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Prevention of early post-operative confusion in older people

Modulation of intra-operative EEG in the elderly to prevent early postoperative delirium

Status
Terminated
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12617001354370
Acronym
Alpha-Max
Enrollment
200
Registered
2017-09-27
Start date
2018-02-15
Completion date
2020-09-02
Last updated
2023-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Emergence delirium is a distressing complication of surgery and anaesthesia which is common in the elderly population. It is associated with increased morbidity, mortality, hospital length of stay, discharge to residential care and future cognitive decline. From our previous work we have observed that emergence delirium seems to occur less frequency when alpha activity measured from frontal EEG lead is strong and maintained during emergence from anaesthesia. We plan to conduct a 2 by 2 factorial study to assess the efficacy of 2 interventions which we hope may prevent emergence delirium. Intervention 1 is the use of real-time frontal analysis and anaesthetic and opioid levels to guide anaesthesia to optimise alpha activity. Intervention 2 is the conversion from volatile (gas-based) anaesthesia to propofol anaesthesia for the emergence (waking) phase of anaesthesia. We aim to determine if these interventions are successful in improving the observed alpha activity and subsequently reduce the incidence of emergence delirium in this high risk population

Interventions

2 by 2 factorial design INTERVENTION 1: Active manipulation of volatile anaesthesia and opioid to maximise frontal EEG alpha power. The frontal EEG will be continuously analysed and dose-response curves created during the anaesthetic. These will be used to guide bolus dosing of intravenous fentanyl, an opioid, and to guide the (inhaled) concentration of volatile anaesthesia administered. The bolus doses and maximum and minimum levels will be determined in conjunction with the attending anaes

2 by 2 factorial design INTERVENTION 1: Active manipulation of volatile anaesthesia and opioid to maximise frontal EEG alpha power. The frontal EEG will be continuously analysed and dose-response curves created during the anaesthetic. These will be used to guide bolus dosing of intravenous fentanyl, an opioid, and to guide the (inhaled) concentration of volatile anaesthesia administered. The bolus doses and maximum and minimum levels will be determined in conjunction with the attending anaesthetist and will be based on previous responses in a dynamic process. INTERVENTION 2: Conversion from inhaled volatile to propofol (intravenous) anaesthesia for emergence from anaesthesia. The volatile anaesthesia will be ceased at time of skin closure and propofol will be given by a target controlled infusion to an effect site concentration of 3ug/ml for at least 2 minutes and then ceased for emergence from anaesthesia

Sponsors

University of Auckland
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Factorial
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
60 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Age > 60 years Capacity for informed consent Undergoing non-cardiac, non-intracranial surgery expected to take 2 hours or longer

Exclusion criteria

Inability to consent Chronic pain Deemed unsuitable for study protocol by anaesthetic care provider

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026