NCT06874179

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
190

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 14, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 13, 2025

Completed
7 days until next milestone

Study Start

First participant enrolled

March 20, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2025

Completed
Last Updated

March 13, 2025

Status Verified

January 1, 2025

Enrollment Period

9 months

First QC Date

January 14, 2025

Last Update Submit

March 8, 2025

Conditions

Endotracheal Intubation During SurgeryOptic Nerve Sheath Diameter

Keywords

endotracheal intubationoptic nerve sheath diameterlidocaine

Outcome Measures

Primary Outcomes (4)

  • Optic nerve sheath diameter 0

    optic nerve sheath diameter (ONSD) measured via ultrasonography before intubation

    Before intubation

  • Optic nerve sheath diameter 1

    optic nerve sheath diameter (ONSD) measured via ultrasonography 1 minute after intubation

    1 minute after intubation

  • Optic nerve sheath diameter 2

    Optic nerve sheath diameter (ONSD) measured via ultrasonography 5 minutes after intubation

    5 minutes after intubation

  • 0ptic nerve sheath diameter 3

    0ptic nerve sheath diameter (ONSD) measured via ultrasonography 10th minutes after intubation

    10th minutes after intubation

Secondary Outcomes (1)

  • Postoperative sore throat

    1 hour after recovery room admission

Study Arms (2)

Group A: Pre-intubation oropharyngeal topical %10 lidocaine

EXPERIMENTAL

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

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

Group B: Pre-intubation intravenous %2 lidocaine

EXPERIMENTAL

Participants will receive 2% lidocaine intravenously before intubation.

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

Interventions

Optic nerve sheath diameter measurement 0DIAGNOSTIC_TEST

optic nerve sheath diameter (ONSD) measured via ultrasonography before intubation

Group A: Pre-intubation oropharyngeal topical %10 lidocaineGroup B: Pre-intubation intravenous %2 lidocaine
optic nerve sheath diameter measurement 1DIAGNOSTIC_TEST

optic nerve sheath diameter measurement 1 via ultrasonography after intubation 1st minute

Group A: Pre-intubation oropharyngeal topical %10 lidocaineGroup B: Pre-intubation intravenous %2 lidocaine
optic nerve sheath diameter measurement 2DIAGNOSTIC_TEST

optic nerve sheath diameter measurement via ultrasonography after intubation 5th minute

Group A: Pre-intubation oropharyngeal topical %10 lidocaineGroup B: Pre-intubation intravenous %2 lidocaine
optic nerve sheath diameter measurement 3DIAGNOSTIC_TEST

optic nerve sheath diameter measurement via ultrasonography after intubation 10th minute

Group A: Pre-intubation oropharyngeal topical %10 lidocaineGroup B: Pre-intubation intravenous %2 lidocaine
Pre-intubation oropharyngeal topical %10 lidocainePROCEDURE

Pre-intubation oropharyngeal topical %10 lidocaine

Group A: Pre-intubation oropharyngeal topical %10 lidocaine
Pre-intubation intravenous %2 lidocainePROCEDURE

Pre-intubation intravenous %2 lidocaine

Group B: Pre-intubation intravenous %2 lidocaine

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, Turkey, 06800, Turkey (Türkiye)

Location

Study Officials

  • İsmail Aytaç, Ass. Prof

    Ankara City Hospital Bilkent

    PRINCIPAL INVESTIGATOR

Central Study Contacts

İsmail Aytaç, Ass. prof

CONTACT

+90 505 634 03 69aytacismail1972@gmail.com

Dilan Yazar Doğan, resident

CONTACT

yazardilan@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Double-blinded (Participants and Outcome Assessors)
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ass.Prof.Dr. İsmail Aytaç

Study Record Dates

First Submitted

January 14, 2025

First Posted

March 13, 2025

Study Start

March 20, 2025

Primary Completion

November 30, 2025

Study Completion

November 30, 2025

Last Updated

March 13, 2025

Record last verified: 2025-01

Locations

TU(1)