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NCT Number: NCT06874179

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

  • 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

Treatment and study plan

Optic nerve sheath diameter measurement 0

Diagnostic Test

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

optic nerve sheath diameter measurement 1

Diagnostic Test

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

optic nerve sheath diameter measurement 2

Diagnostic Test

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

optic nerve sheath diameter measurement 3

Diagnostic Test

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

Pre-intubation oropharyngeal topical %10 lidocaine

Procedure

Pre-intubation oropharyngeal topical %10 lidocaine

Pre-intubation intravenous %2 lidocaine

Procedure

Pre-intubation intravenous %2 lidocaine

Primary outcomes

  1. Optic nerve sheath diameter 0

    Time frame: Before intubation

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

  2. Optic nerve sheath diameter 1

    Time frame: 1 minute after intubation

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

  3. Optic nerve sheath diameter 2

    Time frame: 5 minutes after intubation

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

  4. 0ptic nerve sheath diameter 3

    Time frame: 10th minutes after intubation

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

Secondary outcomes

  1. Postoperative sore throat

    Time frame: 1 hour after recovery room admission

    Postoperative sore throat is evaluated with Visual Analog scale

Study contacts

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

Dilan Yazar Doğan, resident

CONTACT

[email protected]

İsmail Aytaç, Ass. prof

CONTACT

[email protected]

+90 505 634 03 69

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Registry information

Official study title

Effects of Oropharyngeal-topical and Intravenous Lidocaine on the Optic Nerve Sheath Diameter Changes After Endotracheal Intubation: a Randomized Controlled Clinical Study

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 13, 2025
Registry last updated
Mar 13, 2025

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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