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

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.

Study Overview

• Status: Unknown
• Conditions: Aging
• Intervention / Treatment: Other: Data collection

• Study Type: Observational
• Enrollment (Anticipated): 130

Contacts and Locations

• Study Contact: Name: Vincent Minville, MD PhD; Phone Number: 33-5 61 32 27 91; Email: minville.v@chu-toulouse.fr
• Study Contact Backup: Name: Marie PIEL-JULIAN

Study Locations

• France
  • Toulouse, France, 31000
    • Recruiting
    • Pierre-Paul-Riquet University Hospital
    • Contact: Vincent Minville, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	up to 7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Month 3
Cognitive dysfunction	Appearance postoperative cognitive dysfunction by the Mini Mental State (MMS). the total score of MMS wil be collected.	baseline

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Investigators: Principal Investigator: Vincent Minville, University Hospital, Toulouse

Study record dates

Study Major Dates

• Study Start (Actual): December 14, 2017
• Primary Completion (Anticipated): January 1, 2021
• Study Completion (Anticipated): January 1, 2022

Study Registration Dates

• First Submitted: November 16, 2017
• First Submitted That Met QC Criteria: January 3, 2018
• First Posted (Actual): January 4, 2018

Study Record Updates

• Last Update Posted (Actual): July 30, 2020
• Last Update Submitted That Met QC Criteria: July 29, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: confusion; elderly patients; atropinic drugs
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Confusion
• Other Study ID Numbers: RC31/17/0202; 2017-A01847-46 (Registry Identifier: ANSM Register)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No