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NCT Number: NCT03390751

Atropine Weight and Risk of Postoperative Confusion 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.

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Key information

Conditions

Aging Confusion Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pierre-Paul-Riquet University Hospital

Toulouse, 31000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Data Collection

Other

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

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Duration of hospitalization

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

    Number of days of hospitalization (days) between surgery and discharge. Association between atropinic load of drugs and duration of hospitalization will be evaluated.

  2. Autonomy

    Time frame: Month 3

    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.

  3. Cognitive dysfunction

    Time frame: baseline

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

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study title

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

Acronym: ATROPAGE

Important dates

Study start
2017
Primary completion
2021
Study completion
2022
First posted
Jan 4, 2018
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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