CompletedNot Applicable

Evaluation of Response to Pain From Skull Pin Fixation in Craniotomies

Turkey (Türkiye)120 participantsStarted 2025-02-28

Plain-language summary

The goal of this observational study is to investigate the relationship between the response to skull pin fixation pain and the analysis of blood pressure, heart rate, and brain wave activity in adults undergoing brain surgery. The main questions it aims to answer are: Does the analysis of blood pressure, heart rate, and brain wave activity indicate the patient's response to skull pin fixation pain during brain surgery? How do the methods used to reduce skull pin fixation pain in brain surgeries affect narcotic opioid consumption? The researchers will monitor the patients' response to skull pin fixation pain during surgery through the analysis of brain wave activity.

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 anest…

Questions worth asking your doctor

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1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

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Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Changes in BIS-DSA spectral analysis before and after skull pin fixation

Timeframe: From baseline (before skull pin fixation) to 5 minutes after skull pin fixation.

Trial details

NCT IDNCT06811701

SponsorDiskapi Teaching and Research Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-10-30

View on ClinicalTrials.gov More Electroencephalography trials