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

July 7, 2020 updated by: Kunal Karamchandani, Milton S. Hershey Medical Center

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
57

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Change from baseline on the Cogstate Brief Battery score at postoperative Day 30-40.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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 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)
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)).
Change in baseline on the SF-MPQ-2 at postoperative Day 30-40.
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)
Change in baseline on the Barthel Index at postoperative Day 30-40.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Milton S. Hershey Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2018

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 6, 2020

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 6, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 13, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 21, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 23, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 8, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 7, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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