Atropine Weight and Risk of Postoperative Confusion in the Elderly

Aging Clinical Trial

— ATROPAGE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03390751
• Other study ID #: RC31/17/0202
• Secondary ID: 2017-A01847-46
• Status: Recruiting
• Start date: December 14, 2017
• Est. completion date: January 2022

Study information

• Verified date: July 2020
• Source: University Hospital, Toulouse
• Contact: Vincent Minville, MD PhD
• Phone: 33-5 61 32 27 91
• Email: minville.v[@]chu-toulouse.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: January 2022
• Est. primary completion date: January 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aging
• Confusion

Intervention

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

Locations

Country	Name	City	State
France	Pierre-Paul-Riquet University Hospital	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	Cognitive dysfunction	Appearance postoperative cognitive dysfunction by the Mini Mental State (MMS). the total score of MMS wil be collected.	baseline