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

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

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.

Study Overview

• Status: Unknown
• Conditions: Quality of Life; Postoperative Cognitive Dysfunction; Hip Fractures; Depression, Anxiety

• Study Type: Observational
• Enrollment (Anticipated): 140

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing surgical treatment of hip fractures in Clinical Hospital Center Zagreb.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Group with regional anaesthesia
Group with general anaesthesia

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Zagreb
• Investigators: Principal Investigator: Tea Fabijanić, MD, University of Zagreb

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2020
• Primary Completion (Anticipated): August 1, 2021
• Study Completion (Anticipated): September 1, 2021

Study Registration Dates

• First Submitted: August 14, 2020
• First Submitted That Met QC Criteria: August 14, 2020
• First Posted (Actual): August 19, 2020

Study Record Updates

• Last Update Posted (Actual): August 19, 2020
• Last Update Submitted That Met QC Criteria: August 14, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: general anaesthesia; quality of life; depression; anxiety; hip fracture surgery; regional anaesthesia; postoperative cognitive dysfunction
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Pathologic Processes; Mood Disorders; Postoperative Complications; Wounds and Injuries; Neurocognitive Disorders; Leg Injuries; Cognition Disorders; Femoral Fractures; Hip Injuries; Depression; Depressive Disorder; Anxiety Disorders; Cognitive Dysfunction; Postoperative Cognitive Complications; Fractures, Bone; Hip Fractures
• Other Study ID Numbers: 643-03/20-07/33,380-130/134-20

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No