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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Blood Pressure After Nerve Block; Hemodynamic Stability During Awake Intubation
• Intervention / Treatment: Drug: Nebulized Lidocaine; Procedure: Nerve Block

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Aniqa Intizar; Phone Number: +923349872530; Email: aniqaintizar1040@gmail.com
• Study Contact Backup: Name: Ijaz Khalid; Phone Number: +923008579196; Email: ejazrao@outlook.com

Study Locations

• Pakistan
  • Punjab Province
    • Lahore, Punjab Province, Pakistan, 54000
      • Mayo Hospital, Lahore

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: 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.
Experimental: 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.	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Arterial Pressure (MAP) Change During Awake Fiberoptic 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	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.

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Mayo Hospital Lahore
• Investigators: Principal Investigator: Aniqa Intizar, Mayo Hospital Lahore

Study record dates

Study Major Dates

• Study Start (Estimated): June 28, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: May 30, 2026
• First Submitted That Met QC Criteria: May 30, 2026
• First Posted (Actual): June 4, 2026

Study Record Updates

• Last Update Posted (Actual): June 4, 2026
• Last Update Submitted That Met QC Criteria: May 30, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Hemodynamic; Nerve block; Fibreoptic; Awake intubation; Nebulized lignocaine
• Additional Relevant MeSH Terms: Surgical Procedures, Operative; Anesthesia and Analgesia; Neurosurgical Procedures; Anesthesia, Conduction; Anesthesia; Denervation; Nerve Block
• Other Study ID Numbers: Nerve Block Intubation

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

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