Skip to content

Atropine Weight and Risk of Postoperative Confusion in the Elderly

Atropine Weight and Risk of Postoperative Confusion After Hip Fracture Surgery or Prosthetic Surgery of the Lower Limb, in the Elderly

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03390751
Acronym
ATROPAGE
Enrollment
161
Registered
2018-01-04
Start date
2017-12-14
Completion date
2022-01-31
Last updated
2026-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aging

Keywords

atropinic drugs, confusion, elderly patients

Brief 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, 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.

Interventions

OTHERData collection

The collection of data will be done by interrogation of the patient and his family / entourage and rereading of medical records

Sponsors

University Hospital, Toulouse
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* Pre-existing confusion to surgery, detected by the CAM scale * Serious or moderate head trauma less than three months old * Removing / installing prosthesis.

Design outcomes

Primary

MeasureTime frameDescription
Association between atropine load of medications on the risk of postoperative confusionup to 7 daysOccurrence 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 drugsup to 7 daysThe 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.

Secondary

MeasureTime frameDescription
Duration of hospitalizationUp to discharge, an average of ten daysNumber of days of hospitalization (days) between surgery and discharge. Association between atropinic load of drugs and duration of hospitalization will be evaluated.
AutonomyMonth 3Description 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.
Cognitive dysfunctionbaselineAppearance postoperative cognitive dysfunction by the Mini Mental State (MMS). the total score of MMS wil be collected.

Countries

France

Contacts

PRINCIPAL_INVESTIGATORVincent Minville

University Hospital, Toulouse

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 30, 2026