Clinical trial NCT03443440: Prognostic Factors Associated With Postoperative Cognitive Dysfunction After Surgery
Official title: Delineating Neurocognitive Prognostic Factors Associated With Postoperative Cognitive Dysfunction After General or Neuraxial Anesthesia Utilizing the CogState Brief Battery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Cognitive Dysfunction
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2018-02-23
Enrollment: 57
Sex: ALL
Minimum age (years): 50
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

1. Ability to perform informed consent
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:

1. 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.
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)

Primary outcomes:
measure: Change in performance on the CogState Brief Battery
timeFrame: Change from baseline on the Cogstate Brief Battery score at postoperative Day 30-40.
Secondary outcomes:
measure: Change in performance on the Beck Clinical Depression Inventory (BDI)
timeFrame: Change in baseline on the Beck Clinical Depression Inventory at postoperative Day 30-40.
measure: Change in performance on the Short-Form McGill Pain Questionnaire (SF-MPQ-2)
timeFrame: Change in baseline on the SF-MPQ-2 at postoperative Day 30-40.
measure: Barthel Index of Activities of Daily Living
timeFrame: Change in baseline on the Barthel Index at postoperative Day 30-40.
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Penn State Health Milton S. Hershey Medical Center
state: Pennsylvania
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.