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Completed

NCT Number: NCT05368272

EEG Spectrogram, Brain Vulnerability and POD

An assessment of difference in prespecified processed electroencephalography variables between cognitively intact older surgical patients who develop postoperative delirium compared to those who do not develop postoperative delirium

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Key information

About this study

Postoperative delirium in older people may be contributed to by intrinsic brain vulnerability such as pre-existing dementia. Some cognitively intact older people also experience postoperative delirium and in these patients some go on to develop later dementia. The investigators propose that postoperative delirium may be an unmasking of covert brain vulnerability by the dyshomeostasis of the anaesthesia/surgical intervention.

In people with dementia or mild cognitive impairment, electroencephalography (EEG) studies have shown slowing of brain wave activity, especially in the back of the brain.

Processed electroencephalography, using a limited number of channels, is routinely used during anaesthesia to aid assessment of anaesthetic depth of the patient.

In this study the investigators will assess the feasibility of acquiring EEG data from the front and back of the brain. The investigators will also explore the data for early signals of brain vulnerability

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • ≥ 65 years old
  • Elective, moderate/major, non-neuro, non-cardiac surgery
  • Ability to give informed consent

Exclusion criteria

  • Preoperative cognitive impairment
  • Current systemic infection
  • Current use of medication that may modify EEG
  • History of neurosurgery/significant head trauma
  • Presence of neurological diseases including overt stroke, dementia, epilepsy, multiple sclerosis, Parkinson's disease, intracranial tumours and other significant neurologic disorders
  • Current significant psychiatric conditions such as severe depression.
  • Palliative surgery

Treatment and study plan

Processed electroencephalography

Other

Acquisition of raw EEG data from processed EEG monitor. Analysis of data acquired for prespecified bandwidth properties

Postoperative delirium assessment

Other

Twice daily assessment for the incidence of postoperative delirium using validated tool (questionnaire)

Primary outcomes

  1. Feasibility of acquiring frontal and posterior EEG data from the Narcotrend monitor during the preoperative and intraoperative period

    Time frame: Approximately 1 - 2 hours per participant

    Feasibility will be assessed by the ability to get preoperative and intraoperative epochs of EEG that clearly demonstrates the different brain wave bands (alpha, theta and delta)

Secondary outcomes

  1. Preoperative brain wave differences

    Time frame: Approximately 10 minutes per participant

    Identify any differences in frontal and posterior narrowband (i.e. alpha, delta and theta) power preoperatively between older people who develop POD compared to those who do not.

  2. Change in brain wave power due to induction of anaesthesia

    Time frame: Approximately 1 hour per particpant

    Identify if the change in narrowband power from the preoperative values to steady state intraoperative values are different between groups (i.e. people who develop POD vs people who do not develop POD)

  3. Intraoperative brain wave patterns

    Time frame: Duration of surgery or 2 hours (shortest option)

    Identify any differences in mean and spectral edge frequencies preoperatively and intraoperatively between older people who develop POD and those who do not.

Sponsors and collaborators

Lead sponsor

University of Nottingham

Other

Registry information

Official study title

EEG Spectrogram to Assess Brain Vulnerability as a Risk Factor for Postoperative Delirium in Older People - a Feasibility Study

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
May 10, 2022
Registry last updated
Feb 28, 2024

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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