Postoperative Cognitive DysfunctionNCT04518839
The Comparison of Cognition, Depression and Anxiety, and Quality of Life After Hip Fracture Surgery Under General or Regional Anesthesia
An observational study of Postoperative Cognitive Dysfunction and Hip Fractures, run by University of Zagreb.
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Postoperative Cognitive Dysfunction, Hip Fractures, Depression, Anxiety
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- Aug 2020to Sep 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Adult, Older adult
Study population: Patients undergoing surgical treatment of hip fractures in Clinical Hospital Center Zagreb.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
- Keywords
- hip fracture surgery, regional anaesthesia, general anaesthesia, postoperative cognitive dysfunction, depression, anxiety, quality of life
- Medical subject headings
- Postoperative Cognitive Complications, Hip Fractures, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group with regional anaesthesia | Not described | |
| Group with general anaesthesia | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in cognition
MoCA scale (Montreal Cognitive Assessment), F-A-S test
Measured: preoperatively/postoperative follow up 2 months
change in anxiety and depression
The HAD Scale (The Hospital Anxiety and Depression Scale)
Measured: preoperatively/postoperative follow up 2 months
change in quality of life
EQ-5D-5L Questionnaire
Measured: preoperatively/postoperative follow up 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2020
- Study startAug 2020 (estimated)
- Primary completionAug 2021 (estimated)
- Study completionSep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Cognitive DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zagreb
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tea Fabijanić, MD, University of Zagreb
- Investigators
- Tea Fabijanić, MD, Principal investigator, University of Zagreb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04518839
- Sponsor's protocol ID
- 643-03/20-07/33,380-130/134-20
- Status last verified
- Aug 2020
- First submitted
- 14 Aug 2020
- Last updated
- 19 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04518839
- Acronym / sponsor ID
- 643-03/20-07/33,380-130/134-20
- Keywords
- hip fracture surgery, regional anaesthesia, general anaesthesia, postoperative cognitive dysfunction, depression, anxiety, quality of life
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- University of ZagrebUniversity, hospital or other
- Study start
- Aug 2020 (estimated)
- Primary completion
- Aug 2021 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 19 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group with regional anaesthesia | – | – |
| Group with general anaesthesia | – | – |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing surgical treatment of hip fractures in Clinical Hospital Center Zagreb.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2020.
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The Effect of Single Lung Ventilation Duration and Intraoperative Brain Oxygenation on Cognitive Function and Postoperative Pain in Geriatric Patients
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tea Fabijanić, MD principal investigator
University of Zagreb
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Cognitive Dysfunction and Hip Fractures, run by University of Zagreb.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tea Fabijanić, MD (00385915698801, tea.fabijan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in cognition (time frame: preoperatively/postoperative follow up 2 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2020.