頭蓋筋における頭蓋骨のピン固定による痛みに対する反応の評価
BIS-DSA（bıspectralインデックス密度スペクトルアレイ）および血行動態による頭蓋筋の頭蓋骨固定による痛みに対する反応の評価
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.
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Ankara、トルコ（Türkiye）
- University of Health Sciences Etlik City Hospital
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
"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.
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 観測モデル：COHORT
- 時間の展望：PROSPECTIVE
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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Group 1: Scalp group
"This group consists of patients who receive a scalp nerve block for pain management during skull pin fixation." |
Patient in this group will receive a scalp nerve block using bupivacaine before skull pin fixation to manage to pain.
他の名前：
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Group 2: Opioid Group
"This group consists of patients who receive intravenous opioids for pain management during skull pin fixation." |
Patient in this group will receive IV opioid for pain management before skull pin fixation
他の名前：
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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." |
"Patients in this group will receive a local anesthetic (such as lidocaine) injection at the pin site before skull pin fixation.
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Changes in BIS-DSA spectral analysis before and after skull pin fixation
時間枠：From baseline (before skull pin fixation) to 5 minutes after skull pin fixation.
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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.
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Changes in Mean Arterial Pressure (MAP) before and after skull pin fixation
時間枠：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. |
Baseline to 5 minutes after skull pin fixation.
|
協力者と研究者
捜査官
- 主任研究者：Ceyda Ozhan Caparlar, MD、Ankara Etlik City Hospital
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- AESH-BADEK-2024-1016
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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