NebulizationNCT06088875
Nebulization Versus Spray-as-You-Go Airway Topical Anesthesia Using Dexmedetomidine and Lidocaine Mixture During Awake Flexible Fiberoptic Intubation in Temporomandibular Ankylosis
A study testing Nebulization and Spray-as-you-go in people with Nebulization and Spray-as-You-Go, run by Tanta University at 1 site in Egypt.
Trial summary
The aim of this study is to compare the efficacy of airway topical anesthesia with nebulization to the spray-as-you-go technique using dexmedetomidine and lidocaine mixture to achieve upper airway anesthesia in TMJ ankylosis patients. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Nebulization, Spray-as-You-Go, Dexmedetomidine
- What is being tested?
- Nebulization and Spray-as-you-go
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 18 Oct 2023to 1 May 2024
- Phase
- Interventional
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age from 21to 65 years.
- Both sexes.
- American Society of Anesthesiologists (ASA) physical status I or II and scheduled for elective surgery requiring general anesthesia , and known to have Temporomandibular joint ankylosis and expected to be difficult intubation patient due to restriction of jaw mobility and limited mouth opening less than 2 fingers.
Who cannot join
- History of allergy to dexmedetomidine or lidocaine.
- History of drug abuse.
- Concomitant use of medications which may exaggerate the heart rate (HR) response of -dexmedetomidine (e.g. digoxin or β-adrenergic antagonists), HR <50 beats/min, systolic blood pressure (SBP) <90 mmHg.
- Pregnancy.
- Morbid obesity( BMI more than 35).
- Patients on anticoagulants, nasal trauma, deformity or polyp, CSF rhinorrhea, fracture base skull.
- Cardiac and/or respiratory disease, reactive airway disease, hepatic or renal disorders.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Tanta University
Tanta, El-Gharbia, 31527
Mahmoud H El-Baradei, MBBCH, 00201150242991, mahmoud.elbaradei74@gmail.com
Ahmed S El-gebaly, MD
About this study
Official title: Nebulization Versus Spray-as-You-Go Airway Topical Anesthesia Using Dexmedetomidine and Lidocaine Mixture During Awake Flexible Fiberoptic Intubation in Temporomandibular Ankylosis: A Randomized Double-Blind Trial
The aim of this study is to compare the efficacy of airway topical anesthesia with nebulization to the spray-as-you-go technique using dexmedetomidine and lidocaine mixture to achieve upper airway anesthesia in TMJ ankylosis patients.
Read the detailed description
Awake fiber-optic intubation (AFOI) has become the accepted gold standard technique for management of recognized difficult airway as the larynx remains in a posterior position and the patient is able to protect the airway from soiling and can maintain the airway patency as well as spontaneous breathing efforts. Awake intubation requires that the patient remains calm and cooperative and is provided with sufficient anxiolysis, analgesia, and topical anesthesia without compromising the airway.
Gag reflex, cough, and laryngospasm can be upsetting during the process. Awake patients never permit airway instrumentation without airway anesthesia. Therefore, effective airway anesthesia is required for airway instrumentation and patient comfort.
For awake intubation, topical airway anesthesia can be provided either by using fiberoptic bronchoscope (FOB) to apply local anaesethic to the airway by a "spray-as-you-go" technique or nebulizing the patient for about 10-15 min.
- Being tested
- Nebulization, Spray-as-you-go
- Medical subject headings
- Temporomandibular ankylosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NebulizationDrug
Patients will be nebulized with mixture of 2% lidocaine 10 ml and dexmedetomidine 1 μg/kg by using wall nebulizer for 15 min before awake fiberoptic intubation. Patients in group S will receive saline 10 ml nebulization
Spray-as-you-goDrug
Patients will receive a mixture of 2% lidocaine 10 ml and dexmedetomidine 1 μg/kg via spray-as-you-go technique + saline 10 ml nebulization. Patients in group N will receive saline via spray-as-you-go technique
| Study group | Role | What they receive |
|---|---|---|
| Group N (Nebulization group) | Experimental | Patients will receive a mixture of 2% lidocaine 10 ml and dexmedetomidine 1 μg/kg nebulization + saline 10 ml via spray-as-you-go technique. Receives: Drug: Nebulization |
| Group S (Spray-as-you-go) | Experimental | Patients will receive a mixture of 2% lidocaine 10 ml and dexmedetomidine 1 μg/kg via spray-as-you-go technique + saline 10 ml nebulization. Receives: Drug: Spray-as-you-go |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ease of successful intubation
Ease of successful intubation will be measured by the composite score which is a composite of five parameters with a score of 1-5 for each parameter, 1 indicating best possible condition and higher scores indicating worsening of the conditions for intubation . The maximum score was 25. A score of <10 was considered optimal, 10-15
Measured: Immediately after intubation
Secondary outcomes (3)
Adverse events.
Adverse events (bradycardia, hypotension, laryngeal spasm, lidocaine toxicity). Hypotension (MAP < 20% of baseline readings ). Bradycardia (HR < 50 beats/min
Measured: From intervention for 4hours
Time till successful intubation.
Time needed till successful intubation. Direct visualization of the endotracheal tube passing through the vocal cords into the trachea.
Measured: Immediately after intubation
Post-operative sore throat.
Sore throat will be evaluated at PACU 1, 12 and 24h after extubation, during the post-operative period.
Grading of Post-operative sore throat (POST) will be done using a four-point scale (0-3) : 0 for no sore throat; 1 for mild sore throat (complains of sore throat only when asked); 2 for moderate sore throat (complains of sore throat even without asking); and 3 for severe sore throat (with change of voice or hoarseness, also may be associated with throat pain).
Measured: 24 hours after extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2023
- Study start18 Oct 2023
- Primary completion1 May 2024 (estimated)
- Study completion1 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NebulizationStudies of the same condition, open and under way.
- More trials run by Tanta 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Hassan El-Baradei, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06088875
- Sponsor's protocol ID
- 36264MS159/4/23
- Status last verified
- Oct 2023
- First submitted
- 3 Oct 2023
- Last updated
- 19 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nebulization Versus Spray-as-You-Go Airway Topical Anesthesia Using Dexmedetomidine and Lidocaine Mixture During Awake Flexible Fiberoptic Intubation in Temporomandibular Ankylosis: A Randomized Double-Blind Trial
- ClinicalTrials.gov ID
- NCT06088875
- Acronym / sponsor ID
- 36264MS159/4/23
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 18 Oct 2023 (actual)
- Primary completion
- 1 May 2024 (estimated)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 18 Oct 2023 (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.
The aim of this study is to compare the efficacy of airway topical anesthesia with nebulization to the spray-as-you-go technique using dexmedetomidine and lidocaine mixture to achieve upper airway anesthesia in TMJ ankylosis patients.
Detailed description
Awake fiber-optic intubation (AFOI) has become the accepted gold standard technique for management of recognized difficult airway as the larynx remains in a posterior position and the patient is able to protect the airway from soiling and can maintain the airway patency as well as spontaneous breathing efforts. Awake intubation requires that the patient remains calm and cooperative and is provided with sufficient anxiolysis, analgesia, and topical anesthesia without compromising the airway.
Gag reflex, cough, and laryngospasm can be upsetting during the process. Awake patients never permit airway instrumentation without airway anesthesia. Therefore, effective airway anesthesia is required for airway instrumentation and patient comfort.
For awake intubation, topical airway anesthesia can be provided either by using fiberoptic bronchoscope (FOB) to apply local anaesethic to the airway by a "spray-as-you-go" technique or nebulizing the patient for about 10-15 min.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group N (Nebulization group) | Experimental | Drug: NebulizationPatients will receive a mixture of 2% lidocaine 10 ml and dexmedetomidine 1 μg/kg nebulization + saline 10 ml via spray-as-you-go technique. |
| Group S (Spray-as-you-go) | Experimental | Drug: Spray-as-you-goPatients will receive a mixture of 2% lidocaine 10 ml and dexmedetomidine 1 μg/kg via spray-as-you-go technique + saline 10 ml nebulization. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age from 21to 65 years.
- Both sexes.
- American Society of Anesthesiologists (ASA) physical status I or II and scheduled for elective surgery requiring general anesthesia , and known to have Temporomandibular joint ankylosis and expected to be difficult intubation patient due to restriction of jaw mobility and limited mouth opening less than 2 fingers.
Key exclusion criteria (7 listed)
- History of allergy to dexmedetomidine or lidocaine.
- History of drug abuse.
- Concomitant use of medications which may exaggerate the heart rate (HR) response of -dexmedetomidine (e.g. digoxin or β-adrenergic antagonists), HR <50 beats/min, systolic blood pressure (SBP) <90 mmHg.
- Pregnancy.
- Morbid obesity( BMI more than 35).
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 |
|---|---|---|
| NebulizationPatients will be nebulized with mixture of 2% lidocaine 10 ml and dexmedetomidine 1 μg/kg by using wall nebulizer for 15 min before awake fiberoptic intubation. Patients in group S will receive saline 10 ml nebulization | Drug | Group N (Nebulization group) |
| Spray-as-you-goPatients will receive a mixture of 2% lidocaine 10 ml and dexmedetomidine 1 μg/kg via spray-as-you-go technique + saline 10 ml nebulization. Patients in group N will receive saline via spray-as-you-go technique | Drug | Group S (Spray-as-you-go) |
Primary outcome
Ease of successful intubation
Time frame: Immediately after intubation
Ease of successful intubation will be measured by the composite score which is a composite of five parameters with a score of 1-5 for each parameter, 1 indicating best possible condition and higher scores indicating worsening of the conditions for intubation . The maximum score was 25. A score of <10 was considered optimal, 10-15
3 secondary outcomes
Adverse events.
Time frame: From intervention for 4hours
Time till successful intubation.
Time frame: Immediately after intubation
Post-operative sore throat.
Time frame: 24 hours after extubation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2023.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Related trials for Nebulization
RecruitingPhase 2
Phase 2b Efficacy and Safety Study of AERO-007, an Inhaled LABA+LAMA Combination for Nebulization Delivery in COPD Patients
COPD, Chronic Obstructive Pulmonary Disease (COPD)
RecruitingPhase 1/2
CaspoNEB: Efficacy and Safety of Caspofungin Aerosols for the Curative Treatment of Pneumocystis Pneumonia
Pneumocystis Pneumonia, Pneumocystis Jirovecii Infection
Not yet recruitingPhase 2/3
Nebulised Colistimethate Sodium to Prevent Pediatric Ventilator-associated Pneumonia
Ventilator Associated Pneumonia
Not yet recruitingPhase 4
Tobramycin Nebulization to Prevent Multidrug-Resistant Ventilator-Associated Pneumonia
Pneumonia, Ventilator-Associated
RecruitingEarly Phase 1
YSCH-01 Via Nebulization in Pulmonary Metastasis of Advanced Solid Tumors and Non-small Cell Lung Cancer (NSCLC)
NSCLC, Advanced Solid Tumor
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nebulization and Spray-as-you-go in people with Nebulization and Spray-as-You-Go, run by Tanta 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 3 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 19 Oct 2023. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mahmoud H El-Baradei, MBBCH (00201150242991, mahmoud.elbaradei74@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ease of successful intubation (time frame: Immediately after intubation). 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 19 Oct 2023.