GAME-OvBLOC: Drug Wastage : Observational Study in the Operating Rooms of France

Sponsor

Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05609864

Collaborator

Sainte-Anne Military Teaching Hospital (Hôpital d'instruction des armées Sainte Anne) (Other)

1,500

Enrollment

Locations

2.9

Anticipated Duration (Months)

500

Patients Per Site

171

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 in the operating rooms by anesthesia department in France and to propose ways of improving health care practices.

Condition or Disease	Intervention/Treatment	Phase
Drug Use	Other: Quantification of intravenous drugs wastage

Detailed Description

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

Study Design

Study Type:

Observational

Anticipated Enrollment :

1500 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Drug Wastage : Observational Study in the Operating Rooms of France

Anticipated Study Start Date :

Feb 1, 2023

Anticipated Primary Completion Date :

May 1, 2023

Anticipated Study Completion Date :

May 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Intravenous (IV) drugs Patient's data and data relating to prepared/administrated/discarded IV drugs will be collected during 24 hours in the operating rooms by anesthesia department	Other: Quantification of intravenous drugs wastage 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.

Arm

Intervention/Treatment

Intravenous (IV) drugs

Patient's data and data relating to prepared/administrated/discarded IV drugs will be collected during 24 hours in the operating rooms by anesthesia department

Other: Quantification of intravenous drugs wastage

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.

Outcome Measures

Primary Outcome Measures

Ratio of overall wastage in milliliter (mL) of prepared and discarded IV drugs, to overall volume in milliliter (mL) of prepared IV drugs [24 hours]
Wastage is defined as : any prepared and unused drug that remains in syringe

Secondary Outcome Measures

Reason for discarding drug residues [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
Describe drug wastage for each kind of surgery/anesthesia [24 hours]
Drug wastage according to type of surgery and anaesthesia
Drug residues discarding process [24 hours]
Questionnaire on nursing practices on the choice of waste disposal circuits according to drugs
Cost of overall IV drugs wastage [24 hours]
Estimated cost of drug residues will be evaluated for each drug by the following formula : volume of discarded IV drugs x theoretical price
Describe drug wastage for each age group [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)
Describe waste and environmental impact of used plastic syringes [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.
Use of alternative to IV drugs [24 hours]
Alternatives : local anaesthesia and anaesthetic gases

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital of Bordeaux, Groupe Sud, Pôle médico-chirurgical Magellan	Pessac	Gironde	France	33600
2	Sainte-Anne Military Teaching Hospital	Toulon	Var	France	83000
3	Centre Hospitalier Intercommunal Toulon - La Seyne sur Mer	Toulon	Var	France	83100