EEG Spectrogram, Brain Vulnerability and POD

Completed

• Conditions: Postoperative Delirium

• Registration Number: NCT05368272
• Lead Sponsor: University of Nottingham

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

Study Timeline

• Study First Submitted: 2022-05-05
• Study First Submitted QC: 2022-05-05
• Study First Posted: 2022-05-10
• Study Start: 2023-01-27
• Primary Completion: 2023-12-06
• Study Completion: 2023-12-06
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-26
• Last Update Posted: 2024-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Feasibility of acquiring frontal and posterior EEG data from the Narcotrend monitor during the preoperative and intraoperative period	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 Outcome Measures

Name	Time	Method
Preoperative brain wave differences	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.
Change in brain wave power due to induction of anaesthesia	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)
Intraoperative brain wave patterns	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.

Trial Locations

Locations (1)

Queen's Medical Centre; 🇬🇧 Nottingham, United Kingdom