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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)
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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)
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Secondary ID [1]
312422
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Nil known
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Universal Trial Number (UTN)
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Trial acronym
DEAF EARS
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Anaesthesia
334238
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Post-operative quality of recovery
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Post-operative awareness with recall
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Condition category
Condition code
Anaesthesiology
330903
330903
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0
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Anaesthetics
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
328928
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Treatment: Drugs
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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.
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Control group
Active
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Outcomes
Primary outcome [1]
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The 9-item Quality of Recovery Score
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Assessment method [1]
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Quality of Recovery scale questionnaire completed with a study investigator
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Timepoint [1]
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Post-operative day 1
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Secondary outcome [1]
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Post-operative nausea and vomiting (PONV)
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Assessment method [1]
436921
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PONV score post-operatively at 15mins and 60mins in the post-operative care unit
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Timepoint [1]
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Post-operative care unit visit at 15 min and 60min
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Secondary outcome [2]
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Post-operative recall of events under anaesthesia
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Assessment method [2]
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Modified Brice Questionnaire.
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Timepoint [2]
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At 24 hrs and 7 days post-operatively
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Secondary outcome [3]
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Propofol dose for loss of responsiveness
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Assessment method [3]
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Loss of responsiveness to verbal command (“hold up the syringe”) at induction of anaesthesia
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Timepoint [3]
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At time of induction of anaesthesia
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Secondary outcome [4]
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PONV
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Assessment method [4]
437298
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Number of post-operative care unit administered anti-emetics as verified on the electronic medical records
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Timepoint [4]
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Post-operative care unit visit at 15 min and 60min
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Secondary outcome [5]
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progesterone level
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Assessment method [5]
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Blood sampling for progesterone levels from peripheral intravenous cannula
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Timepoint [5]
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blood sample will be taken on insertion of cannula in anaesthetic bay
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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
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Minimum age
18
Years
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Maximum age
40
Years
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Sex
Females
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Can healthy volunteers participate?
Yes
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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
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Centralised randomisation via the password protected web-based interface, REDCap
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted blocks of size 4
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/01/2025
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Actual
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Date of last participant enrolment
Anticipated
1/01/2027
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Actual
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Date of last data collection
Anticipated
10/01/2027
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Actual
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Sample size
Target
230
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Funding & Sponsors
Funding source category [1]
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Hospital
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Name [1]
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Department of Anaesthesia, Royal Prince Alfred Hospital
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Address [1]
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Country [1]
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Australia
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Primary sponsor type
Hospital
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Name
Department of Anaesthesia, Royal Prince Alfred Hospital
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Address
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
319067
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Country [1]
319067
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Ethics approval
Ethics application status
Submitted, not yet approved
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Ethics committee name [1]
315603
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Sydney Local Health District Ethics Review Committee (RPAH Zone)
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Ethics committee address [1]
315603
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https://www.slhd.nsw.gov.au/rpa/research/
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Ethics committee country [1]
315603
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Australia
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Date submitted for ethics approval [1]
315603
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29/07/2024
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Approval date [1]
315603
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Ethics approval number [1]
315603
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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.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Hannah Braithwaite
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Address
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Royal Prince Alfred Hospital, 50 Missenden Rd, Camperdown, NSW, 2050
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Country
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Australia
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Phone
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+61 02 9515 8789
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Hannah Braithwaite
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Address
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Royal Prince Alfred Hospital, 50 Missenden Rd, Camperdown, NSW, 2050
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Country
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Australia
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Phone
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+61 02 9515 8789
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Hannah Braithwaite
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Address
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Royal Prince Alfred Hospital, 50 Missenden Rd, Camperdown, NSW, 2050
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Country
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Australia
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Phone
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+61 02 9515 8789
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Fax
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Email
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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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.
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