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

March 8, 2025 updated by: ismail aytaç, Ankara City Hospital Bilkent

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

190

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey
      • Ankara, Turkey, 06800
        • Ankara Bilkent City Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A: Pre-intubation oropharyngeal topical %10 lidocaine
Participants will receive 10% lidocaine spray topically to the oropharynx before intubation.
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
Experimental: Group B: Pre-intubation intravenous %2 lidocaine
Participants will receive 2% lidocaine intravenously before intubation.
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 intravenous %2 lidocaine
Pre-intubation intravenous %2 lidocaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Optic nerve sheath diameter 0
Time Frame: Before intubation
optic nerve sheath diameter (ONSD) measured via ultrasonography before intubation
Before intubation
Optic nerve sheath diameter 1
Time Frame: 1 minute after intubation
optic nerve sheath diameter (ONSD) measured via ultrasonography 1 minute after intubation
1 minute after intubation
Optic nerve sheath diameter 2
Time Frame: 5 minutes after intubation
Optic nerve sheath diameter (ONSD) measured via ultrasonography 5 minutes after intubation
5 minutes after intubation
0ptic nerve sheath diameter 3
Time Frame: 10th minutes after intubation
0ptic nerve sheath diameter (ONSD) measured via ultrasonography 10th minutes after intubation
10th minutes after intubation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative sore throat
Time Frame: 1 hour after recovery room admission
Postoperative sore throat is evaluated with Visual Analog scale
1 hour after recovery room admission

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ankara City Hospital Bilkent

Investigators

  • Principal Investigator: İsmail Aytaç, Ass. Prof, Ankara City Hospital Bilkent

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 20, 2025

Primary Completion (Estimated)

November 30, 2025

Study Completion (Estimated)

November 30, 2025

Study Registration Dates

First Submitted

January 14, 2025

First Submitted That Met QC Criteria

March 8, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 8, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TABED 1-24-831

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The individual participant data (IPD) will be made available upon request to scientific committees or researchers for further analysis, subject to ethical and privacy considerations.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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