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Atropine Weight and Risk of Postoperative Confusion in the Elderly (ATROPAGE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03390751
Recruitment Status : Recruiting
First Posted : January 4, 2018
Last Update Posted : July 30, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

Study Description
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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.


Condition or disease Intervention/treatment
Aging Other: Data collection

Study Design
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Study Type : Observational
Estimated Enrollment : 130 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Atropine Weight and Risk of Postoperative Confusion After Hip Fracture Surgery or Prosthetic Surgery of the Lower Limb, in the Elderly
Actual Study Start Date : December 14, 2017
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
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
The collection of data will be done by interrogation of the patient and his family / entourage and rereading of medical records


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   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.
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03390751


Contacts
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Contact: Vincent Minville, MD PhD 33-5 61 32 27 91 minville.v@chu-toulouse.fr
Contact: Marie PIEL-JULIAN

Locations
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France
Pierre-Paul-Riquet University Hospital Recruiting
Toulouse, France, 31000
Contact: Vincent Minville, MD         
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
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Principal Investigator: Vincent Minville University Hospital, Toulouse
More Information
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Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT03390751    
Other Study ID Numbers: RC31/17/0202
2017-A01847-46 ( Registry Identifier: ANSM Register )
First Posted: January 4, 2018    Key Record Dates
Last Update Posted: July 30, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Toulouse:
atropinic drugs
confusion
elderly patients
Additional relevant MeSH terms:
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Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases