Prognostic Factors Associated With Postoperative Cognitive Dysfunction After Surgery (POCDCOG)
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ClinicalTrials.gov Identifier: NCT03443440
Recruitment Status :
First Posted : February 23, 2018
Last Update Posted : July 8, 2020
Milton S. Hershey Medical Center
Information provided by (Responsible Party):
Kunal Karamchandani, Milton S. Hershey Medical Center
A longitudinal observational study examining preoperative, intraoperative and postoperative factors associated with Postoperative Cognitive Dysfunction in patients older than the age of 50.
Condition or disease
Postoperative Cognitive Dysfunction
Other: Neurocognitive Testing
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.
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 Outcome Measures :
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)
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)).
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)
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Layout table for eligibility information
Ages Eligible for Study:
50 Years to 99 Years (Adult, Older Adult)
Sexes Eligible for Study:
Adult population over the age of 50 years old undergoing general, neuraxial or regional anesthesia for elective surgery.
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
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)