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Clinical Trials/NCT04518839
NCT04518839
Unknown
Not Applicable

The Comparison of Cognitive Function, Symptoms of Depression and Anxiety, and Quality of Life in Patients After Hip Fracture Surgery Under General or Regional Anesthesia

University of Zagreb0 sites140 target enrollmentAugust 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Postoperative Cognitive Dysfunction
Sponsor
University of Zagreb
Enrollment
140
Primary Endpoint
change in cognition
Last Updated
5 years ago

Overview

Brief Summary

Postoperative cognitive dysfunction is a relatively common in elderly patients after hip surgery, but exact mechanism of its onset is still unclear as well as contributing factors. There is also increased incidence of depression and anxiety. Both affect the recovery after surgery, slow it down and reduce the quality of life. Patients will be divided into two groups, operated under regional anaesthesia and operated under general anaesthesia, and monitored after surgery. Patients will be tested before and after surgery to evaluate postoperative cognitive deficits, depression and anxiety scale and health-related quality of life questionnaire.

Registry
clinicaltrials.gov
Start Date
August 2020
End Date
September 2021
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Tea Fabijanić, MD

MD

University of Zagreb

Eligibility Criteria

Inclusion Criteria

  • Patients intended for surgical treatment of hip fractures ≥ 60 years
  • Patients who are category ASA I to ASA III will be included in research
  • Sufficient cognitive ability
  • Only those patients who have agreed to be participants in the research and have signed the consent for participation and informed consent.

Exclusion Criteria

  • Patients who refused to participate in the survey and who did not sign informed consent
  • Patients with ASA IV or more
  • Patients under 60 years
  • Severe psychiatric disorders involving the use of psychopharmaceuticals back three months
  • All patients who have other fractures in addition to hip fractures
  • Polytrauma
  • All patients scheduled for more than one surgical intervention during the procedure, or within the next 8 weeks
  • Patients who have been diagnosed with dementia, and / or are receiving anti-dementia drugs

Outcomes

Primary Outcomes

change in cognition

Time Frame: preoperatively/postoperative follow up 2 months

MoCA scale (Montreal Cognitive Assessment), F-A-S test

change in anxiety and depression

Time Frame: preoperatively/postoperative follow up 2 months

The HAD Scale (The Hospital Anxiety and Depression Scale)

change in quality of life

Time Frame: preoperatively/postoperative follow up 2 months

EQ-5D-5L Questionnaire

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