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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Scalp group | "This group consists of patients who receive a scalp nerve block for pain management during skull pin fixation." |
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| Group 2: Opioid Group | "This group consists of patients who receive intravenous opioids for pain management during skull pin fixation." |
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| Group 3: Local Anesthetic Group | "This group consists of patients who receive a local anesthetic injection at the pin site before skull pin fixation." |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Scalp nerve block | Procedure | Patient in this group will receive a scalp nerve block using bupivacaine before skull pin fixation to manage to pain. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | From baseline (before skull pin fixation) to 5 minutes after skull pin fixation. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to 5 minutes after skull pin fixation. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Ceyda Ozhan Caparlar, MD | Ankara Etlik City Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Health Sciences Etlik City Hospital | Ankara | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D005283 | Fentanyl |
| D000779 | Anesthetics, Local |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Opioid Anesthetics | Drug | Patient in this group will receive IV opioid for pain management before skull pin fixation |
|
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| Local Anesthetic Injection | Procedure | "Patients in this group will receive a local anesthetic (such as lidocaine) injection at the pin site before skull pin fixation. |
|
|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000588 |
| Amines |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000777 | Anesthetics |
| D002492 | Central Nervous System Depressants |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D018689 | Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |