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Completed

NCT Number: NCT04189861

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

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.

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Key information

Age range

60 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Primary outcomes

  1. Postoperative Cognitive Decline

    Time frame: 3 months postoperatively

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

Secondary outcomes

  1. Effective and Functional Connectivity

    Time frame: 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 outcomes

  1. Postoperative Delirium

    Time frame: Postoperative days 2-7

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

Sponsors and collaborators

Lead sponsor

Dartmouth-Hitchcock Medical Center

Other

Registry information

Official study title

The Role of Brain Wave Monitoring in Reducing the Incidence of Postoperative Cognitive Dysfunction

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Dec 6, 2019
Registry last updated
Jan 14, 2026

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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