두개골 핀 고정으로 인한 통증에 대한 반응 평가 craniotomies
BIS-DSA (Bıspectral Index-Density Spectral Array) 및 혈역학을 사용한 두개골에서 두개골 핀 고정에서 통증에 대한 반응 평가
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.
연구 개요
상태
상세 설명
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.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Ankara, 터키 (Türkiye)
- University of Health Sciences Etlik City Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
"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.
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: COHORT
- 시간 관점: PROSPECTIVE
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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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.
다른 이름들:
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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
다른 이름들:
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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.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Changes in BIS-DSA spectral analysis before and after skull pin fixation
기간: 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.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Changes in Mean Arterial Pressure (MAP) before and after skull pin fixation
기간: Baseline to 5 minutes after skull pin fixation.
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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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공동 작업자 및 조사자
수사관
- 수석 연구원: Ceyda Ozhan Caparlar, MD, Ankara Etlik City Hospital
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- AESH-BADEK-2024-1016
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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