Avaliação da resposta à dor da fixação do pino do crânio em craniotomias
Avaliação da resposta à dor da fixação do pino do crânio em craniotomias com Bis-DSA (matriz espectral de densidade de índice Bıspectral) e hemodinâmica
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.
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
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Ankara, Turquia (Türkiye)
- University of Health Sciences Etlik City Hospital
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
"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.
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Modelos de observação: COHORT
- Perspectivas de Tempo: PROSPECTIVE
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
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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.
Outros nomes:
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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
Outros nomes:
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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.
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Changes in BIS-DSA spectral analysis before and after skull pin fixation
Prazo: 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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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Changes in Mean Arterial Pressure (MAP) before and after skull pin fixation
Prazo: 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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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Ceyda Ozhan Caparlar, MD, Ankara Etlik City Hospital
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Manifestações Neurológicas
- Doenças do Sistema Nervoso
- Manifestações Neurocomportamentais
- Distúrbios Perceptivos
- Condições Patológicas, Sinais e Sintomas
- Sinais e sintomas
- Agnosia
- Efeitos fisiológicos das drogas
- Agentes do Sistema Nervoso Periférico
- Anestésicos
- Depressores do Sistema Nervoso Central
- Agentes do Sistema Sensorial
- Produtos químicos orgânicos
- Compostos heterocíclicos, 1 anel
- Compostos heterocíclicos
- Ações farmacológicas
- Ações e usos químicos
- Usos terapêuticos
- Anilides
- Amidas
- Compostos de anilina
- Aminas
- Piperidinas
- Agentes do sistema nervoso central
- Bupivacaína
- Fentanil
- Anestésicos Locais
Outros números de identificação do estudo
- AESH-BADEK-2024-1016
Plano para dados de participantes individuais (IPD)
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