Awareness During General AnesthesiaDSA-LightNCT07232160
Is Density Spectral Array Display Along With Bispectral Index Superior to the Display of Bispectral Index Alone
An observational study of Awareness During General Anesthesia, run by The University of Queensland at 1 site in Australia.
Trial summary
A study to evaluate the use of density spectral array display in comparison with Bispectral index in a clinical setting. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Awareness During General Anesthesia
- What is being tested?
- Depth of anesthesia monitoring using processed EEG
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 70 participants
- Where
- 1 siteAustralia
- Study dates
- 30 Jun 2026to Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: • Age ≥ 65 years undergoing elective procedures of 1-3 hours' duration requiring GA at RBWH
Who may be able to join
- Age ≥ 65 years undergoing elective procedures of 1-3 hours' duration requiring GA.
- Procedures in which a DoA monitor can be applied to the forehead.
- Patients receiving intravenous propofol and opiate anaesthesia using supraglottic airway device.
- Patient able to provide informed consent.
Who cannot join
- Administration of ketamine/dexmedetomidine.
- Administration of inhaled anaesthetic agents or nitrous oxide
- Administration of muscle relaxation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site
Royal Brisbane and Women's Hospital
Herston, Queensland, 4006
Christine Woods, +6136468111, ChristineA.Woods@health.qld.gov.au
Victoria Eley, PhD
About this study
Official title: Is DSA Display Along With Bispectral Index Superior to the Display of Bispectral Index Alone in Detecting Emergence From Propofol and Opiate Anesthesia? A Prospective Observational Study in Patients Older Than 65 Years?
A study to evaluate the use of density spectral array display in comparison with Bispectral index in a clinical setting.
Read the detailed description
Propofol-based total intravenous anesthesia (TIVA) is a popular general anesthesia (GA) technique with an increased risk of unintended awareness under GA, which can be a devastating and life-changing complication. Age-related changes may impact the performance of EEG-derived depth of anesthesia indices in those older than 65 years, particularly in the presence of cognitive disorders.
Hypothesis: In comparison to monitor 1 (BIS only), monitor 2 (DSA + BIS) will have higher sensitivity and specificity to detect recovery
Objectives:
Investigators will prospectively measure the sensitivity and specificity of monitor 1 versus monitor 2 in patients older than 65 years receiving propofol-based TIVA.
Methods:
Investigators will recruit 70 participants from the Royal Brisbane and Women's Hospital (RBWH) who are aged 65 years or older and scheduled for elective endovascular or endoscopic urologic procedures.
Investigators aim to determine whether the display of DSA can enhance the sensitivity and specificity of depth of anesthesia monitors in detecting sudden changes in anesthetic depth in older patients. This may enhance the detection of inadequate administration or delivery of propofol and may lower the incidence of unintended awareness under general anesthesia in that age group.
- Conditions
- Awareness During General Anesthesia
- Being tested
- Depth of anesthesia monitoring using processed EEG
- Keywords
- depth of anaesthesia monitoring, processed EEG, EEG, density spectral array, Bispectral index, older adults, patients older than 65 years, general anaesthesia, total intravenous anaesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Depth of anesthesia monitoring using processed EEGDevice
Comparison of processed EEG monitor (Bispectral index) with and without Density spectral array
| Study group | Role | What they receive |
|---|---|---|
| Primary cohort | * Age ≥ 65 years undergoing elective procedures of 1-3 hours' duration requiring GA.
* Procedures in which a DoA monitor can be applied to the forehead.
* Patients receiving intravenous propofol and opiate anesthesia using supraglottic airway device.
* Patient able to provide informed consent. Receives: Device: Depth of anesthesia monitoring using processed EEG |
What is being measured
The primary outcome is the main question the study is designed to answer.
aim
Sensitivity and specificity of Bispectral index combined with density spectral array compared with Bispectral index alone in detection of emergence from general anesthesia. Emergence from anaesthesia manifests in changes in the BIS and/or DSA suggestive of a change in the depth of anesthesia and progress towards regaining consciousness.
Measured: In the perioperative period, following the cessation of anesthesia, the patient begins to emerge from a deep anesthetic state to a lighter state and then regains consciousness. The time frame is usually in minutes, but varies depending on various factors
Primary aim
Evaluate the sensitivity and specificity of Bispectral index combined with density spectral array compared with Bispectral index alone in the detection of the timing of emergence from general anesthesia.
Measured: In the perioperative period, time following the cessation of intravenous anesthesia after the procedure; emergence from anesthesia usually takes place over a few minutes to hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2025
- Study start30 Jun 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Awareness During General AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Queensland
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Sponsor
- Investigators
- Michael Boules, MB BCh, Principal investigator, The University of Queensland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07232160
- Sponsor's protocol ID
- 2025/HE000173
- Acronym
- DSA-Light
- Status last verified
- Aug 2025
- First submitted
- 29 Aug 2025
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: The data collected is owned by Metro North Health and I need their approval before doing so
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is DSA Display Along With Bispectral Index Superior to the Display of Bispectral Index Alone in Detecting Emergence From Propofol and Opiate Anesthesia? A Prospective Observational Study in Patients Older Than 65 Years?
- ClinicalTrials.gov ID
- NCT07232160
- Acronym / sponsor ID
- DSA-Light / 2025/HE000173
- Conditions
- Awareness During General Anesthesia
- Keywords
- depth of anaesthesia monitoring, processed EEG, EEG, density spectral array, Bispectral index, older adults, patients older than 65 years, general anaesthesia
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- The University of QueenslandUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- 30 Jun 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 18 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A study to evaluate the use of density spectral array display in comparison with Bispectral index in a clinical setting.
Detailed description
Propofol-based total intravenous anesthesia (TIVA) is a popular general anesthesia (GA) technique with an increased risk of unintended awareness under GA, which can be a devastating and life-changing complication. Age-related changes may impact the performance of EEG-derived depth of anesthesia indices in those older than 65 years, particularly in the presence of cognitive disorders.
Hypothesis: In comparison to monitor 1 (BIS only), monitor 2 (DSA + BIS) will have higher sensitivity and specificity to detect recovery
Objectives:
Investigators will prospectively measure the sensitivity and specificity of monitor 1 versus monitor 2 in patients older than 65 years receiving propofol-based TIVA.
Methods:
Investigators will recruit 70 participants from the Royal Brisbane and Women's Hospital (RBWH) who are aged 65 years or older and scheduled for elective endovascular or endoscopic urologic procedures.
Investigators aim to determine whether the display of DSA can enhance the sensitivity and specificity of depth of anesthesia monitors in detecting sudden changes in anesthetic depth in older patients. This may enhance the detection of inadequate administration or delivery of propofol and may lower the incidence of unintended awareness under general anesthesia in that age group.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Primary cohort | – | Device: Depth of anesthesia monitoring using processed EEG* Age ≥ 65 years undergoing elective procedures of 1-3 hours' duration requiring GA. * Procedures in which a DoA monitor can be applied to the forehead. * Patients receiving intravenous propofol and opiate anesthesia using supraglottic airway device. * Patient able to provide informed consent. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- • Age ≥ 65 years undergoing elective procedures of 1-3 hours' duration requiring GA at RBWH
Key inclusion criteria (4 listed)
- Age ≥ 65 years undergoing elective procedures of 1-3 hours' duration requiring GA.
- Procedures in which a DoA monitor can be applied to the forehead.
- Patients receiving intravenous propofol and opiate anaesthesia using supraglottic airway device.
- Patient able to provide informed consent.
Key exclusion criteria (3 listed)
- Administration of ketamine/dexmedetomidine.
- Administration of inhaled anaesthetic agents or nitrous oxide
- Administration of muscle relaxation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Depth of anesthesia monitoring using processed EEGComparison of processed EEG monitor (Bispectral index) with and without Density spectral array | Device | Primary cohort |
Primary outcome
aim
Time frame: In the perioperative period, following the cessation of anesthesia, the patient begins to emerge from a deep anesthetic state to a lighter state and then regains consciousness. The time frame is usually in minutes, but varies depending on various factors
Sensitivity and specificity of Bispectral index combined with density spectral array compared with Bispectral index alone in detection of emergence from general anesthesia. Emergence from anaesthesia manifests in changes in the BIS and/or DSA suggestive of a change in the depth of anesthesia and progress towards regaining consciousness.
Primary aim
Time frame: In the perioperative period, time following the cessation of intravenous anesthesia after the procedure; emergence from anesthesia usually takes place over a few minutes to hours.
Evaluate the sensitivity and specificity of Bispectral index combined with density spectral array compared with Bispectral index alone in the detection of the timing of emergence from general anesthesia.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
- Individual participant dataSharing planned: Undecided. The data collected is owned by Metro North Health and I need their approval before doing so
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael Boules, MB BCh principal investigator
The University of Queensland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Awareness During General Anesthesia, run by The University of Queensland at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael Boules, MB BCh, FANZCA (+61450506350, michael.boules@health.qld.gov.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
aim (time frame: In the perioperative period, following the cessation of anesthesia, the patient begins to emerge from a deep anesthetic state to a lighter state and then regains consciousness. The time frame is usually in minutes, but varies depending on various factors). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2025.