CClinicalTrials.gg
Not yet recruitingNCT06874179Updated Mar 13, 2025

Oropharyngeal Vs Intravenous Lidocaine Effects on Optic Nerve Sheath Diameter After Intubation

An interventional study of Optic nerve sheath diameter measurement 0 and optic nerve sheath diameter measurement 1 in Endotracheal Intubation During Surgery and Optic Nerve Sheath Diameter, sponsored by Ankara City Hospital Bilkent. Not yet recruiting at 1 site in Turkey. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-03-13.

Sponsored by Ankara City Hospital Bilkent · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Primary completion was expected by Nov 2025, 10 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
190
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
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Study summary

This study aims to evaluate the effects of pre-intubation oropharyngeal topical lidocaine on optic nerve sheath diameter (ONSD) post-endotracheal intubation. The study will measure the ONSD using ultrasonography before intubation, and at 1, 5, and 10 minutes post-intubation. The results will be compared between patients receiving %10 lidocaine topically and %2 intravenous lidocaine.

Read the detailed description

Increased intracranial pressure (ICP) is a critical condition that requires early and accurate assessment. Traditional invasive ICP monitoring techniques, such as lumbar puncture and intracranial pressure monitoring devices, carry significant risks. Optic nerve sheath diameter (ONSD) measurement via ultrasonography is a non-invasive method that reflects increased ICP.

Patients will be divided into two groups: Group A will receive %10 topical oropharyngeal lidocaine, and Group B will receive %2 intravenous lidocaine. The primary aim of the study is to evaluate the impact of lidocaine on ONSD at 1, 5, and 10 minutes post-intubation and to compare the effects on the two groups.

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Conditions studied

  • Endotracheal Intubation During Surgery
  • Optic Nerve Sheath Diameter

Keywords

  • endotracheal intubation
  • optic nerve sheath diameter
  • lidocaine
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In context

Lead sponsor

Ankara City Hospital Bilkent is the lead sponsor of 424 studies on the registry; 105 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • ASA class I or II
  • Age 18-65 years
  • BMI 18-30
  • No history or expected difficult intubation
  • No glaucoma or ocular pathology
  • No intracranial pressure increase

Exclusion criteria

Exclusion Criteria:

  • ASA class III and above
  • Obesity (BMI > 30)
  • Difficult intubation history or risk
  • Glaucoma or other ophthalmic pathology
  • History of intracranial pressure increase or prior ophthalmic/intracranial surgery
  • Preoperative sedation
  • Active malignancy or ongoing radiotherapy/chemotherapy
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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
190 participants (estimated)

Study arms

  • Experimental
    Group A: Pre-intubation oropharyngeal topical %10 lidocaine

    Participants will receive 10% lidocaine spray topically to the oropharynx before intubation.

    Diagnostic Test: Optic nerve sheath diameter measurement 0 · Diagnostic Test: optic nerve sheath diameter measurement 1 · Diagnostic Test: optic nerve sheath diameter measurement 2 · Diagnostic Test: optic nerve sheath diameter measurement 3 · Procedure: Pre-intubation oropharyngeal topical %10 lidocaine

  • Experimental
    Group B: Pre-intubation intravenous %2 lidocaine

    Participants will receive 2% lidocaine intravenously before intubation.

    Diagnostic Test: Optic nerve sheath diameter measurement 0 · Diagnostic Test: optic nerve sheath diameter measurement 1 · Diagnostic Test: optic nerve sheath diameter measurement 2 · Diagnostic Test: optic nerve sheath diameter measurement 3 · Procedure: Pre-intubation intravenous %2 lidocaine

Interventions

  • Diagnostic testOptic nerve sheath diameter measurement 0

    optic nerve sheath diameter (ONSD) measured via ultrasonography before intubation

  • Diagnostic testoptic nerve sheath diameter measurement 1

    optic nerve sheath diameter measurement 1 via ultrasonography after intubation 1st minute

  • Diagnostic testoptic nerve sheath diameter measurement 2

    optic nerve sheath diameter measurement via ultrasonography after intubation 5th minute

  • Diagnostic testoptic nerve sheath diameter measurement 3

    optic nerve sheath diameter measurement via ultrasonography after intubation 10th minute

  • ProcedurePre-intubation oropharyngeal topical %10 lidocaine

    Pre-intubation oropharyngeal topical %10 lidocaine

  • ProcedurePre-intubation intravenous %2 lidocaine

    Pre-intubation intravenous %2 lidocaine

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What researchers measure

Primary outcomes

  1. Optic nerve sheath diameter 0

    optic nerve sheath diameter (ONSD) measured via ultrasonography before intubation

    Time frame: Before intubation

  2. Optic nerve sheath diameter 1

    optic nerve sheath diameter (ONSD) measured via ultrasonography 1 minute after intubation

    Time frame: 1 minute after intubation

  3. Optic nerve sheath diameter 2

    Optic nerve sheath diameter (ONSD) measured via ultrasonography 5 minutes after intubation

    Time frame: 5 minutes after intubation

  4. 0ptic nerve sheath diameter 3

    0ptic nerve sheath diameter (ONSD) measured via ultrasonography 10th minutes after intubation

    Time frame: 10th minutes after intubation

Secondary outcomes

  1. Postoperative sore throat

    Postoperative sore throat is evaluated with Visual Analog scale

    Time frame: 1 hour after recovery room admission

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Study locations

1 site
  • Ankara Bilkent City Hospital
    Ankara, 06800, Turkey
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References and documents

Individual participant data

Plan to share: Undecided — The individual participant data (IPD) will be made available upon request to scientific committees or researchers for further analysis, subject to ethical and privacy considerations.

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 13, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06874179
Lead sponsor
Ankara City Hospital Bilkent
Responsible party
ismail aytaç (Ass.Prof.Dr. İsmail Aytaç, Ankara City Hospital Bilkent) — Principal investigator
First posted
Mar 13, 2025
Start date
Mar 20, 2025 (estimated)
Primary completion
Nov 30, 2025 (estimated)
Completion
Nov 30, 2025 (estimated)
Last update
Mar 13, 2025

Study contacts

İsmail Aytaç, Ass. prof
Contact
aytacismail1972@gmail.com
+90 505 634 03 69
Dilan Yazar Doğan, resident
Contact
yazardilan@gmail.com
İsmail Aytaç, Ass. Prof
principal investigator · Ankara City Hospital Bilkent

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

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