Prognostic Factors Associated With Postoperative Cognitive Dysfunction After Surgery (POCDCOG)

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Cognitive Dysfunction
• Intervention / Treatment: Other: Neurocognitive Testing

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 Type: Observational
• Enrollment (Actual): 57

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 99 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: 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.

Description

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)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Change from baseline on the Cogstate Brief Battery score at postoperative Day 30-40.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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)).	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)	Change in baseline on the Barthel Index at postoperative Day 30-40.

Collaborators and Investigators

• Sponsor: Milton S. Hershey Medical Center

Publications and helpful links

General 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2018
• Primary Completion (ACTUAL): June 6, 2020
• Study Completion (ACTUAL): June 6, 2020

Study Registration Dates

• First Submitted: February 13, 2018
• First Submitted That Met QC Criteria: February 21, 2018
• First Posted (ACTUAL): February 23, 2018

Study Record Updates

• Last Update Posted (ACTUAL): July 8, 2020
• Last Update Submitted That Met QC Criteria: July 7, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Postoperative Complications; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction; Postoperative Cognitive Complications
• Other Study ID Numbers: STUDY0000

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No