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Brain waves vs. the silent risk of waking under the knife

NCT ID NCT07831590

NEW Knowledge-focused Sponsor: Duzce University Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 21, 2026 · Last updated Sep 21, 2026

Summary

Researchers at Duzce University are observing 600 adults scheduled for elective laparoscopic abdominal surgery under general anesthesia. They will track brain-wave activity with a processed EEG monitor and test arm movement with the isolated forearm technique at set points during surgery. The goal is to see whether changes in the EEG signal match moments when a patient might be responsive or aware. Patients also answer recovery and anxiety questionnaires before and after surgery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
processed electroencephalography monitoring with the Masimo SedLine system and the isolated forearm technique
What this could lead to
If brain-wave readings line up with signs of awareness, anesthesiologists could one day use them to adjust drug doses and reduce the chance of patients waking during surgery.
What could go wrong
This is an observational study, so it cannot prove that EEG monitoring prevents awareness. The isolated forearm technique only catches brief moments, and results from 600 planned laparoscopic surgeries may not apply to other operations or patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 600 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2026

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The study population will consist of adult patients aged 18 years or older who are scheduled for elective laparoscopic abdominal surgery under general anesthesia. Patients who meet the predefined inclusion criteria and do not meet any exclusion criteria will be prospectively enrolled. The planned sample size is approximately 600 participants.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age ≥18 years * Elective laparoscopic abdominal surgery planned * General anesthesia planned * Ability to communicate adequately * Adequate cognitive capacity to understand and respond to study procedures * ASA physical status I-III Exclusion Criteria: * Previous cerebrovascular disease * Psychiatric disorders * Cognitive dysfunction * ASA physical status \>III * High frailty * Body mass index \>30 kg/m² * Pregnancy * Age \<18 years

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Conditions

The condition(s) this trial relates to.

Intraoperative Awareness

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Intraoperative awareness Intraoperative responsiveness during general anesthesia

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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  3. A doctor treating you

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Contacts and locations

Locations

  • Duzce University

    RECRUITING

    Düzce, Turkey (Türkiye)

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