Postoperative Cognitive DysfunctionPOCDCOGNCT03443440
Prognostic Factors Associated With Postoperative Cognitive Dysfunction After Surgery
An observational study of Postoperative Cognitive Dysfunction, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial summary
A longitudinal observational study examining preoperative, intraoperative and postoperative factors associated with Postoperative Cognitive Dysfunction in patients older than the age of 50. Read more about this study
- Who is it for?
- Ages 50 to 99 years
- Conditions the study is for
- Postoperative Cognitive Dysfunction
- What is being tested?
- Neurocognitive Testing
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2018to 6 Jun 2020
- 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 50 to 99 years
- All sexes
- Adult, Older adult
Study population: Adult population over the age of 50 years old undergoing general, neuraxial or regional anesthesia for elective surgery.
Who may be able to join
- Ability to perform informed consent
- Age greater than 50 years old
- Ability to read and understand English
- Undergoing elective surgery with general or neuraxial anesthesia
Who cannot join
- Patients who do not meet above defined criteria, patients from vulnerable populations (adults unable to consent, pregnant women, prisoners), patients refusing informed consent and participation in the study.
- A previous history of the following medical conditions: dementia of any kind (vascular dementia, Alzheimer's disease, organic brain disease with documented cognitive deficits, severe traumatic brain injury, Parkinson's disease, senility)
- Physical impairment impairing their ability to perform neurocognitive testing incl. essential tremor, loss of upper extremity motor function, blindness, or severe hearing loss)
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State Health Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
About this study
Official title: Delineating Neurocognitive Prognostic Factors Associated With Postoperative Cognitive Dysfunction After General or Neuraxial Anesthesia Utilizing the CogState Brief Battery
A longitudinal observational study examining preoperative, intraoperative and postoperative factors associated with Postoperative Cognitive Dysfunction in patients older than the age of 50.
Read the detailed description
A longitudinal observational study examining factors associated with Postoperative Cognitive Dysfunction (POCD) utilizing a computerized neurocognitive battery. In addition, investigators seek to assess the presence of pre-existing psychiatric disorders and chronic pain to determine their relationship with POCD. The study will seek to compare the rates of POCD in previously published literature with performance on a computerized neurocognitive battery. In addition, the study will seek to determine preoperative, intraoperative and postoperative factors associated with POCD by comparing these variables to performance on a computerized neurocognitive battery.
- Conditions
- Postoperative Cognitive Dysfunction
- Being tested
- Neurocognitive Testing
- 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.
Neurocognitive TestingOther
Also called CogState Brief Battery
neurocognitive testing, computerized
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in performance on the CogState Brief Battery
Neurocognitive Test. Detection Task (Score: normal - abnormal), One Card Learning Task (Score: normal - abnormal) One Back Task (Score normal - abnormal) Identification Task (Score normal - Abnormal) Scores are based on normal distributed population data. Scores are measured on a linear scale with no maximum score. Research subjects will also act as their own control based on baseline performance in this longitudinal study.
Measured: Change from baseline on the Cogstate Brief Battery score at postoperative Day 30-40.
Secondary outcomes (3)
Change in performance on the Beck Clinical Depression Inventory (BDI)
Test for symptoms of clinical depression. (Scored: 1 to >40 from normal to extreme depression)
Measured: Change in baseline on the Beck Clinical Depression Inventory at postoperative Day 30-40.
Change in performance on the Short-Form McGill Pain Questionnaire (SF-MPQ-2)
Test of presence of chronic pain (Scored 0-3(severe)) Validates the sensory component of neuropathic or chronic pain, a visual analog scale (Scored: no pain to worst possible pain) and a Present Pain Intensity (Scored: 0-5 (worst)).
Measured: Change in baseline on the SF-MPQ-2 at postoperative Day 30-40.
Barthel Index of Activities of Daily Living
Scale to assess independent function of patient. Components assessing continence, mobility, transfer skills, grooming, hygiene, feeding, bathing, stairs and dressing. (Scored: 0-2, dependent - completely independent) Total Score 0-20 (fully dependent - fully independent)
Measured: Change in baseline on the Barthel Index at postoperative Day 30-40.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2018
- Study start1 Apr 2018
- Primary completion6 Jun 2020
- Study completion6 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kunal Karamchandani, Milton S. Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03443440
- Sponsor's protocol ID
- STUDY0000
- Acronym
- POCDCOG
- Status last verified
- Jul 2020
- First submitted
- 13 Feb 2018
- Last updated
- 8 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Alosco ML, Spitznagel MB, Strain G, Devlin M, Cohen R, Crosby RD, Mitchell JE, Gunstad J. Pre-operative history of depression and cognitive changes in bariatric surgery patients. Psychol Health Med. 2015;20(7):802-13. doi: 10.1080/13548506.2014.959531. Epub 2014 Sep 15.
PubMed 25222138Bortolato B, Carvalho AF, McIntyre RS. Cognitive dysfunction in major depressive disorder: a state-of-the-art clinical review. CNS Neurol Disord Drug Targets. 2014;13(10):1804-18. doi: 10.2174/1871527313666141130203823.
PubMed 25470396Harrington KD, Lim YY, Ames D, Hassenstab J, Rainey-Smith S, Robertson J, Salvado O, Masters CL, Maruff P; AIBL Research Group. Using Robust Normative Data to Investigate the Neuropsychology of Cognitive Aging. Arch Clin Neuropsychol. 2017 Mar 1;32(2):142-154. doi: 10.1093/arclin/acw106.
PubMed 27932344
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Delineating Neurocognitive Prognostic Factors Associated With Postoperative Cognitive Dysfunction After General or Neuraxial Anesthesia Utilizing the CogState Brief Battery
- ClinicalTrials.gov ID
- NCT03443440
- Acronym / sponsor ID
- POCDCOG / STUDY0000
- Conditions
- Postoperative Cognitive Dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 6 Jun 2020 (actual)
- Study completion
- 6 Jun 2020 (actual)
- First posted
- 23 Feb 2018 (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.
A longitudinal observational study examining preoperative, intraoperative and postoperative factors associated with Postoperative Cognitive Dysfunction in patients older than the age of 50.
Detailed description
A longitudinal observational study examining factors associated with Postoperative Cognitive Dysfunction (POCD) utilizing a computerized neurocognitive battery. In addition, investigators seek to assess the presence of pre-existing psychiatric disorders and chronic pain to determine their relationship with POCD. The study will seek to compare the rates of POCD in previously published literature with performance on a computerized neurocognitive battery. In addition, the study will seek to determine preoperative, intraoperative and postoperative factors associated with POCD by comparing these variables to performance on a computerized neurocognitive battery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 to 99 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult population over the age of 50 years old undergoing general, neuraxial or regional anesthesia for elective surgery.
Key inclusion criteria (4 listed)
- Ability to perform informed consent
- Age greater than 50 years old
- Ability to read and understand English
- Undergoing elective surgery with general or neuraxial anesthesia
Key exclusion criteria (3 listed)
- Patients who do not meet above defined criteria, patients from vulnerable populations (adults unable to consent, pregnant women, prisoners), patients refusing informed consent and participation in the study.
- A previous history of the following medical conditions: dementia of any kind (vascular dementia, Alzheimer's disease, organic brain disease with documented cognitive deficits, severe traumatic brain injury, Parkinson's disease, senility)
- Physical impairment impairing their ability to perform neurocognitive testing incl. essential tremor, loss of upper extremity motor function, blindness, or severe hearing loss)
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 |
|---|---|---|
| Neurocognitive TestingAlso: CogState Brief Batteryneurocognitive testing, computerized | Other | – |
Primary outcome
Change in performance on the CogState Brief Battery
Time frame: Change from baseline on the Cogstate Brief Battery score at postoperative Day 30-40.
Neurocognitive Test. Detection Task (Score: normal - abnormal), One Card Learning Task (Score: normal - abnormal) One Back Task (Score normal - abnormal) Identification Task (Score normal - Abnormal) Scores are based on normal distributed population data. Scores are measured on a linear scale with no maximum score. Research subjects will also act as their own control based on baseline performance in this longitudinal study.
3 secondary outcomes
Change in performance on the Beck Clinical Depression Inventory (BDI)
Time frame: Change in baseline on the Beck Clinical Depression Inventory at postoperative Day 30-40.
Change in performance on the Short-Form McGill Pain Questionnaire (SF-MPQ-2)
Time frame: Change in baseline on the SF-MPQ-2 at postoperative Day 30-40.
Barthel Index of Activities of Daily Living
Time frame: Change in baseline on the Barthel Index at postoperative Day 30-40.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2020.
- Background: PubMed 25222138Alosco ML, Spitznagel MB, Strain G, Devlin M, Cohen R, Crosby RD, Mitchell JE, Gunstad J. Pre-operative history of depression and cognitive changes in bariatric surgery patients. Psychol Health Med. 2015;20(7):802-13. doi: 10.1080/13548506.2014.959531. Epub 2014 Sep 15.
- Background: PubMed 25470396Bortolato B, Carvalho AF, McIntyre RS. Cognitive dysfunction in major depressive disorder: a state-of-the-art clinical review. CNS Neurol Disord Drug Targets. 2014;13(10):1804-18. doi: 10.2174/1871527313666141130203823.
- Background: PubMed 27932344Harrington KD, Lim YY, Ames D, Hassenstab J, Rainey-Smith S, Robertson J, Salvado O, Masters CL, Maruff P; AIBL Research Group. Using Robust Normative Data to Investigate the Neuropsychology of Cognitive Aging. Arch Clin Neuropsychol. 2017 Mar 1;32(2):142-154. doi: 10.1093/arclin/acw106.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Cognitive Dysfunction, run by Milton S. Hershey Medical Center at 1 site in United States.
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 3 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: finished, as of the sponsor's last update on 8 Jul 2020. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in performance on the CogState Brief Battery (time frame: Change from baseline on the Cogstate Brief Battery score at postoperative Day 30-40.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03443440, which also lists 3 linked publications.
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 8 Jul 2020.