NCT07031427

Brief Summary

The electroencephalogram (EEG) measures brain waves during general anaesthesia via an electrode placed on the forehead. These brain waves show the different stages of natural sleep as well as the state of the brain when a patient is put under general anaesthesia for an operation. In this research project, the investigators aim to find out if the EEG signal shows slow wave activity (where an EEG wave repeats every 10 to 1 seconds) just before the onset of the burst suppression pattern, where the EEG waveform alternates between very small (suppression) and very large (burst) signals over a period of a few seconds. It is not currently known if and how often this occurs, but if it does, it would be a useful signal to help anaesthetists administer just the right dose of anaesthesia to patients.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2025

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 12, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 22, 2025

Completed
9 days until next milestone

Study Start

First participant enrolled

July 1, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

June 27, 2025

Status Verified

June 1, 2025

Enrollment Period

5 months

First QC Date

June 12, 2025

Last Update Submit

June 23, 2025

Conditions

Keywords

Electroencephalogram (EEG)General AnesthesiaBurst SuppressionDelta powerSlowwave power

Outcome Measures

Primary Outcomes (1)

  • Slowwave Peak Amplitudes prior to Burst Suppression

    The primary variables of interest are peak amplitudes in the slow wave signal and absolute power in the EEG frequency spectra when recorded from immediately prior to the onset of burst suppression.

    This outcome is measured during the anesthesia for surgery, i.e., between when a patient is anaesthetised until they wake up following the operation, all on the same day.

Study Arms (1)

Patients over 60 requiring general anesthesia

The group in focus in this study are patients aged over 60 requiring general anesthesia for elective surgery

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients requiring elective surgery at either the Cantonal Hospital of Aarau, Switzerland, or at the Hirslanden Clinic Aarau, Switzerland.

You may qualify if:

  • patients undergoing elective general anaesthesia, and
  • aged 60 or above, and
  • have a good comprehension of German, and
  • require a general anaesthesia length of at least 1 hour (to ensure that we can record enough good quality EEG signal).

You may not qualify if:

  • patients undergoing head or neck surgery or surgery in prone or lateral decubitus position (due to the limited placement space on the forehead required for the two EEG electrode systems, limited access to the forehead during surgery), or
  • patients undergoing emergency surgery, operations only requiring local or regional anaesthesia with sedation, or
  • patients who cannot follow procedures, or have an inability to give consent, or
  • known participation in another human research project (ClinO/HRO) that may affect the objectives of this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hirslanden Clinic Aarau

Aarau, Aagrau, 5001, Switzerland

Location

Cantonal Hospital of Aarau

Aarau, Canton of Aargau, 5001, Switzerland

Location

Related Publications (3)

  • Ma K, Bebawy JF. Electroencephalographic Burst-Suppression, Perioperative Neuroprotection, Postoperative Cognitive Function, and Mortality: A Focused Narrative Review of the Literature. Anesth Analg. 2022 Jul 1;135(1):79-90. doi: 10.1213/ANE.0000000000005806. Epub 2021 Dec 6.

    PMID: 34871183BACKGROUND
  • Gutierrez R, Purdon PL. Phase-amplitude coupling during maintenance of general anaesthesia: towards a better understanding of anaesthetic-induced brain dynamics in children. Br J Anaesth. 2023 Sep;131(3):439-442. doi: 10.1016/j.bja.2023.06.030. Epub 2023 Aug 4.

    PMID: 37611972BACKGROUND
  • Chen J, Li W, Chen Q, Zhou Z, Chen C, Hu Y, Si Y, Zou J. Optimizing anesthesia management based on early identification of electroencephalogram burst suppression risk in non-cardiac surgery patients: a visualized dynamic nomogram. Ann Med. 2024 Dec;56(1):2407067. doi: 10.1080/07853890.2024.2407067. Epub 2024 Sep 24.

    PMID: 39317392BACKGROUND

Central Study Contacts

Darren Hight, PhD.

CONTACT

Study Design

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

Study Record Dates

First Submitted

June 12, 2025

First Posted

June 22, 2025

Study Start

July 1, 2025

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

June 27, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

The investigators have chosen not to share as most data we collect is sensitive patient data requiring protection.

Locations