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

NCT07627100 | Not Yet Recruiting

• 1 other identifier: Nerve Block Intubation
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Blood Pressure After Nerve Block; Hemodynamic Stability During Awake Intubation

Keywords

Awake intubation; Nerve block; Nebulized lignocaine; Fibreoptic; Hemodynamic

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Intubation Time

  During the intubation procedure.

• Patient Comfort Score

  Immediately after completion of awake fiberoptic intubation.

• Cough Severity Score

  During the intubation procedure.

• Successful Intubation Rate

  From intervention administration until 5 minutes after intubation.

• Procedure-Related Complications

  From intervention administration until 5 minutes after intubation.

Study Arms (2)

Nebulized Lidocaine

EXPERIMENTAL

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

Nerve Block

EXPERIMENTAL

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

Interventions

Nebulized Lidocaine DRUG

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.

Nebulized Lidocaine

Nerve Block PROCEDURE

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.

Nerve Block

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Hospital Lahore: lead

Study Sites (1)

Mayo Hospital, Lahore

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Interventions

Nerve Block

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Denervation; Neurosurgical Procedures; Surgical Procedures, Operative

Study Officials

• Aniqa Intizar

  Mayo Hospital Lahore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aniqa Intizar

CONTACT

+923349872530; aniqaintizar1040@gmail.com

Ijaz Khalid

CONTACT

+923008579196; ejazrao@outlook.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 2
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: The Principal Investigator

Study Record Dates

• First Submitted: May 30, 2026
• First Posted: June 4, 2026
• Study Start: June 28, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: June 4, 2026

Record last verified: 2026-04

Locations

PA (1)