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Airway Complication of AnesthesiaPhase 3NCT06720220

Role of Airway Topicalization in Awake Fiberoptic Intubation

A Phase 3 study testing Dexmedetomidine Hydrochloride, Nebulization and Atomization in people with Airway Complication of Anesthesia, run by Zagazig University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 21 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Airway Complication of Anesthesia
What is being tested?
Dexmedetomidine Hydrochloride, Nebulization and Atomization
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
56 participants
Where
1 siteEgypt
Study dates
1 Jun 2023to 1 Sep 2024
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Faculty of medicine - Zagazig University

    Zagazig, Alsharkia, 44511

Other trials in Egypt

About this study

Official title: Sedation Using Dexmedetomidine With or Without Different Methods of Airway Topical Anesthesia for Awake Fiberoptic Nasal Intubation in Patients Undergoing Elective Surgeries Under General Anesthesia

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.

Read more

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.

Read the detailed description

-Type of the Study: Prospective randomized double-blind controlled clinical trial.

  • Randomization: 56 patients were included in this prospective randomized double-blind controlled clinical study. They were randomized by computer-generated randomization table into 4 equal groups (14 patients each):
  • Group C (Sedation / Control group) (n=14) patients received only dexmedetomidine as a sedative with placebo airway topicalization by nebulization, atomization, and spray as you go using normal saline 0.9%.
  • Group N (Nebulization group) (n=14) patients received 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%.
  • Group A (Atomization group) (n=14) patients received 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%.
  • Group S (SAYGo group) (n=14) patients received 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%.

A well-trained nurse prepared different topicalization methods according to each group. The anesthesiologist who performed the awake fiberoptic nasal intubation and followed the perioperative data was unaware of each preparation, as well as the patient to ensure blindness of the study.

  • Preoperative Preparation:

The day before surgery, all participating patients were interviewed, the procedure of awake fiberoptic intubation was explained and a written informed consent was obtained from each patient. General and airway examination was done to rule out any contraindication. All patients were investigated by complete blood count, liver function tests, kidney function tests, and coagulation profile. All patients were kept fasting for minimum of 2 hours for clear liquids and 6 hours for solid food before the operation.

On the day of surgery, in the pre-anesthesia room, two 20-gauge cannulae were inserted, secured and maintenance intravenous fluid (ringer lactate) infusion was started via one of them while the other for continuous infusion of sedative drug.

Premedication was done with atropine 1 mg I.M. and metoclopramide 10 mg I.V. 1 hour before conducting the technique. Xylometazoline hydrochloride decongestant nasal drops and lignocaine gel 2% were applied in both nasal passages. A gauze soaked in 10 ml lidocaine 2% was placed in the oral cavity for 10 minutes.

  • Intraoperative:

On arrival to the operating room, standard monitoring including non-invasive blood pressure, electrocardiogram, and pulse oximetry was performed on all patients. Baseline readings of mean arterial pressure, heart rate, and oxygen saturation were recorded. Supplemental oxygen was administered at 6-8 L/min via nasal prongs through patient's mouth.

Sedation technique:

All patients in all groups received procedural sedation by I.V. infusion of dexmedetomidine. It was prepared as 200 µg (2 ml) of dexmedetomidine added to 48 ml of 0.9% saline. A loading dose of dexmedetomidine 0.5 to 1 µg/kg was given over 10- 20 minutes, followed by 0.2-0.7 µg/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 response to commands (equivalent to a Modified Ramsay Sedation Scale score of 3). The total dose of dexmedetomidine used to reach this point of sedation in each group was calculated and recorded.

Nebulization Technique:

Patients in the nebulization group received procedural sedation by I.V. infusion of dexmedetomidine as mentioned before, then they had a 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. (200 mg of which 25% is typically absorbed = 50 mg) into the nasopharynx \& oropharynx.

The patient was asked to take shallow breaths to topicalize the more proximal airway and to take slow deep breaths for the more distal airway. This process may need repeating to ensure adequate airway anesthesia. Adequate topical anesthesia was confirmed by heaviness or numbness of the tongue.

To rule out bias, nebulization was done using 10 ml of normal saline 0.9% to patients in other groups.

Atomization technique:

Patients in the atomization group received procedural sedation by I.V. infusion of dexmedetomidine as mentioned before, then they were subjected to airway topicalization by atomization (through a modification of the McKenzie technique). This modification utilizes a suction catheter instead of a 20-gauge cannula (to allow the local anesthetic drug to topicalize the more distal airway creating a jet-like spray of local anesthetic towards airway mucosa). 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 the top port of the three-way stopcock

As the local anesthetic was administered via the syringe, a jet-like spray was created to enable effective topicalization of the nasal and oral mucosa. The spray should be targeted to the nasal passage, soft palate, uvula, base of tongue and posterior pharyngeal wall. The patient was asked to spit out or swallow the local anesthetic after gargling. Once swallowed it is removed by liver following first pass metabolism without adverse effects.

To rule out bias, atomization was done using 10 ml normal saline 0.9% to patients in other groups.

Spray as you go (SAYGo) Technique:

Patients in the SAYGo group received procedural sedation by I.V. infusion of dexmedetomidine as mentioned before, then they were subjected to 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 and into the pharynx. Then 10-ml syringe containing 10 ml Lidocaine 2%, was attached directly to the working channel, and thus the local anesthetic was sprayed to target the mucosa of the postnasal space and back of the throat, as the fiberscope was advanced through the airway.

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 patients are informed that they may cough. If the patient coughs, it is prudent to wait until the view clears.

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.

Awake Nasotracheal Fiberoptic Intubation Technique:

After the patient prepared with sedation either alone or with airway topicalization, the patient's head was positioned neutrally or slightly extended. The Fiberoptic Bronchoscope preloaded with an appropriate size endotracheal tube (size 7.0 mm internal diameter for male patients and size 6.5 mm for female patients) was lubricated with water-soluble gel to decrease friction and facilitate insertion. The tip of the fiberoptic bronchoscope was inserted into the more patent nostril and advanced through the nasal passage, entering the pharynx, then the tip of the scope was deflected upward till the epiglottis was seen in the midline. The scope was advanced beneath the epiglottis till the vocal cords were visualized. The patient was asked to take a deep breath so the scope could pass between the vocal cords observing the tracheal rings and reaching the carina. Then the patient was asked to take a deep breath, the lubricated endotracheal tube "preloaded on the scope" at the entrance to the nose is rotated through the nose and into the trachea along the fiberoptic bronchoscope. The patient was informed that this may be uncomfortable.

Once the tube had successfully been passed into the trachea, its depth was noted, verifying that the tube is in the trachea by observing the carina and the scope was finally removed.

In all groups, once the tube position was confirmed (using a stethoscope and capnography), the patient was anesthetized using propofol 2 mg/kg i.v, rocuronium 0.6-0.9 mg/kg i.v and the cuff of the endotracheal tube was inflated. Anesthesia was maintained with inhalation of oxygen and isoflurane 1.5% minimal alveolar concentration (MAC), rocuronium 0.15 mg/kg i.v increments and the surgical procedure was proceeded as planned.

Patients' intubation condition was assessed by:

  1. Five-point fiberoptic intubation comfort score during bronchoscopy as follows: (0: no reaction, 1: slight grimacing, 2: heavy grimacing, 3: verbal objection, 4: defensive movements).
  2. patients' behavior was assessed using three-point behavior score immediately after intubation as follows: (0: cooperative, 1: restless/minimal resistance, 2: severe resistance).
  3. Bronchoscopy-guided intubation time (from the insertion of the fiberoptic bronchoscope in the nostril to confirmation of tracheal intubation by capnography).

Vital parameters (MAP, HR) and oxygen saturation (SpO2%) were continuously monitored \& recorded immediately after intubation, every 5 min during the 1st 15 min then every 15 min till 1 hour. Any changes in MAP, HR or any hypoxic episode (SpO2 <90%) during intubation were recorded.

Four-point patient satisfaction score (0: excellent, 1: good, 2: reasonable, 3: poor) was used to assess patient satisfaction post-operatively.

Postoperative adverse events such as sore throat, hoarseness or any signs of lidocaine toxicity such as ECG changes, seizures, and bronchoconstriction were noted.

Being tested
Dexmedetomidine Hydrochloride, Nebulization, Atomization, Spray-As-You-Go
Keywords
Dexmedetomidine, Airway Topicalization, AFOI

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dexmedetomidine HydrochlorideDrug

    Also called Precedex

    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).

  • NebulizationOther

    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.

  • AtomizationOther

    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

  • Spray-As-You-GoOther

    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.

Study groups in NCT06720220
Study groupRoleWhat they receive
Group C (Sedation / Control group)Placebo comparatorThe 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%.
Receives: Drug: Dexmedetomidine Hydrochloride
Group N (Nebulization group)Active comparatorThe 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%.
Receives: Drug: Dexmedetomidine Hydrochloride; Other: Nebulization
Group A (Atomization group)Active comparatorThe 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%.
Receives: Drug: Dexmedetomidine Hydrochloride; Other: Atomization
Group S (SAYGo group)Active comparatorThe 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%.
Receives: Drug: Dexmedetomidine Hydrochloride; Other: Spray-As-You-Go

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: 1 - 3 hours

Secondary outcomes (4)
  1. Calculation of the total dexmedetomidine dose used for sedation

    the total dexmedetomidine dose used during the procedure

    Measured: 20 minutes

  2. Peri-intubation measurement of mean arterial pressure .

    measurement of the mean arterial pressure every 2 minutes for the first hour.

    Measured: 1 hour

  3. Peri-intubation measurement of heart rate.

    measurement of the heart rate every 2 minutes for the first hour.

    Measured: 1 hour

  4. Evaluation the post-operative patient satisfaction

    Evaluating the post-operative patient satisfaction by the Four-point patient satisfaction Likert scale

    Measured: 1 hour

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Dec 2024
  2. Study start1 Jun 2023
  3. Primary completion29 Aug 2024
  4. Study completion1 Sep 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
56 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06720220
Sponsor's protocol ID
Airway topicalization
Status last verified
Dec 2024
First submitted
11 Jul 2024
Last updated
20 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Dexmedetomidine Hydrochloride, Nebulization and Atomization in people with Airway Complication of Anesthesia, run by Zagazig University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Assessment of patients' intubation condition during awake fiberoptic intubation. (time frame: 1 - 3 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2025.

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