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

Not Applicable

Not yet recruiting

• Conditions: Endotracheal Intubation During Surgery; Optic Nerve Sheath Diameter

• Registration Number: NCT06874179
• Lead Sponsor: Ankara City Hospital Bilkent

Brief 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.

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.

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-14
• Study First Submitted QC: 2025-03-08
• Last Update Submitted: 2025-03-08
• Study First Posted: 2025-03-13
• Last Update Posted: 2025-03-13
• Study Start: 2025-03-20
• Primary Completion: 2025-11-30
• Study Completion: 2025-11-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 190

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Optic nerve sheath diameter 0	Before intubation	optic nerve sheath diameter (ONSD) measured via ultrasonography before intubation
Optic nerve sheath diameter 1	1 minute after intubation	optic nerve sheath diameter (ONSD) measured via ultrasonography 1 minute after intubation
Optic nerve sheath diameter 2	5 minutes after intubation	Optic nerve sheath diameter (ONSD) measured via ultrasonography 5 minutes after intubation
0ptic nerve sheath diameter 3	10th minutes after intubation	0ptic nerve sheath diameter (ONSD) measured via ultrasonography 10th minutes after intubation

Secondary Outcome Measures

Name	Time	Method
Postoperative sore throat	1 hour after recovery room admission	Postoperative sore throat is evaluated with Visual Analog scale

Trial Locations

Locations (1)

Ankara Bilkent City Hospital; 🇹🇷 Ankara, Turkey