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Not yet recruiting NCT06874179

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

No phase Interventional Endotracheal Intubation During Surgery Optic Nerve Sheath Diameter

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Optic nerve sheath diameter measurement 0, optic nerve sheath diameter measurement 1, optic nerve sheath diameter measurement 2, optic nerve sheath diameter measurement 3.
Who it may be relevant to
Registry conditions: Endotracheal Intubation During Surgery, Optic Nerve Sheath Diameter. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

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.

Interventions

  • Diagnostic test Optic nerve sheath diameter measurement 0
    optic nerve sheath diameter (ONSD) measured via ultrasonography before intubation
  • Diagnostic test optic nerve sheath diameter measurement 1
    optic nerve sheath diameter measurement 1 via ultrasonography after intubation 1st minute
  • Diagnostic test optic nerve sheath diameter measurement 2
    optic nerve sheath diameter measurement via ultrasonography after intubation 5th minute
  • Diagnostic test optic nerve sheath diameter measurement 3
    optic nerve sheath diameter measurement via ultrasonography after intubation 10th minute
  • Procedure Pre-intubation oropharyngeal topical %10 lidocaine
    Pre-intubation oropharyngeal topical %10 lidocaine
  • Procedure Pre-intubation intravenous %2 lidocaine
    Pre-intubation intravenous %2 lidocaine

Primary outcome measures

  • Optic nerve sheath diameter 0 [Time frame: Before intubation]
  • Optic nerve sheath diameter 1 [Time frame: 1 minute after intubation]
  • Optic nerve sheath diameter 2 [Time frame: 5 minutes after intubation]
  • 0ptic nerve sheath diameter 3 [Time frame: 10th minutes after intubation]
Secondary outcome measures (1)
  • Postoperative sore throat [Time frame: 1 hour after recovery room admission]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Diagnostic

Study locations

Turkey (Türkiye) · 1 center
  • Ankara Bilkent City Hospital — Ankara

Identifiers

NCT: NCT06874179 · TABED 1-24-831

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗