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

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ClinicalTrials.gov Identifier: NCT03443440
Recruitment Status : Recruiting
First Posted : February 23, 2018
Last Update Posted : June 3, 2019
Sponsor:
Information provided by (Responsible Party):
Kunal Karamchandani, Milton S. Hershey Medical Center

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.

Condition or disease Intervention/treatment
Postoperative Cognitive Dysfunction 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.

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Delineating Neurocognitive Prognostic Factors Associated With Postoperative Cognitive Dysfunction After General or Neuraxial Anesthesia Utilizing the CogState Brief Battery
Actual Study Start Date : April 1, 2018
Estimated Primary Completion Date : April 1, 2020
Estimated Study Completion Date : December 1, 2020

Intervention Details:
  • Other: Neurocognitive Testing
    neurocognitive testing, computerized
    Other Name: CogState Brief Battery


Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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)

  2. 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)).

  3. 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)



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Ages Eligible for Study:   50 Years to 99 Years   (Adult, Older Adult)
Sexes 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.
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03443440


Contacts
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Contact: Zyad J Carr, M.D. 717-531-0003 ext 281082 zcarr@pennstatehealth.psu.edu
Contact: Diane E McCloskey, Ph.D. 717-531-6987 dmccloskey@pennstatehealth.psu.edu

Locations
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United States, Pennsylvania
Penn State Health Milton S. Hershey Medical Center Recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Zyad J Carr, MD    717-531-0003 ext 281082    zcarr@pennstatehealth.psu.edu   
Contact: Diane McCloskey, PhD    717-531-0003 ext 280359    dmccloskey@pennstatehealth.psu.edu   
Sponsors and Collaborators
Milton S. Hershey Medical Center

Publications:
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Responsible Party: Kunal Karamchandani, Assistant Professor, Dept. of Anesthesiology & Perioperative Medicine, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT03443440     History of Changes
Other Study ID Numbers: STUDY0000
First Posted: February 23, 2018    Key Record Dates
Last Update Posted: June 3, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders