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.
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Arsen Güngör Ay, MD
- Telefonnummer: +905534948426
- E-post: arsen.gungor@hotmail.com
Studiesteder
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Istanbul
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Istanbul, Istanbul, Tyrkia (Türkiye), 34752
- Fatih Sultan Mehmet Training and Research Hospital
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Ta kontakt med:
- Arsen Güngör Ay, MD
- Telefonnummer: 0905534948426
- E-post: arsen.gungor@hotmail.com
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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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Aktiv komparator: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change in ONSD/ETD Ratio at 5 Minutes After Endotracheal Intubation
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change in ONSD/ETD Ratio at 10 Minutes After Endotracheal Intubation
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- ONSD/ETD
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
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