Atropine Weight and Risk of Postoperative Confusion in the Elderly

NCT03390751 | Completed

• 2 other identifiers: RC31/17/02022017-A01847-46
• Study Type: observational
• Target: 161
• Locations: 1 country
• Sites: 1

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.

Conditions

Aging

Keywords

atropinic drugs; confusion; elderly patients

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Duration of hospitalization

  Up to discharge, an average of ten days

• Autonomy

  Month 3

• Cognitive dysfunction

  baseline

Study Arms (1)

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

Data collection OTHER

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

Aged patients

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

Pierre-Paul-Riquet University Hospital

Toulouse, 31000, France

Location

MeSH Terms

Conditions

Confusion

Interventions

Data Collection

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Vincent Minville

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2017
• First Posted: January 4, 2018
• Study Start: December 14, 2017
• Primary Completion: January 31, 2021
• Study Completion: January 31, 2022
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)