Endotracheal Intubation During SurgeryNCT06874179
Oropharyngeal Vs Intravenous Lidocaine Effects on Optic Nerve Sheath Diameter After Intubation
A study testing Optic nerve sheath diameter measurement 0, optic nerve sheath diameter measurement 1 and optic nerve sheath diameter measurement 2 in people with Endotracheal Intubation During Surgery and Optic Nerve Sheath Diameter, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Endotracheal Intubation During Surgery, Optic Nerve Sheath Diameter
- What is being tested?
- Optic nerve sheath diameter measurement 0, optic nerve sheath diameter measurement 1 and optic nerve sheath diameter measurement 2
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Mar 2025to 30 Nov 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Dilan Yazar Doğan, resident contact
Turkey (Türkiye)1 site
Ankara Bilkent City Hospital
Ankara, Turkey, 06800
İsmail Aytaç, Ass. prof, +90 505 634 03 69, aytacismail1972@gmail.com
About this study
Official title: 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.
Read the 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.
- Being tested
- Optic nerve sheath diameter measurement 0, optic nerve sheath diameter measurement 1, optic nerve sheath diameter measurement 2, optic nerve sheath diameter measurement 3, Pre-intubation oropharyngeal topical %10 lidocaine
- Keywords
- endotracheal intubation, optic nerve sheath diameter, lidocaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optic nerve sheath diameter measurement 0Diagnostic test
optic nerve sheath diameter (ONSD) measured via ultrasonography before intubation
optic nerve sheath diameter measurement 1Diagnostic test
optic nerve sheath diameter measurement 1 via ultrasonography after intubation 1st minute
optic nerve sheath diameter measurement 2Diagnostic test
optic nerve sheath diameter measurement via ultrasonography after intubation 5th minute
optic nerve sheath diameter measurement 3Diagnostic test
optic nerve sheath diameter measurement via ultrasonography after intubation 10th minute
Pre-intubation oropharyngeal topical %10 lidocaineProcedure or surgery
Pre-intubation oropharyngeal topical %10 lidocaine
Pre-intubation intravenous %2 lidocaineProcedure or surgery
Pre-intubation intravenous %2 lidocaine
| Study group | Role | What they receive |
|---|---|---|
| Group A: Pre-intubation oropharyngeal topical %10 lidocaine | Experimental | Participants will receive 10% lidocaine spray topically to the oropharynx before intubation. Receives: Diagnostic Test: Optic nerve sheath diameter measurement 0; Diagnostic Test: optic nerve sheath diameter measurement 1; Diagnostic Test: optic nerve sheath diameter measurement 2; Diagnostic Test: optic nerve sheath diameter measurement 3; Procedure: Pre-intubation oropharyngeal topical %10 lidocaine |
| Group B: Pre-intubation intravenous %2 lidocaine | Experimental | Participants will receive 2% lidocaine intravenously before intubation. Receives: Diagnostic Test: Optic nerve sheath diameter measurement 0; Diagnostic Test: optic nerve sheath diameter measurement 1; Diagnostic Test: optic nerve sheath diameter measurement 2; Diagnostic Test: optic nerve sheath diameter measurement 3; Procedure: Pre-intubation intravenous %2 lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optic nerve sheath diameter 0
optic nerve sheath diameter (ONSD) measured via ultrasonography before intubation
Measured: Before intubation
Optic nerve sheath diameter 1
optic nerve sheath diameter (ONSD) measured via ultrasonography 1 minute after intubation
Measured: 1 minute after intubation
Optic nerve sheath diameter 2
Optic nerve sheath diameter (ONSD) measured via ultrasonography 5 minutes after intubation
Measured: 5 minutes after intubation
0ptic nerve sheath diameter 3
0ptic nerve sheath diameter (ONSD) measured via ultrasonography 10th minutes after intubation
Measured: 10th minutes after intubation
Secondary outcomes (1)
Postoperative sore throat
Postoperative sore throat is evaluated with Visual Analog scale
Measured: 1 hour after recovery room admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2025
- Study start20 Mar 2025 (estimated)
- Primary completion30 Nov 2025 (estimated)
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endotracheal Intubation During SurgeryStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ismail aytaç, Ankara City Hospital Bilkent
- Investigators
- İsmail Aytaç, Ass. Prof, Principal investigator, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06874179
- Sponsor's protocol ID
- TABED 1-24-831
- Status last verified
- Jan 2025
- First submitted
- 14 Jan 2025
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Oropharyngeal-topical and Intravenous Lidocaine on the Optic Nerve Sheath Diameter Changes After Endotracheal Intubation: a Randomized Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT06874179
- Acronym / sponsor ID
- TABED 1-24-831
- Keywords
- endotracheal intubation, optic nerve sheath diameter, lidocaine
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 20 Mar 2025 (estimated)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 13 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: Pre-intubation oropharyngeal topical %10 lidocaine | Experimental | Diagnostic Test: Optic nerve sheath diameter measurement 0, Diagnostic Test: optic nerve sheath diameter measurement 1, Diagnostic Test: optic nerve sheath diameter measurement 2, Diagnostic Test: optic nerve sheath diameter measurement 3, Procedure: Pre-intubation oropharyngeal topical %10 lidocaineParticipants will receive 10% lidocaine spray topically to the oropharynx before intubation. |
| Group B: Pre-intubation intravenous %2 lidocaine | Experimental | Diagnostic Test: Optic nerve sheath diameter measurement 0, Diagnostic Test: optic nerve sheath diameter measurement 1, Diagnostic Test: optic nerve sheath diameter measurement 2, Diagnostic Test: optic nerve sheath diameter measurement 3, Procedure: Pre-intubation intravenous %2 lidocaineParticipants will receive 2% lidocaine intravenously before intubation. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ASA class I or II
- Age 18-65 years
- BMI 18-30
- No history or expected difficult intubation
- No glaucoma or ocular pathology
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Optic nerve sheath diameter measurement 0optic nerve sheath diameter (ONSD) measured via ultrasonography before intubation | Diagnostic test | Group A: Pre-intubation oropharyngeal topical %10 lidocaine, Group B: Pre-intubation intravenous %2 lidocaine |
| optic nerve sheath diameter measurement 1optic nerve sheath diameter measurement 1 via ultrasonography after intubation 1st minute | Diagnostic test | Group A: Pre-intubation oropharyngeal topical %10 lidocaine, Group B: Pre-intubation intravenous %2 lidocaine |
| optic nerve sheath diameter measurement 2optic nerve sheath diameter measurement via ultrasonography after intubation 5th minute | Diagnostic test | Group A: Pre-intubation oropharyngeal topical %10 lidocaine, Group B: Pre-intubation intravenous %2 lidocaine |
| optic nerve sheath diameter measurement 3optic nerve sheath diameter measurement via ultrasonography after intubation 10th minute | Diagnostic test | Group A: Pre-intubation oropharyngeal topical %10 lidocaine, Group B: Pre-intubation intravenous %2 lidocaine |
| Pre-intubation oropharyngeal topical %10 lidocainePre-intubation oropharyngeal topical %10 lidocaine | Procedure or surgery | Group A: Pre-intubation oropharyngeal topical %10 lidocaine |
| Pre-intubation intravenous %2 lidocainePre-intubation intravenous %2 lidocaine | Procedure or surgery | Group B: Pre-intubation intravenous %2 lidocaine |
Primary outcome
Optic nerve sheath diameter 0
Time frame: Before intubation
optic nerve sheath diameter (ONSD) measured via ultrasonography 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
Optic nerve sheath diameter 2
Time frame: 5 minutes after intubation
Optic nerve sheath diameter (ONSD) measured via ultrasonography 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
1 secondary outcome
Postoperative sore throat
Time frame: 1 hour after recovery room admission
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
- Individual participant dataSharing planned: Undecided. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dilan Yazar Doğan, resident contact
İsmail Aytaç, Ass. Prof principal investigator
Ankara City Hospital Bilkent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optic nerve sheath diameter measurement 0, optic nerve sheath diameter measurement 1 and optic nerve sheath diameter measurement 2 in people with Endotracheal Intubation During Surgery and Optic Nerve Sheath Diameter, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact İsmail Aytaç, Ass. prof (+90 505 634 03 69, aytacismail1972@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Optic nerve sheath diameter 0 (time frame: Before intubation). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2025.