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

NCT07232160 | Not Yet Recruiting FDA Device

• 1 other identifier: 2025/HE000173
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

A study to evaluate the use of density spectral array display in comparison with Bispectral index in a clinical setting.

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; total intravenous anaesthesia

Outcome Measures

Primary Outcomes (2)

• 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.

Study Arms (1)

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

Interventions

Depth of anesthesia monitoring using processed EEG DEVICE

Comparison of processed EEG monitor (Bispectral index) with and without Density spectral array

Primary cohort

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• Administration of ketamine/dexmedetomidine.
• Administration of inhaled anaesthetic agents or nitrous oxide
• Administration of muscle relaxation

Sponsors & Collaborators

• The University of Queensland: lead
• Medtronic: collaborator

Study Sites (1)

Royal Brisbane and Women's Hospital

Herston, Queensland, 4006, Australia

Location

Study Officials

• Michael Boules, MB BCh

  The University of Queensland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Boules, MB BCh, FANZCA

CONTACT

+61450506350; michael.boules@health.qld.gov.au

Victoria Eley, PhD

CONTACT

+6136468111; v.eley@uq.edu.au

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2025
• First Posted: November 18, 2025
• Study Start (Estimated): June 30, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 1, 2029
• Last Updated: November 18, 2025

Record last verified: 2025-08

Locations

AU (1)