Use of Brain Wave Monitoring During Surgery to Reduce Postoperative Cognitive Dysfunction

Sponsor
Dartmouth-Hitchcock Medical Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT04189861
Collaborator
(none)
100
1
47.2
2.1

Study Details

Study Description

Brief Summary

This research study is being done to determine if indices derived from monitoring brain wave activity while under general anesthesia will predict the likelihood of post-operative cognitive dysfunction in patients over 60 years old.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Postoperative cognitive dysfunction (POCD) occurs in 30-40% of older adults after undergoing surgical procedures. POCD be subtle, such as a formerly avid reader unable to read for comprehension, to more overt, such as the inability to perform self-care. This deterioration in cognitive function leads to increased mortality, premature departure from the labor market and economic hardship. With 25 million people over the age of 60 undergoing surgical procedures annually in the United States and most of them living long into their 8th decade, prevention of POCD is an important public health issue.

    The causal mechanism of POCD remains unclear, though older patients who receive general anesthesia are at increased risk relative to younger patients. While the association between age and POCD is not fully understood, several normal, age-related changes to brain anatomy and physiology may explain the increased susceptibility. These include decreased brain volume, notably in the prefrontal cortex, cortical thinning and altered neurotransmitter function. Taken together, these changes decrease the anesthetic requirements for older patients to achieve a similar anesthetic state and make them susceptible to overdosing of anesthetic agents. This is supported by studies using electroencephalography (EEG) to measure cerebral cortical activity which have demonstrated profound age-related differences for patients receiving general anesthesia. Older patients are more likely to develop burst suppression, an EEG pattern associated with an excessive anesthetic state. Currently, a major limitation in the field is the absence of studies that have used raw EEG data to examine the association between the dosing of anesthetic agents and POCD in older patients. Although prior studies have used EEG-derived depth of anesthesia indices to explore this association, these indices have been shown to be an unreliable measure of anesthetic state in older patients. Thus, the question of whether an excessive anesthetic state in this population causes POCD remains unanswered.

    The investigators will recruit 100 adults over 60 years of age who undergo elective surgery under general anesthesia with EEG monitoring. A brief neurocognitive test battery will be conducted before surgery, 3-7 day post-surgery, and 3 months post-surgery to assess the association between EEG suppression and POCD.

    In this study, the investigators hypothesize that the duration of EEG suppression is associated with POCD.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    The Role of Brain Wave Monitoring in Reducing the Incidence of Postoperative Cognitive Dysfunction
    Actual Study Start Date :
    Jan 24, 2020
    Anticipated Primary Completion Date :
    Jan 1, 2023
    Anticipated Study Completion Date :
    Jan 1, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Postoperative Cognitive Decline [3 months postoperatively]

      The investigators will use a Composite Cognitive Change Score (between baseline and 3 months) to determine POCD

    Secondary Outcome Measures

    1. Effective and Functional Connectivity [Day of surgery]

      The investigators will use a multi-channel EEG (standard 10-20 montage) to assess changes to effective and functional connectivity during general anesethesia

    Other Outcome Measures

    1. Postoperative Delirium [Postoperative days 2-7]

      The investigators will use CAM-ICU to screen for postoperative delirium

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    60 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • 60-80 years of age who present for elective, non-cardiac surgical procedure requiring general anesthesia and an anticipated two-day or longer inpatient hospital stay

    • English as the native and primary language

    • Presence of an informant who has had weekly contact with the participant for at least the last year

    • Participant is capable of providing written informed consent.

    Exclusion Criteria:
    • history of persistent and severe mental illness (e.g., schizophrenia, bipolar disorder)

    • neurological disorder (e.g., Parkinson's disease, epilepsy, stroke)

    • active substance use disorder as defined by the Diagnostic and Statistical Manual Diploma in Social Medicine(DSM-V)

    • history of prior diagnosis of learning disability per the DSM-V

    • estimated premorbid intellectual functioning below a scaled score of 70 based on the Test of Premorbid Functioning (TOPF)

    • severe visual or hearing impairments that prevent the participant from undergoing the neurocognitive assessment.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Dartmouth-Hitchcock Medical Center Lebanon New Hampshire United States 03756

    Sponsors and Collaborators

    • Dartmouth-Hitchcock Medical Center

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Myles D. Boone, MD MPH, Staff Physician, Anesthesiology, Dartmouth-Hitchcock Medical Center
    ClinicalTrials.gov Identifier:
    NCT04189861
    Other Study ID Numbers:
    • D19171
    First Posted:
    Dec 6, 2019
    Last Update Posted:
    Jul 12, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 12, 2022