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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06874179
Enrollment
190
Registered
2025-03-13
Start date
2025-03-20
Completion date
2025-11-30
Last updated
2025-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endotracheal Intubation During Surgery, Optic Nerve Sheath Diameter

Keywords

endotracheal intubation, optic nerve sheath diameter, lidocaine

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.

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

Sponsors

Ankara City Hospital Bilkent
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Masking description

Double-blinded (Participants and Outcome Assessors)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
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

* 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

Design outcomes

Primary

MeasureTime frameDescription
Optic nerve sheath diameter 0Before intubationoptic nerve sheath diameter (ONSD) measured via ultrasonography before intubation
Optic nerve sheath diameter 11 minute after intubationoptic nerve sheath diameter (ONSD) measured via ultrasonography 1 minute after intubation
Optic nerve sheath diameter 25 minutes after intubationOptic nerve sheath diameter (ONSD) measured via ultrasonography 5 minutes after intubation
0ptic nerve sheath diameter 310th minutes after intubation0ptic nerve sheath diameter (ONSD) measured via ultrasonography 10th minutes after intubation

Secondary

MeasureTime frameDescription
Postoperative sore throat1 hour after recovery room admissionPostoperative sore throat is evaluated with Visual Analog scale

Countries

Turkey (Türkiye)

Contacts

Primary Contactİsmail Aytaç, Ass. prof
aytacismail1972@gmail.com+90 505 634 03 69
Backup ContactDilan Yazar Doğan, resident
yazardilan@gmail.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026