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

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04518839
• Other study ID #: 643-03/20-07/33,380-130/134-20
• Status: Not yet recruiting
• Start date: August 2020
• Est. completion date: September 2021

Study information

• Verified date: August 2020
• Source: University of Zagreb
• Contact: Tea Fabijanic, MD
• Phone: 00385915698801
• Email: tea.fabijan[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 140
• Est. completion date: September 2021
• Est. primary completion date: August 2021
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Cognitive Dysfunction
• Depression
• Depression, Anxiety
• Depressive Disorder
• Fractures, Bone
• Hip Fractures
• Postoperative Cognitive Dysfunction
• Quality of Life

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Zagreb

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in cognition	MoCA scale (Montreal Cognitive Assessment), F-A-S test	preoperatively/postoperative follow up 2 months
Primary	change in anxiety and depression	The HAD Scale (The Hospital Anxiety and Depression Scale)	preoperatively/postoperative follow up 2 months
Primary	change in quality of life	EQ-5D-5L Questionnaire	preoperatively/postoperative follow up 2 months