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

Ankara City Hospital Bilkent1 个研究点分布在 1 个国家目标入组 190 人开始时间: 2025年3月20日最近更新: 2025年3月13日

适应症

干预措施

试验速览

阶段: 不适用
状态: 尚未招募
发起方: Ankara City Hospital Bilkent
入组人数: 190
试验地点: 1
主要终点: Optic nerve sheath diameter 0

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Diagnostic
盲法: Triple (Participant, Investigator, Outcomes Assessor)

盲法说明

Double-blinded (Participants and Outcome Assessors)

入排标准

年龄范围: 18 Years 至 65 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•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

排除标准

•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

研究组 & 干预措施

Group A: Pre-intubation oropharyngeal topical %10 lidocaine

Experimental

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

干预措施: Optic nerve sheath diameter measurement 0 (Diagnostic Test)

Group A: Pre-intubation oropharyngeal topical %10 lidocaine

Experimental

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

干预措施: optic nerve sheath diameter measurement 1 (Diagnostic Test)

Group A: Pre-intubation oropharyngeal topical %10 lidocaine

Experimental

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

干预措施: optic nerve sheath diameter measurement 2 (Diagnostic Test)

Group A: Pre-intubation oropharyngeal topical %10 lidocaine

Experimental

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

干预措施: optic nerve sheath diameter measurement 3 (Diagnostic Test)

Group A: Pre-intubation oropharyngeal topical %10 lidocaine

Experimental

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

干预措施: Pre-intubation oropharyngeal topical %10 lidocaine (Procedure)