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Brain wave monitor may reveal hidden pain during surgery

NCT ID NCT06811701

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jul 24, 2026 · Updated 2 times

Summary

This completed study with 120 adults undergoing brain surgery tested whether brain wave patterns and vital signs like blood pressure can show pain from skull pin fixation. Researchers compared three pain management methods: a scalp nerve block, IV opioids, and a local anesthetic injection at the pin site. The goal was to see which method best controls pain and reduces opioid use, using brain wave monitoring as a guide.

What this could mean

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

What this could lead to
If successful, this could help doctors better monitor and manage pain during brain surgery using brain wave analysis.
What could go wrong
This is an observational study, not a treatment trial. It only measures responses, so it won't directly improve pain management yet.

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

120 people

The number who actually took part.

Started

Feb 2025

Finished

Jan 2026

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

"This study will include adult patients undergoing elective craniotomy under general anesthesia. Participants will be assigned to different pain management techniques (scalp nerve block, intravenous opioids, or local anesthetic injection) to evaluate their effects on BIS-DSA spectral analysis and hemodynamic responses.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Adult patients aged 18-70 years undergoing elective craniotomy. * Patients classified as ASA 1-3 according to the American Society of Anesthesiologists (ASA) classification. * Patients scheduled for surgery under general anesthesia. * Patients who provide written informed consent to participate in the study. * Patients with normal cognitive function (i.e., no diagnosed dementia or severe cognitive impairment). * Patients with a preoperative BIS value within the normal range (i.e., no extreme baseline deviations). Exclusion Criteria: * Patients classified as ASA 4 or higher. * Patients with neurological disorders (e.g., Parkinson's disease, epilepsy, stroke history). * Patients with psychiatric disorders (e.g., severe depression, schizophrenia) that may affect pain perception and response. * Patients with known allergies to local anesthetics or opioids. * Pregnant or breastfeeding women. * Patients with contraindications to anesthesia, including but not limited to: * Severe cardiovascular disease (e.g., uncontrolled hypertension, recent myocardial infarction). * Severe respiratory disease (e.g., COPD, uncontrolled asthma). * Patients with any neurological or pharmacological condition that may interfere with BIS-DSA or EEG measurements. * Patients with preoperative chronic opioid use (≥3 months) due to potential tolerance affecting response to intraoperative analgesia. * Patients with a history of substance abuse that may alter the BIS response or anesthetic metabolism. * Patients with significant hearing or communication impairments, preventing them from understanding or responding to preoperative assessments. * Patients with significant scalp pathology (e.g., infections, scars, large vascular malformations) at the BIS electrode placement site, which may interfere with signal acquisition.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • University of Health Sciences Etlik City Hospital

    Ankara, Turkey (Türkiye)

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