Evaluación de la respuesta al dolor de la fijación del pasador del cráneo en las craneotomías
Evaluación de la respuesta al dolor de la fijación del pasador del cráneo en craniotomías con BIS-DSA (matriz espectral de densidad de índice Bıpectral) y hemodinámica
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.
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
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 estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
-
Ankara, Turquía (Türkiye)
- University of Health Sciences Etlik City Hospital
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
"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.
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: COHORT
- Perspectivas temporales: PROSPECTIVE
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
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.
Otros nombres:
|
|
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
Otros nombres:
|
|
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.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Changes in BIS-DSA spectral analysis before and after skull pin fixation
Periodo de tiempo: 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 |
From baseline (before skull pin fixation) to 5 minutes after skull pin fixation.
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Changes in Mean Arterial Pressure (MAP) before and after skull pin fixation
Periodo de tiempo: 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.
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Ceyda Ozhan Caparlar, MD, Ankara Etlik City Hospital
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Manifestaciones neurológicas
- Enfermedades del Sistema Nervioso
- Manifestaciones neuroconductuales
- Trastornos de la percepción
- Condiciones Patológicas, Signos y Síntomas
- Signos y síntomas
- Agnosia
- Efectos fisiológicos de las drogas
- Agentes del sistema nervioso periférico
- Anestésicos
- Depresores del sistema nervioso central
- Agentes del sistema sensorial
- Químicos orgánicos
- Compuestos heterocíclicos, 1 anillo
- Compuestos heterocíclicos
- Acciones farmacológicas
- Acciones y usos químicos
- Usos terapéuticos
- Aniluros
- Amidas
- Compuestos anilina
- Amina
- Piperidinas
- Agentes del sistema nervioso central
- Bupivacaína
- Fentanilo
- Anestésicos Locales
Otros números de identificación del estudio
- AESH-BADEK-2024-1016
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .