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临床试验/NCT03390751
NCT03390751Unknown不适用

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

University Hospital, Toulouse1 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2017年12月14日最近更新:
适应症

试验速览

阶段
不适用
入组人数
130
试验地点
1
主要终点
Association between atropine load of medications on the risk of postoperative confusion

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

结局指标

主要结局

Association between atropine load of medications on the risk of postoperative confusion

时间窗: 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.

Atropinic load of drugs

时间窗: 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.

次要结局

  • Duration of hospitalization(Up to discharge, an average of ten days)
  • Autonomy(Month 3)
  • Cognitive dysfunction(baseline)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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