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| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
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A study to evaluate the use of density spectral array display in comparison with Bispectral index in a clinical setting.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Primary cohort |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Depth of anesthesia monitoring using processed EEG | Device | Comparison of processed EEG monitor (Bispectral index) with and without Density spectral array |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. |
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Inclusion Criteria:
Exclusion criteria:
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• Age ≥ 65 years undergoing elective procedures of 1-3 hours' duration requiring GA at RBWH
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michael Boules, MB BCh, FANZCA | Contact | +61450506350 | michael.boules@health.qld.gov.au | |
| Victoria Eley, PhD | Contact | +6136468111 | v.eley@uq.edu.au |
| Name | Affiliation | Role |
|---|---|---|
| Michael Boules, MB BCh | The University of Queensland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Brisbane and Women's Hospital | Herston | Queensland | 4006 | Australia |
The data collected is owned by Metro North Health and I need their approval before doing so
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