An observational study in Electroencephalography, Craniotomy Surgery and Pain Management, sponsored by Diskapi Teaching and Research Hospital. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-25.
Sponsored by Diskapi Teaching and Research Hospital · Observational
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.
Adult patients undergoing elective craniotomy under general anesthesia will be evaluated. Methods used to manage pin-related pain will be categorized into three approaches: intravenous opioids, local Methods used to manage pin-related pain will be categorised into three approaches: intravenous opioids, local anaesthetic injection at the pin site, and scalp block. injection at the pin site, and scalp block. The patient's The patient's haemodynamic responses and reactions to painful stimuli recorded by the BIS-DSA monitor during skull clamp placement will be documented. responses and reactions to painful stimuli recorded by the BIS-DSA monitor during skull clamp placement will be documented. These records are automatically archived in the BIS-DSA device.Waveform data will be converted into numerical values using a predefined hue-based algorithm.
1,190 studies on the registry are indexed under Agnosia; 508 are open to participants now.
This study's enrollment of 120 is close to the median of 120 across 147 observational studies indexed under Agnosia.
Browse Agnosia studies →Diskapi Teaching and Research Hospital is the lead sponsor of 101 studies on the registry; 13 are open to participants now.
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"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.
Exclusion Criteria:
"This group consists of patients who receive a scalp nerve block for pain management during skull pin fixation."
Procedure: Scalp nerve block
"This group consists of patients who receive intravenous opioids for pain management during skull pin fixation."
Drug: Opioid Anesthetics
"This group consists of patients who receive a local anesthetic injection at the pin site before skull pin fixation."
Procedure: Local Anesthetic Injection
Patient in this group will receive a scalp nerve block using bupivacaine before skull pin fixation to manage to pain.
Also known as: Scalp nerve block with bupivacaine
Patient in this group will receive IV opioid for pain management before skull pin fixation
Also known as: IV fentanyl
"Patients in this group will receive a local anesthetic (such as lidocaine) injection at the pin site before skull pin fixation.
Also known as: Lidocaine injection at pin site
Changes in BIS-DSA spectral analysis before and after skull pin fixation
The primary outcome measure will be the changes in brain wave activity, specifically in the BIS-DSA spectral analysis, before and after skull pin fixation. This will be assessed by comparing the pre- and post-fixation BIS values and spectral features such as alpha dropout, beta arousal, and delta changes
Time frame: From baseline (before skull pin fixation) to 5 minutes after skull pin fixation.
Changes in Mean Arterial Pressure (MAP) before and after skull pin fixation
Hemodynamic response will be evaluated by measuring changes in mean arterial pressure before and after skull pin fixation.
Time frame: Baseline to 5 minutes after skull pin fixation.
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Diskapi Teaching and Research Hospital