The Comparison of Cognition, Depression and Anxiety, and Quality of Life After Hip Fracture Surgery Under General or Regional Anesthesia

NCT ID: NCT04518839

Last Updated: 2020-08-19

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 140 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-08-31
• Study Completion Date: 2021-09-30

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.

Conditions

Postoperative Cognitive Dysfunction; Hip Fractures; Depression, Anxiety; Quality of Life

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Group with regional anaesthesia

No interventions assigned to this group

Group with general anaesthesia

No interventions assigned to this group

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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Zagreb

OTHER

Sponsor Role: lead

Responsible Party

Tea Fabijanić, MD

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tea Fabijanić, MD

Role: PRINCIPAL_INVESTIGATOR

University of Zagreb

Central Contacts

Tea Fabijanić, MD

Role: CONTACT

tea.fabijan@gmail.com

00385915698801

Other Identifiers

643-03/20-07/33,380-130/134-20

Identifier Type: -

Identifier Source: org_study_id