ClinicalTrials.gg
CompletedNCT03443440POCDCOGUpdated Jul 8, 2020

Prognostic Factors Associated With Postoperative Cognitive Dysfunction After Surgery

An observational study in Postoperative Cognitive Dysfunction, sponsored by Milton S. Hershey Medical Center. Completed at 1 site in United States. Open to participants aged 50 Years to 99 Years. Per ClinicalTrials.gov, last updated 2020-07-08.

Sponsored by Milton S. Hershey Medical Center · Observational

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Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
57
Ages
50 Years to 99 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 35 studies in Postoperative Cognitive Complications with a site in United States — 6 open to participants now, 7 under way, none of them phase 3. Postoperative Cognitive Complications · United States.

Enrollment
6th of 13
57 · median 41
Started
2018
with 3 others
Observational
13 of 35
2 open now
Registered
20th of 35
by date

Among the 35 studies in Postoperative Cognitive Complications with a site in United States, this one is the 6th largest by enrollment of the 13 observational ones that give a count, is one of 4 that started in 2018, is one of 13 observational ones, and was the 20th registered.

Postoperative Cognitive Complications

260 studies on the registry are indexed under Postoperative Cognitive Complications; 55 are open to participants now.

Browse Postoperative Cognitive Complications studies →

Open to participants now

6 of the 35 studies in Postoperative Cognitive Complications with a site in United States are open now. Recruiting first, the newest first:

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All 6 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 34 Postoperative Cognitive Complications studies recruiting now, 22 (65%) set no upper age limit and 4 (12%) stop at 75 or younger; 2 take children under 18; 6 take healthy volunteers.

This study: 50 Years to 99 Years · all sexes.

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02

Study 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 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.

03

Conditions studied

  • Postoperative Cognitive Dysfunction
04

Who can participate

Ages eligible
50 Years to 99 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Adult population over the age of 50 years old undergoing general, neuraxial or regional anesthesia for elective surgery.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Ability to perform
  2. Age greater than 50 years old
  3. Ability to read and understand English
  4. Undergoing elective surgery with general or neuraxial anesthesia

Exclusion criteria

Exclusion Criteria:

  1. Patients who do not meet above defined criteria, patients from vulnerable populations (adults unable to consent, pregnant women, prisoners), patients refusing and participation in the study.
  2. 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)
  3. Physical impairment impairing their ability to perform neurocognitive testing incl. essential tremor, loss of upper extremity motor function, blindness, or severe hearing loss)
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
57 participants (actual)
Patient registry
No

Interventions

  • OtherNeurocognitive Testing

    neurocognitive testing, computerized

    Also known as: CogState Brief Battery

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Change from baseline on the Cogstate Brief Battery score at postoperative Day 30-40.

Secondary outcomes

  1. 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)

    Time frame: Change in baseline on the Beck Clinical Depression Inventory at postoperative Day 30-40.

  2. 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)).

    Time frame: Change in baseline on the SF-MPQ-2 at postoperative Day 30-40.

  3. 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)

    Time frame: Change in baseline on the Barthel Index at postoperative Day 30-40.

07

Study locations

1 site
  • Penn State Health Milton S. Hershey Medical Center
    Hershey, Pennsylvania 17033, United States
08

References and documents

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 25222138 ↗
  • Bortolato 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 25470396 ↗
  • Harrington 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 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Apr 2018 to primary completion in Jun 2020, 26 months.

Of 76 non-industry observational studies under Postoperative Cognitive Complications, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 65. This study's 26 months is close to that.

Counting every sponsor, half of 76 studies reached it within 27 months; a quarter within 11 and three quarters within 65.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 13, 2018
First posted
Feb 23, 2018
StartActual
Apr 1, 2018
Primary completionActual
Jun 6, 2020
CompletionActual
Jun 6, 2020
Last update
Jul 8, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 8, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03443440
Responsible party
Kunal Karamchandani (Assistant Professor, Dept. of Anesthesiology & Perioperative Medicine, Milton S. Hershey Medical Center) — Principal investigator
First posted
Feb 23, 2018
Start date
Apr 1, 2018
Primary completion
Jun 6, 2020
Completion
Jun 6, 2020
Last update
Jul 8, 2020

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.

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Discussion

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