (Hôpital d'instruction des armées Sainte Anne)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 6, 2023

Primary Completion (Actual)

July 20, 2023

Study Completion (Actual)

July 20, 2023

Study Registration Dates

First Submitted

November 2, 2022

First Submitted That Met QC Criteria

November 2, 2022

First Posted (Actual)

November 8, 2022

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 10, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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