Remifentanil vs Esmolol During Intubation for Cerebral Aneurysm Coil Embolization
Effects of Remifentanil Versus Esmolol on Optic Nerve Sheath Diameter/Eyeball Transverse Diameter Ratio During Endotracheal Intubation in Patients Undergoing Cerebral Aneurysm Coil Embolization: A Randomized Controlled Trial
Endotracheal intubation may cause significant increases in blood pressure, heart rate, and intracranial pressure, particularly in patients undergoing cerebral aneurysm coil embolization. Remifentanil and esmolol are commonly used agents to attenuate these responses during anesthesia induction.
This randomized controlled trial aims to compare the effects of remifentanil and esmolol administered before endotracheal intubation on optic nerve sheath diameter/eyeball transverse diameter ratio (ONSD/ETD), a noninvasive surrogate marker of intracranial pressure, as well as hemodynamic responses in patients undergoing elective cerebral aneurysm coil embolization.
The findings may help identify the most effective strategy for minimizing intubation-related intracranial pressure changes and hemodynamic fluctuations in neurointerventional anesthesia practice.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Endotracheal intubation is one of the most stimulating periods during induction of general anesthesia and is associated with transient increases in blood pressure, heart rate, and intracranial pressure. These responses may be particularly important in patients undergoing cerebral aneurysm coil embolization, where excessive hemodynamic fluctuations and increases in intracranial pressure may adversely affect procedural safety.
Optic nerve sheath diameter (ONSD) measured by ultrasonography has emerged as a noninvasive marker of intracranial pressure. The optic nerve sheath diameter-to-eyeball transverse diameter ratio (ONSD/ETD) has been proposed as a more standardized parameter that may reduce interindividual variability.
Remifentanil and esmolol are widely used agents for attenuation of the hemodynamic response to endotracheal intubation. Although both agents have been shown to reduce sympathetic activation during airway manipulation, their comparative effects on ONSD/ETD ratio and intubation-related intracranial pressure changes in patients undergoing neurointerventional procedures remain unclear.
The aim of this prospective randomized controlled trial is to compare the effects of remifentanil and esmolol administered before endotracheal intubation on ONSD/ETD ratio and hemodynamic parameters in adult patients undergoing elective cerebral aneurysm coil embolization. Participants will be randomized in a 1:1 ratio to receive either remifentanil (0.5-1 µg/kg IV) or esmolol (0.5-1 mg/kg IV) administered over 90 seconds before intubation.
ONSD/ETD measurements and hemodynamic parameters will be recorded before intubation (T0), 5 minutes after intubation (T1), and 10 minutes after intubation (T2). The primary outcome will be the change in ONSD/ETD ratio at 5 minutes after intubation. Secondary outcomes include changes in ONSD/ETD ratio at 10 minutes, mean arterial pressure, heart rate, and vasopressor requirements.
The results of this study may provide evidence regarding the optimal pharmacological strategy for attenuating intubation-related intracranial pressure changes and hemodynamic responses in patients undergoing cerebral aneurysm coil embolization.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Arsen Güngör Ay, MD
- Número de teléfono: +905534948426
- Correo electrónico: arsen.gungor@hotmail.com
Ubicaciones de estudio
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Istanbul
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Istanbul, Istanbul, Turquía (Türkiye), 34752
- Fatih Sultan Mehmet Training and Research Hospital
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Contacto:
- Arsen Güngör Ay, MD
- Número de teléfono: 0905534948426
- Correo electrónico: arsen.gungor@hotmail.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Age ≥18 years
- American Society of Anesthesiologists (ASA) physical status I-III
- Scheduled for elective cerebral aneurysm coil embolization under general anesthesia
- Planned endotracheal intubation
- Ability to provide written informed consent
Exclusion Criteria:
- Emergency procedures
- Hemodynamic instability before induction of anesthesia
- Severe cardiac conduction abnormalities or clinically significant arrhythmias
- Contraindication or allergy to remifentanil or esmolol
- Chronic opioid use or opioid dependence
- Known orbital disease, ocular trauma, or conditions interfering with optic nerve sheath diameter measurements
- Anticipated difficult airway
- Pregnancy
- Refusal to participate in the study
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: remifentanil group
Participants will receive remifentanil 0.5-1 µg/kg intravenously over 90 seconds before endotracheal intubation during induction of general anesthesia for elective cerebral aneurysm coil embolization.
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Remifentanil 0.5-1 µg/kg IV administered over 90 seconds before endotracheal intubation.
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Comparador activo: Esmolol Group
Participants will receive esmolol 0.5-1 mg/kg intravenously over 90 seconds before endotracheal intubation during induction of general anesthesia for elective cerebral aneurysm coil embolization.
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Esmolol 0.5-1 mg/kg IV administered over 90 seconds before endotracheal intubation.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in ONSD/ETD Ratio at 5 Minutes After Endotracheal Intubation
Periodo de tiempo: 5 minutes after endotracheal intubation
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Difference between baseline (pre-intubation) and 5-minute post-intubation optic nerve sheath diameter-to-eyeball transverse diameter ratio (ONSD/ETD).
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5 minutes after endotracheal intubation
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in ONSD/ETD Ratio at 10 Minutes After Endotracheal Intubation
Periodo de tiempo: 10 minutes after endotracheal intubation
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Difference between baseline (pre-intubation) and 10-minute post-intubation optic nerve sheath diameter-to-eyeball transverse diameter ratio (ONSD/ETD).
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10 minutes after endotracheal intubation
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Change in Mean Arterial Pressure
Periodo de tiempo: Baseline, 5 minutes, and 10 minutes after intubation
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Changes in mean arterial pressure measured before intubation, 5 minutes after intubation, and 10 minutes after intubation.
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Baseline, 5 minutes, and 10 minutes after intubation
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Change in Heart Rate
Periodo de tiempo: Baseline, 5 minutes, and 10 minutes after intubation
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Changes in heart rate measured before intubation, 5 minutes after intubation, and 10 minutes after intubation.
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Baseline, 5 minutes, and 10 minutes after intubation
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Vasopressor Requirement
Periodo de tiempo: From intubation until 10 minutes after intubation
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Requirement for vasopressor administration during the study period following endotracheal intubation.
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From intubation until 10 minutes after intubation
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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Publicaciones Generales
- Öner, Ö., & Yıldız, E. (2020). Comparison of The Effects of Remifentanil, Fentanyl, Esmolol, Lidocaine, and Amiodarone in Preventing Hemodynamic Response to Intubation. Kahramanmaraş Sütçü İmam Üniversitesi Tıp Fakültesi Dergisi, 15(3), 22-29. https://doi.org/10.17517/ksutfd.673702
- Kim KH, Kang HK, Koo HW. Prediction of Intracranial Pressure in Patients with an Aneurysmal Subarachnoid Hemorrhage Using Optic Nerve Sheath Diameter via Explainable Predictive Modeling. J Clin Med. 2024 Apr 4;13(7):2107. doi: 10.3390/jcm13072107.
- Fu H, Hu J, Zhang X, Xie K, Hu L. Effect of different anesthesia strategies on intracranial pressure during extubation after intracranial aneurysm embolization: a randomized controlled trial. Sci Rep. 2026 Apr 18. doi: 10.1038/s41598-026-49045-6. Online ahead of print.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
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
Otros números de identificación del estudio
- ONSD/ETD
Plan de datos de participantes individuales (IPD)
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Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
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