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.
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
- Type of treatment
- Pill or oral medicine, Injection or infusion
- 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.
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:
- 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).
- patients' behavior was assessed using three-point behavior score immediately after intubation as follows: (0: cooperative, 1: restless/minimal resistance, 2: severe resistance).
- 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.
- Conditions
- Airway Complication of Anesthesia
- 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 group | Role | What they receive |
|---|---|---|
| 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%. Receives: 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%. Receives: 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%. Receives: 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%. 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.
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)
Calculation of the total dexmedetomidine dose used for sedation
the total dexmedetomidine dose used during the procedure
Measured: 20 minutes
Peri-intubation measurement of mean arterial pressure .
measurement of the mean arterial pressure every 2 minutes for the first hour.
Measured: 1 hour
Peri-intubation measurement of heart rate.
measurement of the heart rate every 2 minutes for the first hour.
Measured: 1 hour
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.
- First posted6 Dec 2024
- Study start1 Jun 2023
- Primary completion29 Aug 2024
- Study completion1 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Airway Complication of AnesthesiaStudies of the same condition, open and under way.
- More trials run by Zagazig UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Howaida Kamal Abdellatif, MD, Study director, Professor of Anesthesia, Intensive Care and pain management
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
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06720220
- Acronym / sponsor ID
- Airway topicalization
- Conditions
- Airway Complication of Anesthesia
- Keywords
- Dexmedetomidine, Airway Topicalization, AFOI
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 29 Aug 2024 (actual)
- Study completion
- 1 Sep 2024 (actual)
- First posted
- 6 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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).
- patients' behavior was assessed using three-point behavior score immediately after intubation as follows: (0: cooperative, 1: restless/minimal resistance, 2: severe resistance).
- 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group C (Sedation / Control group) | Placebo comparator | Drug: Dexmedetomidine HydrochlorideThe 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%. |
| Group N (Nebulization group) | Active comparator | Drug: Dexmedetomidine Hydrochloride, Other: NebulizationThe 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%. |
| Group A (Atomization group) | Active comparator | Drug: Dexmedetomidine Hydrochloride, Other: AtomizationThe 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%. |
| Group S (SAYGo group) | Active comparator | Drug: Dexmedetomidine Hydrochloride, Other: Spray-As-You-GoThe 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%. |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexmedetomidine HydrochlorideAlso: Precedexprocedural 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). | Drug | Group A (Atomization group), Group C (Sedation / Control group), Group N (Nebulization group), Group S (SAYGo group) |
| Nebulizationnebulization 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 | Group N (Nebulization group) |
| AtomizationAirway 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 | Group A (Atomization group) |
| Spray-As-You-Goairway 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. | Other | Group S (SAYGo group) |
Primary outcome
Assessment of patients' intubation condition during awake fiberoptic intubation.
Time frame: 1 - 3 hours
The patients' intubation condition is assessed by the Five-point fiberoptic intubation comfort score
4 secondary outcomes
Calculation of the total dexmedetomidine dose used for sedation
Time frame: 20 minutes
Peri-intubation measurement of mean arterial pressure .
Time frame: 1 hour
Peri-intubation measurement of heart rate.
Time frame: 1 hour
Evaluation the post-operative patient satisfaction
Time frame: 1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Howaida Kamal Abdellatif, MD study director
Professor of Anesthesia, Intensive Care and pain management
1 site in 1 country: see every site and its status.
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.