NCT07660861

Brief Summary

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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
11mo left

Started Jun 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress11%
Jun 2026Jul 2027

First Submitted

Initial submission to the registry

June 16, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 22, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

June 22, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

June 22, 2026

Status Verified

June 1, 2026

Enrollment Period

11 months

First QC Date

June 16, 2026

Last Update Submit

June 16, 2026

Conditions

Keywords

Optic Nerve Sheath DiameterIntracranial PressureRemifentanilEsmololCoil Embolization

Outcome Measures

Primary Outcomes (1)

  • Change in ONSD/ETD Ratio at 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

Secondary Outcomes (4)

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

    10 minutes after endotracheal intubation

  • Change in Mean Arterial Pressure

    Baseline, 5 minutes, and 10 minutes after intubation

  • Change in Heart Rate

    Baseline, 5 minutes, and 10 minutes after intubation

  • Vasopressor Requirement

    From intubation until 10 minutes after intubation

Study Arms (2)

remifentanil group

EXPERIMENTAL

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.

Drug: Remifentanil

Esmolol Group

ACTIVE COMPARATOR

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.

Drug: Esmolol

Interventions

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

remifentanil group

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

Esmolol Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fatih Sultan Mehmet Training and Research Hospital

Istanbul, Istanbul, 34752, Turkey (Türkiye)

Location

Related Publications (3)

  • 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

    BACKGROUND
  • 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.

    PMID: 38610872BACKGROUND
  • 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.

MeSH Terms

Interventions

Remifentanilesmolol

Intervention Hierarchy (Ancestors)

PropionatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Central Study Contacts

Arsen Güngör Ay, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants undergoing elective cerebral aneurysm coil embolization under general anesthesia will be randomly assigned in a 1:1 ratio to receive either remifentanil or esmolol before endotracheal intubation. Outcomes will be compared between the two parallel groups.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2026

First Posted

June 22, 2026

Study Start

June 22, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

July 1, 2027

Last Updated

June 22, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

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

Locations