NCT07561970

Brief Summary

Lower EEG alpha band power is currently extensively studied as a potential biomarker of brain vulnerability. No previous study has evaluated whether there was a difference in EEG power spectrum ranges between propofol and sevoflurane, the two main anesthetic agents for maintenance of general anesthesia, in order to define a cut-off value for the prediction of a higher risk of postoperative delirium.

  • Primary objective: comparison of EEG alpha power (dB) during maintenance of anesthesia with propofol and sevoflurane using data available in the NeuroSense® depth-of-anesthesia monitoring
  • Secondary objectives: comparison of other EEG frequency bands during maintenance of anesthesia with propofol and sevoflurane using data from the NeuroSense® depth-of-anesthesia monitoring

Trial Health

77
On Track

Trial Health Score

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

Enrollment
280

participants targeted

Target at P75+ for not_applicable

Timeline
19mo left

Started Apr 2026

Geographic Reach
1 country

1 active site

Status
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

Study Progress4%
Apr 2026Dec 2027

Study Start

First participant enrolled

April 13, 2026

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

April 17, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 1, 2026

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

May 1, 2026

Status Verified

April 1, 2026

Enrollment Period

1.6 years

First QC Date

April 17, 2026

Last Update Submit

April 24, 2026

Conditions

Keywords

intraoperative electroencephalographyalpha-band power

Outcome Measures

Primary Outcomes (1)

  • Alpha-band power

    Power in decibels from the NeuroWave monitor under general anesthesia

    Intra-operative

Secondary Outcomes (3)

  • Delta-band power

    Intra-operative

  • Thêta-band power

    Intra-operative

  • Bêta-band power

    Intra-operative

Study Arms (2)

Propofol maintenance

ACTIVE COMPARATOR
Other: Maintenance of general anesthesia by Propofol

Sevoflurane maintenance

EXPERIMENTAL
Other: Maintenance of general anesthesia by Sevoflurane

Interventions

Maintenance of general anesthesia for simple electrophysiological procedures

Propofol maintenance

Maintenance of general anesthesia for simple electrophysiological procedures

Sevoflurane maintenance

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Capable to give informed consent
  • French-speaking patients

You may not qualify if:

  • Need for a premedication with benzodiazepine before anesthesia
  • Reduced left ventricular ejection fraction (\< 50%) or underlying cardiac pathology requiring a more balanced anesthesia (administration of benzodiazepine and/or ketamine during anesthesia)
  • Preoperative MoCA score \< 26/30 (for patients \> ou = 55 years old)
  • Patients treated with anti-epileptic drugs
  • Patients treated with benzodiazepines (ex: for anxiolysis or sleep disorders)
  • Emergencies
  • Morbid obesity (BMI \> 40kg/m2)
  • Background of severe postoperative nausea/vomit

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cliniques universitaires Saint-Luc

Brussels, 1200, Belgium

RECRUITING

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2026

First Posted

May 1, 2026

Study Start

April 13, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

May 1, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations