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Completed

NCT Number: NCT02650687

Optimizing Postoperative Cognition the Elderly

This study will recruit surgical patients more than 65 years old. Patients who participate will wear a sticker on their forehead during surgery which monitors their brain waves (electroencephalogram, EEG) and participate in memory testing before and after surgery. Brain wave patterns will be compared between patients who have problems with memory and thinking after surgery and those who do not. The hypothesis is that there will be characteristic brain wave patients for who will go on to have problems with memory and thinking after surgery.

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Key information

Conditions

Postoperative Cognitive Dysfunction Cognition Disorders Cognitive Dysfunction Mental Disorders Neurocognitive Disorders POCD Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Cognitive Complications Postoperative Complications

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Icahn School of Medicine at Mount Sinai

New York, 10029, United States

About this study

Eligible patients will be identified through the computerized scheduling system at the Icahn School of Medicine at Mount Sinai. After informed consent, patients will complete cognitive and tests at least one but not more than 30 days prior to surgery. In the recovery room the Post Anesthesia Recovery Scale (PQRS), and CAM-ICU delirium screening will be administered. Immediate recovery will be recorded using the Postoperative Recovery Scale (PQRS) on postoperative day 1 and 3, and 1 week.

Longterm functional recovery will be measured with the Alzheimer's Disease Research Center (ADRC) Instrumental Activities for Daily Living (IADL-24). Postsurgical complications will be recorded including unplanned ICU admissions, postoperative myocardial infarction and stroke (risk less than 1 % in most cases), wound infection and reoperation. The full cognitive and functional battery will be repeated at 3 months and 1 year after surgery.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 65 years of age and older
  • having major elective non-cardiac surgery requiring general anesthesia requiring at least a 2 day hospital stay

Exclusion criteria

  • previous diagnosis of dementia, stroke, cardiac or intracranial surgery
  • inability to consent or communicate in English or Spanish
  • major uncorrected hearing or vision deficit, Parkinson's disease, or major psychiatric disease which will be determined by phone interview and computer medical records abstracted by the primary investigator.

Treatment and study plan

Processed EEG

Procedure

In the operating room. Processed EEG will be measured using the Bispectral Index (BIS) monitor which is standard of care.

Other names: brain waves

Primary outcomes

  1. UDS battery

    Time frame: 3 months

    Postoperative Cognitive Dysfunction - UDS battery is the standard ADRC neuropsychological battery and will be used to measure cognition

Secondary outcomes

  1. Processed EEG

    Time frame: 1 year

    Processed EEG will be measured using the Bispectral Index (BIS) monitor.

  2. CAM-ICU

    Time frame: baseline

    The Confusion Assessment Method-ICU is a delirium screening tool for Intensive Care Unit (ICU) patients, assessing 4 features: alteration/fluctuation in mental status, Inattention, altered level of consciousness, and disorganized thinking.

  3. CAM-ICU

    Time frame: Day 1

    The Confusion Assessment Method-ICU is a delirium screening tool for Intensive Care Unit (ICU) patients, assessing 4 features: alteration/fluctuation in mental status, Inattention, altered level of consciousness, and disorganized thinking.

  4. CAM-ICU

    Time frame: Day 3

    The Confusion Assessment Method-ICU is a delirium screening tool for Intensive Care Unit (ICU) patients, assessing 4 features: alteration/fluctuation in mental status, Inattention, altered level of consciousness, and disorganized thinking.

  5. CAM-ICU

    Time frame: 1 week

    The Confusion Assessment Method-ICU is a delirium screening tool for Intensive Care Unit (ICU) patients, assessing 4 features: alteration/fluctuation in mental status, Inattention, altered level of consciousness, and disorganized thinking.

  6. PQRS

    Time frame: baseline

    Short -Term Recovery: Postoperative Quality of Recovery Scale (PQRS)

  7. PQRS

    Time frame: Day 1

    Short -Term Recovery: Postoperative Quality of Recovery Scale (PQRS)

  8. PQRS

    Time frame: Day 3

    Short -Term Recovery: Postoperative Quality of Recovery Scale (PQRS)

  9. PQRS

    Time frame: 1 week

    Short -Term Recovery: Postoperative Quality of Recovery Scale (PQRS)

  10. UDS battery

    Time frame: 1 year

    Postoperative Cognitive Dysfunction - UDS battery is the standard ADRC neuropsychological battery and will be used to measure cognition

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Jan 8, 2016
Registry last updated
Mar 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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