Is Density Spectral Array Display Along With Bispectral Index Superior to the Display of Bispectral Index Alone
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Depth of anesthesia monitoring using processed EEG.
- Who it may be relevant to
- Registry conditions: Awareness During General Anesthesia. Basic parameters: from 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Australia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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?
Overview
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.
Interventions
- Device Depth of anesthesia monitoring using processed EEG
Comparison of processed EEG monitor (Bispectral index) with and without Density spectral array
Primary outcome measures
- 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]
- 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.]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- Administration of ketamine/dexmedetomidine.
- Administration of inhaled anaesthetic agents or nitrous oxide
- Administration of muscle relaxation
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Australia · 1 center
- Royal Brisbane and Women's Hospital — Herston
Identifiers
NCT: NCT07232160 · 2025/HE000173