Electroencephalography, Craniotomy Surgery, Pain Management
Conditions
Keywords
depth of anaesthesia, Bispectral index-Density Spectral array, skull clamp pain, noxious
Brief 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.
Detailed description
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.
Interventions
PROCEDUREScalp nerve block
Patient in this group will receive a scalp nerve block using bupivacaine before skull pin fixation to manage to pain.
Patient in this group will receive IV opioid for pain management before skull pin fixation
PROCEDURELocal Anesthetic Injection
"Patients in this group will receive a local anesthetic (such as lidocaine) injection at the pin site before skull pin fixation.
Sponsors
Diskapi Teaching and Research Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in BIS-DSA spectral analysis before and after skull pin fixation | From baseline (before skull pin fixation) to 5 minutes 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Mean Arterial Pressure (MAP) before and after skull pin fixation | Baseline to 5 minutes after skull pin fixation. | Hemodynamic response will be evaluated by measuring changes in mean arterial pressure before and after skull pin fixation. |
Countries
Turkey (Türkiye)
Contacts
PRINCIPAL_INVESTIGATORCeyda Ozhan Caparlar, MD
Ankara Etlik City Hospital
Outcome results
None listed