Postoperative Cognitive DysfunctionElderlyPOCDNCT02068742
Postoperative Cognitive Dysfunction in Elderly
A study testing battery neuropsychological tests in people with Postoperative Cognitive Dysfunction, run by Università degli Studi dell'Insubria at 1 site in Italy.
Trial summary
Interventional Study of Early Postoperative Cognitive Dysfunction in Elderly Patients Undergoing General Anesthesia The main purpose of this study is to determine the incidence of early postoperative cognitive dysfunction in elderly patients and its time course. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Postoperative Cognitive Dysfunction
- What is being tested?
- battery neuropsychological tests
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2014to Jan 2018
- Phase
- Interventional
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age > 65 years
- Surgery scheduled under general anesthesia, that is expected to last 90 minutes or longer for the arm experimental
Who cannot join
- A score of 20 or less on the Mini-Mental State Examination (MMSE)
- Illiteracy
- Can't understand Italian language
- Serious hearing or vision impairment not treatable
- A history of any disease of the central nervous system
- A current or past history of psychiatric illness
Show all 10Show fewer
- A current use of major tranquilizers or antidepressants
- alcoholism or drug dependence or abuse
- Scheduled to undergo cardiac, carotid or intracranial procedures
- Not expected to be alive or available to complete testing at 90 days after surgery
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Ospedale di Circolo e Fondazione Macchi
Varese, 21100
Paolo Severgnini, Professor, 00390332278801, paolo.severgnini@uninsubria.it
Paolo Severgnini, MD, PhD
About this study
Interventional Study of Early Postoperative Cognitive Dysfunction in Elderly Patients Undergoing General Anesthesia
The main purpose of this study is to determine the incidence of early postoperative cognitive dysfunction in elderly patients and its time course.
Read more
This study will first evaluate the preoperative cognitive function of elderly patients based on several criteria including complete patient history, laboratory and instrumental exams, and the following measures in order to identify conditions and pathologies that may influence cognitive function.
- Mini Mental State Examination
- Geriatric Index of Comorbidity
- Geriatric Depression Scale
The following neuropsychological tests will be performed on the same day within 7 days of surgery (baseline):
- Trail Making Test B-A
- Digit Span
- Digit Symbol Substitution Test
The three cognitive function assessments will be repeated at the following postoperative time points and the change from the preoperative baseline to each time will be evaluated:
- Day 2 (time point 1)
- Day 4 (time point 2)
- Between days 85 and 90 (time point 3)
If the patient seems confused before the postoperative administration of these tests, the Neecham Confusion Scale will be used to evaluate the patient for the presence of postoperative delirium; if delirium is not detected, the cognitive function tests will be administered.
Read the detailed description
This study has three specific aims:
- To define the frequency of occurrence of early post-operative cognitive dysfunction and its time course.
- To assess risk factors for the onset of post-operative cognitive dysfunction and possible causal factors.
- to compare our results with those from the international literature.
- Conditions
- Postoperative Cognitive Dysfunction
- Being tested
- battery neuropsychological tests
- Keywords
- post-operative cognitive dysfunction, elderly, Mini Mental State Examination, Geriatric Index of Comorbidity, Geriatric Depression Scale, Trail Making Test B-A, Digit Span, Digit Symbol Substitution Test
- Medical subject headings
- Postoperative Cognitive Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
battery neuropsychological testsOther
Also called Mini Mental State Examination,, Geriatric Index of Comorbidity,, Geriatric Depression Scale,, Trail Making Test B-A,
Application of the scores will be on the day 0 (the day before the surgery), day 2 and day 4 (after the surgery).
| Study group | Role | What they receive |
|---|---|---|
| General Anesthesia patients battery neuropsychological tests | Experimental | Mini Mental State Examination, Geriatric Index of Comorbidity, Geriatric Depression Scale, Trail Making Test B-A, Digit Span, Digit Symbol Substitution Test Application of the scores will be on the day 0 (the day before the surgery), day 2 and day 4 (after the surgery). Receives: Other: battery neuropsychological tests |
| Regular recovery patients | Active comparator | Mini Mental State Examination, Geriatric Index of Comorbidity, Geriatric Depression Scale, Trail Making Test B-A, Digit Span, Digit Symbol Substitution Test Application of the scores will be on the day 0 (the day after the hospital admission), day 2 and day 4 (days after the hospital admission). Receives: Other: battery neuropsychological tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
frequency of occurrence of post-operative cognitive dysfunction
we apply specific neuropsychological tests find out post-operative cognitive dysfunction in elderly patients (number of patients 80)
Measured: about 90 days
Secondary outcomes (1)
assess risk factors and causal factors in the onset of post-operative cognitive dysfunction (number of patients 80)
we look for possible risk factors or causal factors in the onset of post-operative cognitive dysfunction considering comorbidity of patients and specific events occurred during anesthesia
Measured: about 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2014 (estimated)
- Study startJan 2014
- Primary completionMay 2017
- Study completionJan 2018 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- First arm of the study considers patients from the operating room with general anesthesia; Second arm of the study considers patients from geriatric regular general ward, without any anesthesia.
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Università degli Studi dell'Insubria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paolo Severgnini, Università degli Studi dell'Insubria
- Investigators
- Severgnini Paolo, MD, PhD, Study director, Università degli Studi dell'Insubria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02068742
- Sponsor's protocol ID
- 1048
- Acronym
- ElderlyPOCD
- Status last verified
- May 2017
- First submitted
- 19 Feb 2014
- Last updated
- 25 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Cognitive Dysfunction in Elderly
- ClinicalTrials.gov ID
- NCT02068742
- Acronym / sponsor ID
- ElderlyPOCD / 1048
- Conditions
- Postoperative Cognitive Dysfunction
- Keywords
- post-operative cognitive dysfunction, elderly, Mini Mental State Examination, Geriatric Index of Comorbidity, Geriatric Depression Scale, Trail Making Test B-A, Digit Span, Digit Symbol Substitution Test
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Università degli Studi dell'InsubriaUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- May 2017 (actual)
- Study completion
- Jan 2018 (estimated)
- First posted
- 21 Feb 2014 (estimated)
- 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.
Interventional Study of Early Postoperative Cognitive Dysfunction in Elderly Patients Undergoing General Anesthesia
The main purpose of this study is to determine the incidence of early postoperative cognitive dysfunction in elderly patients and its time course.
This study will first evaluate the preoperative cognitive function of elderly patients based on several criteria including complete patient history, laboratory and instrumental exams, and the following measures in order to identify conditions and pathologies that may influence cognitive function.
- Mini Mental State Examination
- Geriatric Index of Comorbidity
- Geriatric Depression Scale
The following neuropsychological tests will be performed on the same day within 7 days of surgery (baseline):
- Trail Making Test B-A
- Digit Span
- Digit Symbol Substitution Test
The three cognitive function assessments will be repeated at the following postoperative time points and the change from the preoperative baseline to each time will be evaluated:
- Day 2 (time point 1)
- Day 4 (time point 2)
- Between days 85 and 90 (time point 3)
If the patient seems confused before the postoperative administration of these tests, the Neecham Confusion Scale will be used to evaluate the patient for the presence of postoperative delirium; if delirium is not detected, the cognitive function tests will be administered.
Detailed description
This study has three specific aims:
- To define the frequency of occurrence of early post-operative cognitive dysfunction and its time course.
- To assess risk factors for the onset of post-operative cognitive dysfunction and possible causal factors.
- to compare our results with those from the international literature.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- First arm of the study considers patients from the operating room with general anesthesia; Second arm of the study considers patients from geriatric regular general ward, without any anesthesia.
| Arm | Type | Receives |
|---|---|---|
| General Anesthesia patients battery neuropsychological tests | Experimental | Other: battery neuropsychological testsMini Mental State Examination, Geriatric Index of Comorbidity, Geriatric Depression Scale, Trail Making Test B-A, Digit Span, Digit Symbol Substitution Test Application of the scores will be on the day 0 (the day before the surgery), day 2 and day 4 (after the surgery). |
| Regular recovery patients | Active comparator | Other: battery neuropsychological testsMini Mental State Examination, Geriatric Index of Comorbidity, Geriatric Depression Scale, Trail Making Test B-A, Digit Span, Digit Symbol Substitution Test Application of the scores will be on the day 0 (the day after the hospital admission), day 2 and day 4 (days after the hospital admission). |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Age > 65 years
- Surgery scheduled under general anesthesia, that is expected to last 90 minutes or longer for the arm experimental
Key exclusion criteria (10 listed)
- A score of 20 or less on the Mini-Mental State Examination (MMSE)
- Illiteracy
- Can't understand Italian language
- Serious hearing or vision impairment not treatable
- A history of any disease of the central nervous system
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| battery neuropsychological testsAlso: Mini Mental State Examination,, Geriatric Index of Comorbidity,, Geriatric Depression Scale,, Trail Making Test B-A,Application of the scores will be on the day 0 (the day before the surgery), day 2 and day 4 (after the surgery). | Other | General Anesthesia patients battery neuropsychological tests, Regular recovery patients |
Primary outcome
frequency of occurrence of post-operative cognitive dysfunction
Time frame: about 90 days
we apply specific neuropsychological tests find out post-operative cognitive dysfunction in elderly patients (number of patients 80)
1 secondary outcome
assess risk factors and causal factors in the onset of post-operative cognitive dysfunction (number of patients 80)
Time frame: about 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2017.
Related trials for Postoperative Cognitive Dysfunction
Enrolling by invitationPhase 4
Effects of Ciprofol on Perioperative Neurocognitive Function in Elderly Patients Undergoing Daytime Surgery
PND, POCD - Postoperative Cognitive Dysfunction
Not yet recruitingObservational study
Prospective Observational Multimodal Neuromonitoring During High-Risk Adult Surgery
Postoperative Cognitive Complications, Delirium
Not yet recruitingObservational study
Postsurgical Pain and Opioid Use in Older Adults: Effects of Mild Cognitive Impairment
Mild Cognitive Impairment (MCI), Opioid Use
Not yet recruitingObservational study
Impact of Preoperative Mild Cognitive Impairment on Postoperative Delirium in Patients Undergoing Cardiac Surgery
Neurocognitive Disorder, Cardiac Surgery
RecruitingObservational study
Post Operative Cognitive Dysfunction After Oncologic Surgery
Emergence Delirium, Post-Operative Cognitive Dysfunction
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.
Severgnini Paolo, MD, PhD study director
Università degli Studi dell'Insubria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing battery neuropsychological tests in people with Postoperative Cognitive Dysfunction, run by Università degli Studi dell'Insubria at 1 site in Italy.
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 2 inclusion and 10 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 25 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Severgnini Paolo, MD, PhD (0039033278801, paolo.severgnini@uninsubria.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
frequency of occurrence of post-operative cognitive dysfunction (time frame: about 90 days). 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 25 May 2017.