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NCT Number: NCT07660861

Remifentanil vs Esmolol During Intubation for Cerebral Aneurysm Coil Embolization

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fatih Sultan Mehmet Training and Research Hospital

Istanbul, 34752, Turkey (Türkiye)

Location contact

Arsen Güngör Ay, MD

CONTACT

[email protected]

0905534948426

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Remifentanil

Drug

Remifentanil 0.5-1 µg/kg IV administered over 90 seconds before endotracheal intubation.

esmolol

Drug

Esmolol 0.5-1 mg/kg IV administered over 90 seconds before endotracheal intubation.

Primary outcomes

  1. Change in ONSD/ETD Ratio at 5 Minutes After Endotracheal Intubation

    Time frame: 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).

Secondary outcomes

  1. Change in ONSD/ETD Ratio at 10 Minutes After Endotracheal Intubation

    Time frame: 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).

  2. Change in Mean Arterial Pressure

    Time frame: 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.

  3. Change in Heart Rate

    Time frame: Baseline, 5 minutes, and 10 minutes after intubation

    Changes in heart rate measured before intubation, 5 minutes after intubation, and 10 minutes after intubation.

  4. Vasopressor Requirement

    Time frame: From intubation until 10 minutes after intubation

    Requirement for vasopressor administration during the study period following endotracheal intubation.

Study contacts

Contact information is provided by the study sponsor or research team.

Arsen Güngör Ay, MD

CONTACT

[email protected]

+905534948426

Sponsors and collaborators

Lead sponsor

Fatih Sultan Mehmet Training and Research Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 22, 2026
Registry last updated
Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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