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

ConditionAwareness During General Anesthesia

Trial statusNot yet recruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age65+

SponsorThe University of Queensland

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Administration of ketamine/dexmedetomidine.

Administration of inhaled anaesthetic agents or nitrous oxide

Administration of muscle relaxation

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Depth of anesthesia monitoring using processed EEG
Device
Comparison of processed EEG monitor (Bispectral index) with and without Density spectral array

Treatment groups

70 Participants

are divided into 1 treatment group

Group A: Primary cohort1 intervention

Trial outcomes

Primary outcomes

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.

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

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.

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.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The University of Queensland

Lead sponsor

Medtronic

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: