Role of Airway Topicalization in Awake Fiberoptic Intubation

NCT06720220 | Completed Phase 3

• 1 other identifier: Airway topicalization
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Dexmedetomidine, Airway Topicalization, AFOI

Outcome Measures

Primary Outcomes (1)

• Assessment of patients' intubation condition during awake fiberoptic intubation.

  The patients' intubation condition is assessed by the Five-point fiberoptic intubation comfort score

  1 - 3 hours

Secondary Outcomes (4)

• Calculation of the total dexmedetomidine dose used for sedation

  20 minutes

• Peri-intubation measurement of mean arterial pressure .

  1 hour

• Peri-intubation measurement of heart rate.

  1 hour

• Evaluation the post-operative patient satisfaction

  1 hour

Study Arms (4)

Group C (Sedation / Control group)

PLACEBO COMPARATOR

The patients will receive only dexmedetomidine as a sedative for AFOI with placebo airway topicalization by nebulization, atomization and spray as you go using normal saline 0.9%.

Drug: Dexmedetomidine Hydrochloride

Group N (Nebulization group)

ACTIVE COMPARATOR

The patients will receive dexmedetomidine as a sedative in addition to lidocaine 2% nebulization for airway topicalization and placebo airway topicalization by atomization and "spray as you go" using normal saline 0.9%.

Drug: Dexmedetomidine Hydrochloride; Other: Nebulization

Group A (Atomization group)

ACTIVE COMPARATOR

The patients will receive dexmedetomidine as a sedative in addition to lidocaine 2% by atomization "modified McKenzie technique" and placebo airway topicalization by nebulization and "spray as you go" using normal saline 0.9%.

Drug: Dexmedetomidine Hydrochloride; Other: Atomization

Group S (SAYGo group)

ACTIVE COMPARATOR

The patients will receive dexmedetomidine as a sedative in addition to lidocaine 2% by "Spray as You Go" technique and placebo airway topicalization by atomization and nebulization using normal saline 0.9%.

Drug: Dexmedetomidine Hydrochloride; Other: Spray-As-You-Go

Interventions

Dexmedetomidine Hydrochloride DRUG

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).

Also known as: Precedex

Group A (Atomization group); Group C (Sedation / Control group); Group N (Nebulization group); Group S (SAYGo group)

Nebulization OTHER

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.

Group N (Nebulization group)

Atomization OTHER

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

Group A (Atomization group)

Spray-As-You-Go OTHER

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.

Group S (SAYGo group)

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patient acceptance and willingness to sign a written informed consent document.
• Body mass index (BMI): 18.5 - 24.9 kg/m2.
• American Society of Anesthesiologists physical status: class I \& II.
• patients undergoing elective surgery under general anesthesia.

You may not qualify if:

• Patient refusal.
• Patients with known allergies to study drugs.
• Patients having any contraindication to nasal intubation; nasal bleeding or infection.
• Patients having bleeding disorders.
• Reactive airway disease.

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Faculty of medicine - Zagazig University

Zagazig, Alsharkia, 44511, Egypt

Location

MeSH Terms

Interventions

Dexmedetomidine

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Howaida Kamal Abdellatif, MD

  Professor of Anesthesia, Intensive Care and pain management

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2024
• First Posted: December 6, 2024
• Study Start: June 1, 2023
• Primary Completion: August 29, 2024
• Study Completion: September 1, 2024
• Last Updated: July 20, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)