Clinical trial NCT05368272: EEG Spectrogram, Brain Vulnerability and POD
Official title: EEG Spectrogram to Assess Brain Vulnerability as a Risk Factor for Postoperative Delirium in Older People - a Feasibility Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Delirium
Keywords: processed EEG
Postoperative vulnerability
Older people
Brain vulnerability
Lead sponsor: University of Nottingham
Sponsor class: OTHER
First posted: 2022-05-10
Enrollment: 30
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Older people scheduled for elective major surgery at a large teaching hospital

Brief summary: 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

Detailed description: 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

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of acquiring frontal and posterior EEG data from the Narcotrend monitor during the preoperative and intraoperative period
timeFrame: Approximately 1 - 2 hours per participant
Secondary outcomes:
measure: Preoperative brain wave differences
timeFrame: Approximately 10 minutes per participant
measure: Change in brain wave power due to induction of anaesthesia
timeFrame: Approximately 1 hour per particpant
measure: Intraoperative brain wave patterns
timeFrame: Duration of surgery or 2 hours (shortest option)
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Queen's Medical Centre
Study officials:
affiliation: University of Nottingham
name: Iain Moppett, FRCA, MD
role: PRINCIPAL_INVESTIGATOR
References: