Is Density Spectral Array Display Along With Bispectral Index Superior to the Display of Bispectral Index Alone (DSA-Light)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Awareness During General Anesthesia
• Intervention / Treatment: Device: Depth of anesthesia monitoring using processed EEG

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 Type: Observational
• Enrollment (Estimated): 70

Contacts and Locations

• Study Contact: Name: Michael Boules, MB BCh, FANZCA; Phone Number: +61450506350; Email: michael.boules@health.qld.gov.au
• Study Contact Backup: Name: Victoria Eley, PhD; Phone Number: +6136468111; Email: v.eley@uq.edu.au

Study Locations

• Australia
  • Queensland
    • Herston, Queensland, Australia, 4006
      • Royal Brisbane and Women's Hospital
      • Contact: Christine Woods; Phone Number: +6136468111; Email: ChristineA.Woods@health.qld.gov.au
      • Sub-Investigator: Victoria Eley, PhD
      • Sub-Investigator: Andre Van Zundert, PhD
      • Sub-Investigator: Alison Mudge, PhD
      • Sub-Investigator: Jamie Sleigh, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

• Age ≥ 65 years undergoing elective procedures of 1-3 hours' duration requiring GA at RBWH

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Device: Depth of anesthesia monitoring using processed EEG; Comparison of processed EEG monitor (Bispectral index) with and without Density spectral array

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Collaborators and Investigators

• Sponsor: The University of Queensland
• Collaborators: Medtronic
• Investigators: Principal Investigator: Michael Boules, MB BCh, The University of Queensland

Study record dates

Study Major Dates

• Study Start (Estimated): June 30, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 1, 2029

Study Registration Dates

• First Submitted: August 29, 2025
• First Submitted That Met QC Criteria: November 13, 2025
• First Posted (Actual): November 18, 2025

Study Record Updates

• Last Update Posted (Actual): November 18, 2025
• Last Update Submitted That Met QC Criteria: November 13, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: general anaesthesia; Bispectral index; older adults; EEG; processed EEG; total intravenous anaesthesia; density spectral array; depth of anaesthesia monitoring; patients older than 65 years
• Other Study ID Numbers: 2025/HE000173

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The data collected is owned by Metro North Health and I need their approval before doing so

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes