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DEpth of Anaesthesia in Females – Electroencephalogram biomarkers, Anaesthetic/hormone relationships and Recovery Score: a mechanistic, blinded, non-inferiority randomized controlled trial (DEAF EARS)

DEpth of Anaesthesia in Females aged 18 to 40 years – Electroencephalogram biomarkers, Anaesthetic/hormone relationships and Recovery Score: a mechanistic, blinded, non-inferiority randomized controlled trial (DEAF EARS)

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12624001078549
Acronym
DEAF EARS
Enrollment
230
Registered
2024-09-05
Start date
2025-01-01
Completion date
2027-01-01
Last updated
2024-09-09

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

Conditions

None listed

Brief summary

This is a blinded, non-inferiority, randomised control trial, in females aged 18-40 years undergoing general anaesthesia. The primary objective of the study is to determine whether different depths of anaesthesia affect quality of recovery post-operatively. Healthy participants, aged 18-40, will be recruited from surgical lists and enrolled prior to surgery. Data collection will occur intra-operatively, post-operatively in recovery and at 24-hours and 7-days post-operation. We hypothesise that depth of anaesthesia will not affect quality of recovery in young female patients undergoing general anaesthesia.

Interventions

Patients will have a standardised induction with midazolam 0.03mg/Kg, remifentanil 4 ng/ml (Target Controlled Infusion Minto model) and, once target concentration achieved, then propofol 8mcg/ml targeted (Schneider model). The propofol dose (mg administered and predicted effect site concentration) and Bispectral Index (BIS) value will be recorded for loss of verbal responsiveness signified with a syringe drop. Following induction, patients will undergo web-based randomisation to two different

Patients will have a standardised induction with midazolam 0.03mg/Kg, remifentanil 4 ng/ml (Target Controlled Infusion Minto model) and, once target concentration achieved, then propofol 8mcg/ml targeted (Schneider model). The propofol dose (mg administered and predicted effect site concentration) and Bispectral Index (BIS) value will be recorded for loss of verbal responsiveness signified with a syringe drop. Following induction, patients will undergo web-based randomisation to two different approaches to anaesthetic care. Intervention arm A will be the "light anaesthesia" group. A depth of anaesthesia at BIS 45-50 will be targeted using remifentanil (Minto TCI Model) and Propofol (Schneider TCI model) intraoperatively. Remifentanil and propofol will be titrated at the discretion of the treating anaesthetist to achieve the target BIS. BIS EEG data will be extracted and reviewed alongside anaesthesia records to evaluate adherence to intervention.

Sponsors

Department of Anaesthesia, Royal Prince Alfred Hospital
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to 40 Years
Healthy volunteers
Yes

Inclusion criteria

• Adults undergoing non-emergency general anaesthesia • Sex: Female • Age range: 18-40 years old • Healthy [American Society of Anesthesiologists (ASA) grade of physical status ASA 1, 2, or 3] • Willingness to provide informed consent and willingness to participate and comply with the study requirements

Exclusion criteria

• Pregnant women • Participants with a history of a psychological illness or other conditions which may interfere with their ability to understand the study requirements. • Participants with cognitive impairment that is likely to interfere with the evaluation of the participant’s safety and of the study outcome. • Participants requiring rapid sequence induction (RSI) during induction of general anaesthesia

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026