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.
Panoramica dello studio
Stato
Intervento / Trattamento
Descrizione dettagliata
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 di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Arsen Güngör Ay, MD
- Numero di telefono: +905534948426
- Email: arsen.gungor@hotmail.com
Luoghi di studio
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Istanbul
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Istanbul, Istanbul, Turchia (Türkiye), 34752
- Fatih Sultan Mehmet Training and Research Hospital
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Contatto:
- Arsen Güngör Ay, MD
- Numero di telefono: 0905534948426
- Email: arsen.gungor@hotmail.com
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: 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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Comparatore attivo: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change in ONSD/ETD Ratio at 5 Minutes After Endotracheal Intubation
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change in ONSD/ETD Ratio at 10 Minutes After Endotracheal Intubation
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- ONSD/ETD
Piano per i dati dei singoli partecipanti (IPD)
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Descrizione del piano IPD
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