AgingATROPAGENCT03390751
Atropine Weight and Risk of Postoperative Confusion in the Elderly
An observational study of Aging, run by University Hospital, Toulouse at 1 site in France.
Trial summary
The identification of a high atropine load of treatment received during hospitalization as a predictor of postoperative confusion could have various benefits: Pharmacoepidemiological: identify factors associated with postoperative confusion Clinics: by favoring treatments with a low atropine load during anesthesia… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Aging
- What is being tested?
- Data collection
- How many people
- 161 participants
- Where
- 1 siteFrance
- Study dates
- 14 Dec 2017to 31 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: The recruitment of patients will be ensured from the consultation of anesthesia or the entry into hospitalization by the anesthesia team of the orthopedic surgery department of the Hospital.
Who may be able to join
- Admitted to the orthopedic department for surgical management of a fracture of the upper end of the femur in emergency or for the installation of a hip or knee prosthesis
- Patient able to understand and respond to the protocol
- No opposition to the collection of data of the patient or his / her designee
Who cannot join
- Pre-existing confusion to surgery, detected by the CAM scale
- Serious or moderate head trauma less than three months old
- Removing / installing prosthesis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Atropine Weight and Risk of Postoperative Confusion After Hip Fracture Surgery or Prosthetic Surgery of the Lower Limb, in the Elderly
The identification of a high atropine load of treatment received during hospitalization as a predictor of postoperative confusion could have various benefits:
- Pharmacoepidemiological: identify factors associated with postoperative confusion
- Clinics: by favoring treatments with a low atropine load during anesthesia, the management of patients hospitalized in orthopedics. Similarly, stopping or re-evaluating treatments with a high atropine weight for scheduled surgery is an easy step to take.
- Socio-economic: by reducing the costs related to the occurrence of a confusional syndrome (over-treatment, prolonged hospital stay, loss of autonomy, institutionalization of patients...).
In total, the present study would improve the daily management of hospitalized patients and the practices of clinicians, by offering a decision-making aid.
- Conditions
- Aging
- Being tested
- Data collection
- Keywords
- atropinic drugs, confusion, elderly patients
- Medical subject headings
- Confusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collectionOther
The collection of data will be done by interrogation of the patient and his family / entourage and rereading of medical records
| Study group | Role | What they receive |
|---|---|---|
| Aged patients | Data collection of patients admitted to the orthopedic department of the University Hospital of Toulouse for surgical management of a fracture of the upper end of the femur in emergency or for the installation of a hip or knee prosthesis. Receives: Other: Data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Association between atropine load of medications on the risk of postoperative confusion
Occurrence of a postoperative confusion syndrome performed by Confusion Assessment Method (CAM) scale once a day. The CAM is a validated scale as a diagnostic scale for confusional syndrome at the patient's bedside with four parts : 1) confusion and fluctuation of symptoms, 2) inattention, 3) disorganization of thought, 4) disorder of consciousness.
Measured: up to 7 days
Atropinic load of drugs
The DURAN scale is the most recent and most comprehensive atropine load evaluation scale. This scale classifies the evaluated drugs into three categories: no anticholinergic power (atropine weight = 0), low anticholinergic activity (atropine weight = 1), high atropinic power (atropine weight = 3). All drugs received by the patient during 7 days will be classified with the Duran scale.
Measured: up to 7 days
Secondary outcomes (3)
Duration of hospitalization
Number of days of hospitalization (days) between surgery and discharge. Association between atropinic load of drugs and duration of hospitalization will be evaluated.
Measured: Up to discharge, an average of ten days
Autonomy
Description of autonomy of the patient at three months of surgery evaluated by the Activity Daily Living scale (ADL). The ADL scale evaluates activities of daily living: washing, dressing, going to the bathroom, ensuring transfers, continence and food. Each item is rated according to a level of dependence: independent (1 point), with assistance (0.5 points), unable to achieve (0 points). A total of 6 points indicates a total autonomy, and 0 a total dependency.
Measured: Month 3
Cognitive dysfunction
Appearance postoperative cognitive dysfunction by the Mini Mental State (MMS). the total score of MMS wil be collected.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2018
- Study start14 Dec 2017
- Primary completion31 Jan 2021
- Study completion31 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vincent Minville, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03390751
- Sponsor's protocol ID
- RC31/17/0202
- Other IDs
- 2017-A01847-46
- Acronym
- ATROPAGE
- Status last verified
- Apr 2026
- First submitted
- 16 Nov 2017
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Atropine Weight and Risk of Postoperative Confusion After Hip Fracture Surgery or Prosthetic Surgery of the Lower Limb, in the Elderly
- ClinicalTrials.gov ID
- NCT03390751
- Acronym / sponsor ID
- ATROPAGE / RC31/17/0202
- Conditions
- Aging
- Keywords
- atropinic drugs, confusion, elderly patients
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 14 Dec 2017 (actual)
- Primary completion
- 31 Jan 2021 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 4 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The identification of a high atropine load of treatment received during hospitalization as a predictor of postoperative confusion could have various benefits:
- Pharmacoepidemiological: identify factors associated with postoperative confusion
- Clinics: by favoring treatments with a low atropine load during anesthesia, the management of patients hospitalized in orthopedics. Similarly, stopping or re-evaluating treatments with a high atropine weight for scheduled surgery is an easy step to take.
- Socio-economic: by reducing the costs related to the occurrence of a confusional syndrome (over-treatment, prolonged hospital stay, loss of autonomy, institutionalization of patients...).
In total, the present study would improve the daily management of hospitalized patients and the practices of clinicians, by offering a decision-making aid.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aged patients | – | Other: Data collectionData collection of patients admitted to the orthopedic department of the University Hospital of Toulouse for surgical management of a fracture of the upper end of the femur in emergency or for the installation of a hip or knee prosthesis. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- The recruitment of patients will be ensured from the consultation of anesthesia or the entry into hospitalization by the anesthesia team of the orthopedic surgery department of the Hospital.
Key inclusion criteria (3 listed)
- Admitted to the orthopedic department for surgical management of a fracture of the upper end of the femur in emergency or for the installation of a hip or knee prosthesis
- Patient able to understand and respond to the protocol
- No opposition to the collection of data of the patient or his / her designee
Key exclusion criteria (3 listed)
- Pre-existing confusion to surgery, detected by the CAM scale
- Serious or moderate head trauma less than three months old
- Removing / installing prosthesis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Data collectionThe collection of data will be done by interrogation of the patient and his family / entourage and rereading of medical records | Other | Aged patients |
Primary outcome
Association between atropine load of medications on the risk of postoperative confusion
Time frame: up to 7 days
Occurrence of a postoperative confusion syndrome performed by Confusion Assessment Method (CAM) scale once a day. The CAM is a validated scale as a diagnostic scale for confusional syndrome at the patient's bedside with four parts : 1) confusion and fluctuation of symptoms, 2) inattention, 3) disorganization of thought, 4) disorder of consciousness.
Atropinic load of drugs
Time frame: up to 7 days
The DURAN scale is the most recent and most comprehensive atropine load evaluation scale. This scale classifies the evaluated drugs into three categories: no anticholinergic power (atropine weight = 0), low anticholinergic activity (atropine weight = 1), high atropinic power (atropine weight = 3). All drugs received by the patient during 7 days will be classified with the Duran scale.
3 secondary outcomes
Duration of hospitalization
Time frame: Up to discharge, an average of ten days
Autonomy
Time frame: Month 3
Cognitive dysfunction
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vincent Minville principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aging, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association between atropine load of medications on the risk of postoperative confusion (time frame: up to 7 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.