Role of Airway Topicalization in Awake Fiberoptic Intubation

NCT06720220 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2025-07-20

No results posted yet for this study

Summary

Airway management is an integral part of general anesthesia. Difficult airway management may lead to various adverse events such as airway trauma, up to cardiopulmonary arrest.

Awake fiberoptic intubation is the gold standard technique for difficult airway, although it can lead to significant patient anxiety and discomfort. Thus, it necessitates sufficient airway anesthesia for the patient's comfort and cooperation.

One challenge associated with this procedure is providing adequate anxiolysis while maintaining a patent airway and adequate ventilation. Suppressing airway reflexes represents another challenge to achieve successful airway management.

Sedation can be used during such procedures for better patient cooperation. The ideal sedative for awake intubation would provide patient comfort and good intubating conditions and at the same time maintain a patent airway.

Dexmedetomidine is a selective alpha-2-adrenoceptor agonist that can cause sedation, anxiolysis, sparing with minimal respiratory depression. It reduces the salivary secretion, which is advantageous for awake fiberoptic intubation.

Airway nerve blocks are considered technically difficult to perform and generally carry a higher risk of complications, including bleeding, nerve damage, and intravascular injection, but if performed by an experienced anesthesiologist, they would achieve excellent airway anesthesia for successful AFOI.

There are various airway topical techniques such as nebulization, atomization (McKenzie technique), and Spray-As-You- Go technique.

In the present study, we try to find out which is more effective for topicalization to achieve good intubating conditions in patients undergoing awake fiberoptic nasotracheal intubation using different methods of airway topicalization, nebulization, atomization or We used a modification of the McKenzie technique for atomization.

Conditions

  • Airway Complication of Anesthesia

Interventions

DRUG

Dexmedetomidine Hydrochloride

procedural sedation by I.V. infusion of dexmedetomidine. It was prepared as 200 ug (2 ml) of dexmedetomidine added to 48 ml of 0.9% saline. A loading dose of dexmedetomidine 0.5 to 1 ug/kg was given over 10- 20 minutes, followed by 0.2-0.7 ug/kg/hr as a continuous infusion by a syringe pump. During the dexmedetomidine infusion, a spontaneous respiratory pattern was maintained, and the level of sedation achieved to a point of semi-sleep but responds to commands (equivalent to Modified Ramsay Sedation Scale score of 3).

OTHER

Nebulization

nebulization session through a face mask nebulizer attached to an oxygen source. The nebulizer chamber was filled with 10 ml of 2% lidocaine (200 mg). The oxygen flow was adjusted at a rate of 8-10 L/min for 10-15 minutes.

OTHER

Atomization

Airway topicalization by atomization (through a modification of McKenzie technique). This modification utilizes a 10-Fr suction catheter instead of 20-gauge cannula. This suction catheter was attached to oxygen tubing with a three-way stopcock. The oxygen tubing was attached to an oxygen source, which delivers a flow of 2-4 L/min. A 10-ml syringe filled with 10 ml of lidocaine 2% was attached to top port of the three-way stopcock. Local anesthetic was injected via the syringe forming a jet- like spray for topicalization of the nasal and oral mucosa

OTHER

Spray-As-You-Go

airway topicalization method using the fiberoptic bronchoscope itself. The fiberoptic bronchoscope, preloaded with a 6.5 or 7 mm endotracheal tube, was passed under direct vision through the nose into the pharynx. Then 10-ml syringe containing 10 ml Lidocaine 2%, was attached to the working channel, and thus the local anesthetic was sprayed towards the mucosa of postnasal space and back of throat, while advancing the fiberscope. At the level of the epiglottis and around the vocal cords 2-4 ml of lidocaine 2% were sprayed toward these structures as the patient takes a deep breath to achieve sufficient anesthesia to the laryngeal inlet. The patient was asked to take another deep breath as the scope was passed through the vocal cords and 2 ml of lidocaine 2% is sprayed to the trachea and the scope was advanced further until the carina was visualized.

Sponsors & Collaborators

  • Zagazig University

    lead OTHER_GOV

Principal Investigators

  • Howaida Kamal Abdellatif, MD · Professor of Anesthesia, Intensive Care and pain management

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-06-01
Primary Completion
2024-08-29
Completion
2024-09-01

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06720220 on ClinicalTrials.gov