NCT03443440

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 13, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 23, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2018

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 6, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 6, 2020

Completed
Last Updated

July 8, 2020

Status Verified

July 1, 2020

Enrollment Period

2.2 years

First QC Date

February 13, 2018

Last Update Submit

July 7, 2020

Conditions

Postoperative Cognitive Dysfunction

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Change in performance on the Beck Clinical Depression Inventory (BDI)

    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)

    Change in baseline on the SF-MPQ-2 at postoperative Day 30-40.

  • Barthel Index of Activities of Daily Living

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

Interventions

Neurocognitive TestingOTHER

neurocognitive testing, computerized

Also known as: CogState Brief Battery

Eligibility Criteria

Age50 Years - 99 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult population over the age of 50 years old undergoing general, neuraxial or regional anesthesia for elective surgery.

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Penn State Health Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Related 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.

    PMID: 25222138BACKGROUND

  • 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.

    PMID: 25470396BACKGROUND

  • 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.

    PMID: 27932344BACKGROUND

MeSH Terms

Conditions

Postoperative Cognitive Complications

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsCognitive DysfunctionCognition DisordersNeurocognitive DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Dept. of Anesthesiology & Perioperative Medicine

Study Record Dates

First Submitted

February 13, 2018

First Posted

February 23, 2018

Study Start

April 1, 2018

Primary Completion

June 6, 2020

Study Completion

June 6, 2020

Last Updated

July 8, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)