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Remifentanil vs Esmolol During Intubation for Cerebral Aneurysm Coil Embolization

16. juni 2026 opdateret af: Fatih Sultan Mehmet Training and Research Hospital

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

84

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Tyrkiet (Türkiye)
    • Istanbul
      • Istanbul, Istanbul, Tyrkiet (Türkiye), 34752
        • Fatih Sultan Mehmet Training and Research Hospital
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Medicin: Remifentanil
Remifentanil 0.5-1 µg/kg IV administered over 90 seconds before endotracheal intubation.
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.
Medicin: Esmolol
Esmolol 0.5-1 mg/kg IV administered over 90 seconds before endotracheal intubation.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in ONSD/ETD Ratio at 5 Minutes After Endotracheal Intubation
Tidsramme: 5 minutes after endotracheal intubation
Difference between baseline (pre-intubation) and 5-minute post-intubation optic nerve sheath diameter-to-eyeball transverse diameter ratio (ONSD/ETD).
5 minutes after endotracheal intubation

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in ONSD/ETD Ratio at 10 Minutes After Endotracheal Intubation
Tidsramme: 10 minutes after endotracheal intubation
Difference between baseline (pre-intubation) and 10-minute post-intubation optic nerve sheath diameter-to-eyeball transverse diameter ratio (ONSD/ETD).
10 minutes after endotracheal intubation
Change in Mean Arterial Pressure
Tidsramme: Baseline, 5 minutes, and 10 minutes after intubation
Changes in mean arterial pressure measured before intubation, 5 minutes after intubation, and 10 minutes after intubation.
Baseline, 5 minutes, and 10 minutes after intubation
Change in Heart Rate
Tidsramme: Baseline, 5 minutes, and 10 minutes after intubation
Changes in heart rate measured before intubation, 5 minutes after intubation, and 10 minutes after intubation.
Baseline, 5 minutes, and 10 minutes after intubation
Vasopressor Requirement
Tidsramme: From intubation until 10 minutes after intubation
Requirement for vasopressor administration during the study period following endotracheal intubation.
From intubation until 10 minutes after intubation

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Fatih Sultan Mehmet Training and Research Hospital

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

22. juni 2026

Primær færdiggørelse (Anslået)

1. juni 2027

Studieafslutning (Anslået)

1. juli 2027

Datoer for studieregistrering

Først indsendt

16. juni 2026

Først indsendt, der opfyldte QC-kriterier

16. juni 2026

Først opslået (Faktiske)

22. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

22. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

16. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • ONSD/ETD

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

There is no plan to make individual participant data (IPD) publicly available.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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