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CompletedNCT03390751ATROPAGEUpdated Apr 29, 2026

Atropine Weight and Risk of Postoperative Confusion in the Elderly

An observational study in Aging, sponsored by University Hospital, Toulouse. Completed at 1 site in France. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-04-29.

Sponsored by University Hospital, Toulouse · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
161
Ages
65 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Aging

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Keywords

  • atropinic drugs
  • confusion
  • elderly patients
03

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

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

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.
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
161 participants (actual)
Patient registry
No

Groups and cohorts

  • 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.

    Other: Data collection

Interventions

  • OtherData collection

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

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: up to 7 days

  2. 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.

    Time frame: up to 7 days

Secondary outcomes

  1. 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.

    Time frame: Up to discharge, an average of ten days

  2. 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.

    Time frame: Month 3

  3. Cognitive dysfunction

    Appearance postoperative cognitive dysfunction by the Mini Mental State (MMS). the total score of MMS wil be collected.

    Time frame: baseline

06

Study locations

1 site
  • Pierre-Paul-Riquet University Hospital
    Toulouse, 31000, France
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Registry details

Key details

Study ID
NCT03390751
Lead sponsor
University Hospital, Toulouse
Responsible party
Sponsor
First posted
Jan 4, 2018
Start date
Dec 14, 2017
Primary completion
Jan 31, 2021
Completion
Jan 31, 2022
Last update
Apr 29, 2026

Study contacts

Vincent Minville
principal investigator · University Hospital, Toulouse

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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