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A comparison of methods to detect awareness under anaesthesia for patients undergoing electro-convulsive therapy.

Bispectral index monitoring during ECT: feasibility, failure rates, and pilot incidence estimates of connected consciousness

Status
Completed
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12622000125729
Enrollment
53
Registered
2022-01-27
Start date
2021-10-12
Completion date
2023-03-06
Last updated
2026-08-24

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

Conditions

None listed

Brief summary

Electro-convulsive therapy (ECT) is an effective treatment for major depression. ECT is often more successful and achieves a more rapid result than the use of medications or psychotherapy. ECT works by generating an epileptic seizure so the patient must be given a short general anaesthetic so that they are not aware during the procedure. Anaesthetic drugs have a tendency to suppress the ECT seizure, so it is common practice to use as a low an anaesthetic dose as practical, but the low dose of the anaesthetic drug can lead to an increased risk of awareness under anaesthesia. Despite this increased risk, many institutions take no extra precautions or monitoring for awareness. Others, such as our institution, use an isolated limb technique, where the patient's foot is isolated from the paralysing anaesthetic drugs with a blood pressure cuff so if the patient is still awake they can still communicate by moving their foot and more anaesthetic drug can be given to get the patient back asleep prior to treatment. Brain monitoring to detect awareness is often used in other types of anaesthetics and has been used in small trials for ECT but there are no studies comparing brain monitoring and the isolated limb technique to compare their relative accuracy. Which method is the best for detecting awareness? Our study will compare the exposure of brain monitoring to our isolated limb technique, and have an independent observer record the value on the brain monitor, that way we can see if one technique is a better detector of awareness than the other.

Interventions

For ECT, it is common practice to use as a low an anaesthetic dose as practical as the anaesthetic induction drugs have a tendency to suppress the therapeutic ECT seizure. This leads to an increased risk of awareness under anaesthesia. Despite this increased risk, many institutions take no extra precautions. Others, such as our institution, use an isolated limb technique, where the patient's foot is isolated from the paralysing drugs with a BP cuff so if the patient is still awake they can still

For ECT, it is common practice to use as a low an anaesthetic dose as practical as the anaesthetic induction drugs have a tendency to suppress the therapeutic ECT seizure. This leads to an increased risk of awareness under anaesthesia. Despite this increased risk, many institutions take no extra precautions. Others, such as our institution, use an isolated limb technique, where the patient's foot is isolated from the paralysing drugs with a BP cuff so if the patient is still awake they can still communicate by moving their foot, prior to treatment. The use of Bispectral index (BIS) (EEG brain monitoring to prevent awareness under anaesthesia is in common use in other areas of anaesthesia) has been described for ECT but there are no papers comparing BIS and isolated limb technique or their comparative accuracy. Our exposure will be to add a BIS monitoring to our standard isolated limb technique, and have an independent observer record the value on the BIS monitor and the presence or absence of foot movement to voice command just prior to the ECT treatment. ECT procedures typically take 20-30 mins from when the patient wheels into operating theatre to wheels out. The actual anaesthetic and ECT treatment take around 10-15 mins, with the rest of the time need for setup. This trial is not expected to increase the time per procedure as the BIS electrodes can be attached by the anaesthetist in parallel with the psychiatrist attaching the ECT electrodes. It is anticipated the majority of patients enrolled in the trial will have a single treatment observed but some may have more than one treatment session observed, the frequency of which is determined by whatever their normal treatment schedule is. For example, some patients receive fortnightly or monthly maintenance ECT, in which case they would be observed fortnightly, or monthly. Some patients receive higher frequency, for example ECT every second day. The trial does not determine in anyway how often the patient receives ECT, it only observes them during their normal treatment. The observation will be performed members of the trial team, either Dr Mackenzie, or Dr Allysan Armstrong-Brown, (both trained in Anaesthesia) who will be in the operating theatre observing. In addition, the patient will have their own treating Anaesthetist who is blinded to the BIS scores, and will be looking after their ECT patient as they normally would.

Sponsors

Calvary Mater Newcastle
Lead SponsorHospital

Eligibility

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

Inclusion criteria

Individuals having voluntary ECT at Calvary Mater Hospital Newcastle Individuals having ECT for major depressive disorder

Exclusion criteria

Indication for ECT other than major depressive disorder, including schizophrenia, schizoaffective disorder, bipolar disorder, catatonia, active psychosis Treatment with anti-epileptic medication

Outcome results

None listed

Source: ANZCTR · Data processed: Aug 31, 2026