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

Ankara City Hospital

Status: Not yet enrolling

Conditions: Optic Nerve Sheath Diameter; Endotracheal Intubation During Surgery

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06874179

TABED 1-24-831

Details and patient eligibility

About

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.

Full 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.

Enrollment: 190 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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190 participants in 2 patient groups

Group A: Pre-intubation oropharyngeal topical %10 lidocaine

Experimental group

Description:

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

Treatment:

Diagnostic Test: optic nerve sheath diameter measurement 2

Diagnostic Test: optic nerve sheath diameter measurement 3

Procedure: Pre-intubation oropharyngeal topical %10 lidocaine

Diagnostic Test: optic nerve sheath diameter measurement 1

Diagnostic Test: Optic nerve sheath diameter measurement 0

Group B: Pre-intubation intravenous %2 lidocaine

Experimental group

Description:

Participants will receive 2% lidocaine intravenously before intubation.

Treatment:

Diagnostic Test: optic nerve sheath diameter measurement 2

Diagnostic Test: optic nerve sheath diameter measurement 3

Procedure: Pre-intubation intravenous %2 lidocaine

Diagnostic Test: optic nerve sheath diameter measurement 1

Diagnostic Test: Optic nerve sheath diameter measurement 0