Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001078549p
Ethics application status
Submitted, not yet approved
Date submitted
27/06/2024
Date registered
5/09/2024
Date last updated
5/09/2024
Date data sharing statement initially provided
5/09/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
DEpth of Anaesthesia in Females – Electroencephalogram biomarkers, Anaesthetic/hormone relationships and Recovery Score: a mechanistic, blinded, non-inferiority randomized controlled trial (DEAF EARS)
Scientific title
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)
Secondary ID [1] 312422 0
Nil known
Universal Trial Number (UTN)
Trial acronym
DEAF EARS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anaesthesia 334238 0
Post-operative quality of recovery 334239 0
Post-operative awareness with recall 334240 0
Condition category
Condition code
Anaesthesiology 330903 330903 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 328928 0
Treatment: Drugs
Comparator / control treatment
Intervention arm B will be the "deep anaesthesia" group. A depth of anaesthesia at BIS 30-35 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.
Control group
Active

Outcomes
Primary outcome [1] 338663 0
The 9-item Quality of Recovery Score
Timepoint [1] 338663 0
Post-operative day 1
Secondary outcome [1] 436921 0
Post-operative nausea and vomiting (PONV)
Timepoint [1] 436921 0
Post-operative care unit visit at 15 min and 60min
Secondary outcome [2] 436922 0
Post-operative recall of events under anaesthesia
Timepoint [2] 436922 0
At 24 hrs and 7 days post-operatively
Secondary outcome [3] 436923 0
Propofol dose for loss of responsiveness
Timepoint [3] 436923 0
At time of induction of anaesthesia
Secondary outcome [4] 437298 0
PONV
Timepoint [4] 437298 0
Post-operative care unit visit at 15 min and 60min
Secondary outcome [5] 437301 0
progesterone level
Timepoint [5] 437301 0
blood sample will be taken on insertion of cannula in anaesthetic bay

Eligibility
Key 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
Minimum age
18 Years
Maximum age
40 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key 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

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Centralised randomisation via the password protected web-based interface, REDCap
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted blocks of size 4
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2025
Actual
Date of last participant enrolment
Anticipated
1/01/2027
Actual
Date of last data collection
Anticipated
10/01/2027
Actual
Sample size
Target
230
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 316835 0
Hospital
Name [1] 316835 0
Department of Anaesthesia, Royal Prince Alfred Hospital
Country [1] 316835 0
Australia
Primary sponsor type
Hospital
Name
Department of Anaesthesia, Royal Prince Alfred Hospital
Address
Country
Australia
Secondary sponsor category [1] 319067 0
None
Name [1] 319067 0
Address [1] 319067 0
Country [1] 319067 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 315603 0
Sydney Local Health District Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 315603 0
https://www.slhd.nsw.gov.au/rpa/research/
Ethics committee country [1] 315603 0
Australia
Date submitted for ethics approval [1] 315603 0
29/07/2024
Approval date [1] 315603 0
Ethics approval number [1] 315603 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 135218 0
Dr Hannah Braithwaite
Address 135218 0
Royal Prince Alfred Hospital, 50 Missenden Rd, Camperdown, NSW, 2050
Country 135218 0
Australia
Phone 135218 0
+61 02 9515 8789
Fax 135218 0
Email 135218 0
[email protected]
Contact person for public queries
Name 135219 0
Hannah Braithwaite
Address 135219 0
Royal Prince Alfred Hospital, 50 Missenden Rd, Camperdown, NSW, 2050
Country 135219 0
Australia
Phone 135219 0
+61 02 9515 8789
Fax 135219 0
Email 135219 0
[email protected]
Contact person for scientific queries
Name 135220 0
Hannah Braithwaite
Address 135220 0
Royal Prince Alfred Hospital, 50 Missenden Rd, Camperdown, NSW, 2050
Country 135220 0
Australia
Phone 135220 0
+61 02 9515 8789
Fax 135220 0
Email 135220 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.