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Completed

NCT Number: NCT03443440

Prognostic Factors Associated With Postoperative Cognitive Dysfunction After Surgery

A longitudinal observational study examining preoperative, intraoperative and postoperative factors associated with Postoperative Cognitive Dysfunction in patients older than the age of 50.

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Key information

Conditions

Postoperative Cognitive Dysfunction Cognition Disorders Cognitive Dysfunction Mental Disorders Neurocognitive Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Cognitive Complications Postoperative Complications

Age range

50 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Penn State Health Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Treatment and study plan

Neurocognitive Testing

Other

neurocognitive testing, computerized

Other names: CogState Brief Battery

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

    Test for symptoms of clinical depression. (Scored: 1 to >40 from normal to extreme depression)

  2. 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.

    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)).

  3. Barthel Index of Activities of Daily Living

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

    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)

Sponsors and collaborators

Lead sponsor

Milton S. Hershey Medical Center

Other

Registry information

Official study title

Delineating Neurocognitive Prognostic Factors Associated With Postoperative Cognitive Dysfunction After General or Neuraxial Anesthesia Utilizing the CogState Brief Battery

Acronym: POCDCOG

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Feb 23, 2018
Registry last updated
Jul 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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