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COMPARISON OF AIRWAY NERVE BLOCK VERSUS NEBULIZED LIDOCAINE ON HEMODYNAMIC RESPONSES DURING AWAKE FIBEROPTIC INTUBATION

2026年5月30日更新者：Aniqa Intizar、Mayo Hospital Lahore

COMPARISON OF AIRWAY NERVE BLOCK VERSUS NEBULIZED LIDOCAINE ON HEMODYNAMIC RESPONSES DURING AWAKE FIBEROPTIC INTUBATION, A RANDOMIZED CONTROLLED TRIAL

This prospective randomized controlled trial aims to compare the effectiveness of airway nerve blocks versus nebulized lidocaine in attenuating hemodynamic responses during awake fiberoptic intubation in adult patients with anticipated difficult airways. Eighty patients undergoing elective surgery requiring awake fiberoptic intubation will be randomly assigned to receive either airway nerve blocks (glossopharyngeal and transtracheal blocks with lidocaine) or nebulized lidocaine. The primary outcome will be changes in heart rate and mean arterial pressure during and after intubation. Secondary outcomes include intubation conditions, patient comfort, cough severity, intubation time, and procedure-related complications. The study aims to identify the most effective airway anesthesia technique for maintaining hemodynamic stability and improving patient tolerance during awake fiberoptic intubation.

研究概览

地位

尚未招聘

条件

干预/治疗

研究类型

介入性

注册 (估计的)

阶段

不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

姓名：Aniqa Intizar
电话号码：+923349872530
邮箱：aniqaintizar1040@gmail.com

研究联系人备份

姓名：Ijaz Khalid
电话号码：+923008579196
邮箱：ejazrao@outlook.com

学习地点

巴基斯坦
- Punjab Province
  - Lahore、Punjab Province、巴基斯坦、54000
    - Mayo Hospital, Lahore

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

成人
年长者

接受健康志愿者

不

描述

Inclusion Criteria:

Adults aged 18 to 65 years. American Society of Anesthesiologists (ASA) physical status I-III. Scheduled for elective surgery requiring awake fiberoptic intubation. Anticipated difficult airway. Able and willing to provide written informed consent

Exclusion Criteria:

Known allergy or hypersensitivity to lidocaine or other local anesthetics. Coagulopathy or bleeding disorders. Severe respiratory disease. Hemodynamic instability. Pregnancy. Refusal to participate in the study. Inability to cooperate with awake fiberoptic intubation or study procedures

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

主要用途：治疗
分配：随机化
介入模型：并行分配
屏蔽：单身的

手臂数量

武器和干预

参与者组/臂	干预/治疗
实验性的：Nebulized Lidocaine Participants allocated to this arm will receive airway topical anesthesia using 4% lidocaine administered via nebulization for 15 minutes before awake fiberoptic intubation. All participants will receive standardized intravenous sedation with midazolam and nalbuphine. Awake fiberoptic intubation will then be performed by an experienced anesthesiologist. Hemodynamic parameters, including heart rate and mean arterial pressure, will be recorded at baseline, during intubation, and at 1, 3, and 5 minutes after intubation. Additional outcomes including intubation time, patient comfort, cough severity, and procedure-related complications will be assessed.	药品：Nebulized Lidocaine Participants will receive 4% lidocaine administered via nebulization for 15 minutes before awake fiberoptic intubation to provide topical airway anesthesia and suppress airway reflexes during the procedure.
实验性的：Nerve Block Participants allocated to this arm will receive airway anesthesia using bilateral glossopharyngeal nerve block and transtracheal block with 2% lidocaine prior to awake fiberoptic intubation. All participants will receive standardized intravenous sedation with midazolam and nalbuphine. Awake fiberoptic intubation will then be performed by an experienced anesthesiologist. Hemodynamic parameters, including heart rate and mean arterial pressure, will be recorded at baseline, during intubation, and at 1, 3, and 5 minutes after intubation. Secondary outcomes including intubation time, patient comfort score, cough severity, and procedure-related complications will also be assessed.	程序：Nerve Block Participants will receive airway anesthesia using bilateral glossopharyngeal nerve block and transtracheal block with 2% lidocaine before awake fiberoptic intubation to provide airway anesthesia and suppress airway reflexes during the procedure.

参与者组/臂

干预/治疗

实验性的：Nebulized Lidocaine

Participants allocated to this arm will receive airway topical anesthesia using 4% lidocaine administered via nebulization for 15 minutes before awake fiberoptic intubation. All participants will receive standardized intravenous sedation with midazolam and nalbuphine. Awake fiberoptic intubation will then be performed by an experienced anesthesiologist. Hemodynamic parameters, including heart rate and mean arterial pressure, will be recorded at baseline, during intubation, and at 1, 3, and 5 minutes after intubation. Additional outcomes including intubation time, patient comfort, cough severity, and procedure-related complications will be assessed.

药品：Nebulized Lidocaine

Participants will receive 4% lidocaine administered via nebulization for 15 minutes before awake fiberoptic intubation to provide topical airway anesthesia and suppress airway reflexes during the procedure.

实验性的：Nerve Block

Participants allocated to this arm will receive airway anesthesia using bilateral glossopharyngeal nerve block and transtracheal block with 2% lidocaine prior to awake fiberoptic intubation. All participants will receive standardized intravenous sedation with midazolam and nalbuphine. Awake fiberoptic intubation will then be performed by an experienced anesthesiologist. Hemodynamic parameters, including heart rate and mean arterial pressure, will be recorded at baseline, during intubation, and at 1, 3, and 5 minutes after intubation. Secondary outcomes including intubation time, patient comfort score, cough severity, and procedure-related complications will also be assessed.

程序：Nerve Block

Participants will receive airway anesthesia using bilateral glossopharyngeal nerve block and transtracheal block with 2% lidocaine before awake fiberoptic intubation to provide airway anesthesia and suppress airway reflexes during the procedure.

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
Mean Arterial Pressure (MAP) Change During Awake Fiberoptic Intubation 大体时间：Baseline to 5 minutes after intubation.	Change in mean arterial pressure from baseline measured during intubation and at 1, 3, and 5 minutes after awake fiberoptic intubation.	Baseline to 5 minutes after intubation.
Heart Rate Change During Awake Fiberoptic Intubation 大体时间：Baseline to 5 minutes after intubation.	Change in heart rate from baseline measured during intubation and at 1, 3, and 5 minutes after awake fiberoptic intubation.	Baseline to 5 minutes after intubation.

次要结果测量

结果测量	措施说明	大体时间
Intubation Time 大体时间：During the intubation procedure.	Time from insertion of the fiberoptic bronchoscope until confirmation of successful endotracheal tube placement.	During the intubation procedure.
Patient Comfort Score 大体时间：Immediately after completion of awake fiberoptic intubation.	Patient comfort assessed using a standardized 5-point tolerance scale.	Immediately after completion of awake fiberoptic intubation.
Cough Severity Score 大体时间：During the intubation procedure.	Severity of coughing during awake fiberoptic intubation assessed using a predefined cough scoring system.	During the intubation procedure.
Successful Intubation Rate 大体时间：From intervention administration until 5 minutes after intubation.	Successful placement of an endotracheal tube without the need for rescue airway anesthesia.	From intervention administration until 5 minutes after intubation.
Procedure-Related Complications 大体时间：From intervention administration until 5 minutes after intubation.	Incidence of adverse events including airway trauma, desaturation, allergic reactions, hoarseness, or other procedure-related complications.	From intervention administration until 5 minutes after intubation.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Mayo Hospital Lahore

调查人员

首席研究员：Aniqa Intizar、Mayo Hospital Lahore

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年6月28日

初级完成 (估计的)

2027年6月1日

研究完成 (估计的)

2027年8月1日

研究注册日期

首次提交

2026年5月30日

首先提交符合 QC 标准的

2026年5月30日

首次发布 (实际的)

2026年6月4日

研究记录更新

最后更新发布 (实际的)

2026年6月4日

上次提交的符合 QC 标准的更新

2026年5月30日

最后验证

2026年4月1日

COMPARISON OF AIRWAY NERVE BLOCK VERSUS NEBULIZED LIDOCAINE ON HEMODYNAMIC RESPONSES DURING AWAKE FIBEROPTIC INTUBATION