NCT07232160

Is Density Spectral Array Display Along With Bispectral Index Superior to the Display of Bispectral Index Alone

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?

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 70 (estimated)
• Sponsor: The University of Queensland · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Awareness During General Anesthesia

Interventions

Type	Name	Description
DEVICE	Depth of anesthesia monitoring using processed EEG	Comparison of processed EEG monitor (Bispectral index) with and without Density spectral array

Timeline

• Start date: 2026-06-30
• Primary completion: 2028-12-31
• Completion: 2029-12-01
• First posted: 2025-11-18
• Last updated: 2025-11-18

Locations

1 site across 1 country: Australia

Regulatory

• FDA-regulated device study