Prognostic Factors Associated With Postoperative Cognitive Dysfunction After Surgery

Postoperative Cognitive Dysfunction Clinical Trial

— POCDCOG  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03443440
• Other study ID #: STUDY0000
• Status: Completed
• Start date: April 1, 2018
• Est. completion date: June 6, 2020

Study information

• Verified date: July 2020
• Source: Milton S. Hershey Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: June 6, 2020
• Est. primary completion date: June 6, 2020
• Gender: All
• Age group: 50 Years to 99 Years

Eligibility

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)

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Postoperative Cognitive Dysfunction

Intervention

Other:
• Neurocognitive Testing
neurocognitive testing, computerized

Locations

Country	Name	City	State
United States	Penn State Health Milton S. Hershey Medical Center	Hershey	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.