Modulation of frontal EEG alpha oscillations during maintenance and emergence phases of general anaesthesia to improve early neurocognitive recovery in older patients: protocol for a randomised controlled trial.

Abstract

BACKGROUND:

Postoperative delirium may manifest in the immediate post-anaesthesia care period. Such episodes appear to be predictive of further episodes of inpatient delirium and associated adverse outcomes. Frontal electroencephalogram (EEG) findings of suppression patterns and low proprietary index values have been associated with postoperative delirium and poor outcomes. However, the efficacy of titrating anaesthesia to proprietary index targets for preventing delirium remains contentious. We aim to assess the efficacy of two strategies which we hypothesise could prevent post-anaesthesia care unit (PACU) delirium by maximising the alpha oscillation observed in frontal EEG channels during the maintenance and emergence phases of anaesthesia.

METHODS:

This is a 2 × 2 factorial, double-blind, stratified, randomised control trial of 600 patients. Eligible patients are those aged 60 years or over who are undergoing non-cardiac, non-intracranial, volatile-based anaesthesia of expected duration of more than 2 h. Patients will be stratified by pre-operative cognitive status, surgery type and site. For the maintenance phase of anaesthesia, patients will be randomised (1:1) to an alpha power-maximisation anaesthesia titration strategy versus standard care avoiding suppression patterns in the EEG. For the emergence phase of anaesthesia, patients will be randomised (1:1) to early cessation of volatile anaesthesia and emergence from an intravenous infusion of propofol versus standard emergence from volatile anaesthesia only. The primary study outcomes are the power of the frontal alpha oscillation during the maintenance and emergence phases of anaesthesia. Our main clinical outcome of interest is PACU delirium.

DISCUSSION:

This is a largely exploratory study; the extent to which EEG signatures can be modified by titration of pharmacological agents is not known. The underlying concept is maximisation of anaesthetic efficacy by individualised drug titration to a clearly defined EEG feature. The interventions are already clinically used strategies in anaesthetic practice, but have not been formally evaluated. The addition of propofol during the emergence phase of volatile-based general anaesthesia is known to reduce emergence delirium in children; however, the efficacy of this strategy in older patients is not known.

TRIAL REGISTRATION:

Australian and New Zealand Clinical Trial Registry, ID: 12617001354370 . Registered on 27/09/2017.

• Authors: Amy Gaskell, Rebecca Pullon, Darren Hight, Jonathan Termaat, Gay Mans, Logan Voss, Matthias Kreuzer, Sebastian Schmid, Stephan Kratzer, Amy Rodriguez, Gerhard Schneider, Paul Garcia, Jamie Sleigh
• Journal: Trials (Trials) Vol. 20 Issue 1 Pg. 146 (Feb 22 2019) ISSN: 1745-6215 [Electronic] England
• PMID: 30795794 (Publication Type: Clinical Trial Protocol, Comparative Study, Journal Article)

Topics

• Age Factors
• Alpha Rhythm
• Anesthesia Recovery Period
• Anesthesia, General (adverse effects, methods)
• Brain (drug effects, physiopathology)
• Cognition (drug effects)
• Consciousness (drug effects)
• Delirium (etiology, physiopathology, prevention & control, psychology)
• Double-Blind Method
• Electroencephalography
• Female
• Humans
• Intraoperative Neurophysiological Monitoring (methods)
• Male
• Middle Aged
• New Zealand
• Predictive Value of Tests
• Prospective Studies
• Randomized Controlled Trials as Topic
• Recovery of Function
• Risk Factors
• Time Factors
• Treatment Outcome