Lidocaine SprayNCT06563050
Comparison Between Different Ways for Using Lidocaine During FB
A study testing Nebulized lidocaine, Lidocaine spray and Combination of nebulized lidocaine and lidocaine spray in people with Lidocaine Spray and Nebulized Lidocaine, run by Assiut University.
Trial summary
compare the efficacy and safety of nebulized lidocaine, oropharyngeal lidocaine spray, or their combination for better outcome of topical anesthesia in subjects undergoing diagnostic FB; severity of cough , pain during procedure , cumulative dose of anesthesia needed and its adverse reaction , overall satisfaction . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lidocaine Spray, Nebulized Lidocaine, Lung Diseases
- What is being tested?
- Nebulized lidocaine, Lidocaine spray and Combination of nebulized lidocaine and lidocaine spray
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- No sites listed yet
- Study dates
- Sep 2024to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients above 18 years old will undergo FB are included in this study.
Who cannot join
- known hypersensitivity to lidocaine.
- Pregnancy.
- hemodynamic instability.
- failure to provide informed consent.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparison Between Nebulized Lidocaine, Lidocaine Spray, or Their Combination for Topical Anesthesia During Diagnostic Flexible Bronchoscopy: a Randomized Trial
compare the efficacy and safety of nebulized lidocaine, oropharyngeal lidocaine spray, or their combination for better outcome of topical anesthesia in subjects undergoing diagnostic FB; severity of cough , pain during procedure , cumulative dose of anesthesia needed and its adverse reaction , overall satisfaction .
Read the detailed description
Flexible bronchoscopy (FB) is a commonly performed procedure in the diagnosis and treatment of several respiratory disease. Although FB is generally a short procedure, it is uncomfortable for the patient. At least the use of topical anesthesia during FB is essential, especially when performed without sedation. Effective topical anesthesia blunts airway reflexes such as gag, cough, and laryngospasm.
The reduction in cough not only improves patient comfort but also makes the procedure easier for the operator.
Among agents used for topical anesthesia, lidocaine is the most widely used drug because of its safety and favorable pharmacokinetic profile.
Lidocaine is available in various formulations (gel or solution) and can be delivered to the respiratory passages by using different modes (spray, nebulization, transtracheal injection, bronchoscope instillation, and others).
In this study, will compare the efficacy and safety of nebulized lidocaine, oropharyngeal lidocaine spray, or their combination for topical anesthesia in subjects undergoing diagnostic FB, for better outcome.
- Conditions
- Lidocaine Spray, Nebulized Lidocaine, Lung Diseases, Lung Cancer
- Being tested
- Nebulized lidocaine, Lidocaine spray, Combination of nebulized lidocaine and lidocaine spray
- Keywords
- flexible bronchoscopy
- Medical subject headings
- Lung Diseases, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nebulized lidocaineProcedure or surgery
Subjects in group A underwent nebulization with 5 mL of 2% lidocaine for 15 minutes by using a jet nebulizer.
Lidocaine sprayProcedure or surgery
Subjects in group B will underwent 10% lidocaine spray solution will be sprayed 10 times at the oropharynx at 5 s interval.
Combination of nebulized lidocaine and lidocaine sprayProcedure or surgery
Group C: both nebulization and spray will be performed in the same manner except the number of spray will be 2 instead 10.
| Study group | Role | What they receive |
|---|---|---|
| Nebulized lidocaine | Experimental | Subjects in group A underwent nebulization with 5 mL of 2% lidocaine for 15 minutes by using a jet nebulizer. Receives: Procedure: Nebulized lidocaine |
| Lidocaine spray | Experimental | In group B will underwent 10% lidocaine spray solution will be sprayed 10 times at the oropharynx at 5 s interval. Receives: Procedure: Lidocaine spray |
| Combination( Nebulized lidocaine and lidocaine spray) | Experimental | Group C: both nebulization and spray will be performed in the same manner except the number of spray will be 2 instead 10. Receives: Procedure: Combination of nebulized lidocaine and lidocaine spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
The severity of cough using cough severity index
Assess the severity of cough during and within 4 hours after the procedure as (0 : absent cough is better ) , ( 5 : disturbing cough is the worst )
Measured: During and within 3 hours after procedure
pain during the procedure rated by the subjects on the Faces Pain Rating Scale.
As (0 : no pain , the best) , ( 10 : worst pain )
Measured: During and within 3 hours after procedure
time taken to cross the vocal cords.
the median time in seconds will be calculated during the procedure from the introduction the tip of bronchoscope from the nostril to second at which the tip of bronchoscopy cross the the vocal cords.
Measured: at the beginning of the procedure(time zero) till seconds after crossing the vocal cords
changes in heart rate
changes in the heart rate from the baseline before procedure
Measured: During and within 3 hours after procedure
Changes in oxygen saturation
changes in the oxygen saturation from the baseline before procedure
Measured: During and within 3 hours after procedure
Secondary outcomes (3)
cumulative dose of lidocaine administered during the procedure.
Less cumulative dose of lidocaine needed during the procedure is better
Measured: During the procedure
adverse reactions to lidocaine
assess for any adverse effects related to lidocaine use especially arrhythmia or other adverse effects as convulsions, involuntary movements, bronchospasm, and anaphylaxis.
Measured: During and within 3 hours after procedure
overall satisfaction with the procedure using likert scale .
As (1 : strongly disagree , is the worst) and (5 : strongly agree , is better)
Measured: During and within 3 hours after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2024
- Study startSep 2024 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lidocaine SprayStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects in group A underwent nebulization with 5 mL of 2% lidocaine for 15 minutes by using a jet nebulizer. In group B will underwent 10% lidocaine spray solution will be sprayed 10 times at the oropharynx at 5 s interval. Group C: both nebulization and spray will be performed in the same manner except the number of spray will be 2 instead 10.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bassem Gadallah Gad-Elkariem Kalam, Assiut University
- Investigators
- Mohamed Mostafa Abdelhadi, Study director, Professor of Chest Diseases and TuberculosisMontaser Gamal Ahmed, Study director, lecturer of Chest Diseases and TuberculosisNermeen Mohammed Abuelkassem, Study director, lecturer of Chest Diseases and Tuberculosis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06563050
- Sponsor's protocol ID
- Lidocaine use during FB
- Status last verified
- Aug 2024
- First submitted
- 5 Aug 2024
- Last updated
- 22 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Nebulized Lidocaine, Lidocaine Spray, or Their Combination for Topical Anesthesia During Diagnostic Flexible Bronchoscopy: a Randomized Trial
- ClinicalTrials.gov ID
- NCT06563050
- Acronym / sponsor ID
- Lidocaine use during FB
- Conditions
- Lidocaine Spray, Nebulized Lidocaine, Lung Diseases, Lung Cancer
- Keywords
- flexible bronchoscopy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Sep 2024 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 20 Aug 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.
compare the efficacy and safety of nebulized lidocaine, oropharyngeal lidocaine spray, or their combination for better outcome of topical anesthesia in subjects undergoing diagnostic FB; severity of cough , pain during procedure , cumulative dose of anesthesia needed and its adverse reaction , overall satisfaction .
Detailed description
Flexible bronchoscopy (FB) is a commonly performed procedure in the diagnosis and treatment of several respiratory disease. Although FB is generally a short procedure, it is uncomfortable for the patient. At least the use of topical anesthesia during FB is essential, especially when performed without sedation. Effective topical anesthesia blunts airway reflexes such as gag, cough, and laryngospasm.
The reduction in cough not only improves patient comfort but also makes the procedure easier for the operator.
Among agents used for topical anesthesia, lidocaine is the most widely used drug because of its safety and favorable pharmacokinetic profile.
Lidocaine is available in various formulations (gel or solution) and can be delivered to the respiratory passages by using different modes (spray, nebulization, transtracheal injection, bronchoscope instillation, and others).
In this study, will compare the efficacy and safety of nebulized lidocaine, oropharyngeal lidocaine spray, or their combination for topical anesthesia in subjects undergoing diagnostic FB, for better outcome.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Subjects in group A underwent nebulization with 5 mL of 2% lidocaine for 15 minutes by using a jet nebulizer. In group B will underwent 10% lidocaine spray solution will be sprayed 10 times at the oropharynx at 5 s interval. Group C: both nebulization and spray will be performed in the same manner except the number of spray will be 2 instead 10.
| Arm | Type | Receives |
|---|---|---|
| Nebulized lidocaine | Experimental | Procedure: Nebulized lidocaineSubjects in group A underwent nebulization with 5 mL of 2% lidocaine for 15 minutes by using a jet nebulizer. |
| Lidocaine spray | Experimental | Procedure: Lidocaine sprayIn group B will underwent 10% lidocaine spray solution will be sprayed 10 times at the oropharynx at 5 s interval. |
| Combination( Nebulized lidocaine and lidocaine spray) | Experimental | Procedure: Combination of nebulized lidocaine and lidocaine sprayGroup C: both nebulization and spray will be performed in the same manner except the number of spray will be 2 instead 10. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients above 18 years old will undergo FB are included in this study.
Key exclusion criteria (4 listed)
- known hypersensitivity to lidocaine.
- Pregnancy.
- hemodynamic instability.
- failure to provide informed consent.
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 |
|---|---|---|
| Nebulized lidocaineSubjects in group A underwent nebulization with 5 mL of 2% lidocaine for 15 minutes by using a jet nebulizer. | Procedure or surgery | Nebulized lidocaine |
| Lidocaine spraySubjects in group B will underwent 10% lidocaine spray solution will be sprayed 10 times at the oropharynx at 5 s interval. | Procedure or surgery | Lidocaine spray |
| Combination of nebulized lidocaine and lidocaine sprayGroup C: both nebulization and spray will be performed in the same manner except the number of spray will be 2 instead 10. | Procedure or surgery | Combination( Nebulized lidocaine and lidocaine spray) |
Primary outcome
The severity of cough using cough severity index
Time frame: During and within 3 hours after procedure
Assess the severity of cough during and within 4 hours after the procedure as (0 : absent cough is better ) , ( 5 : disturbing cough is the worst )
pain during the procedure rated by the subjects on the Faces Pain Rating Scale.
Time frame: During and within 3 hours after procedure
As (0 : no pain , the best) , ( 10 : worst pain )
time taken to cross the vocal cords.
Time frame: at the beginning of the procedure(time zero) till seconds after crossing the vocal cords
the median time in seconds will be calculated during the procedure from the introduction the tip of bronchoscope from the nostril to second at which the tip of bronchoscopy cross the the vocal cords.
changes in heart rate
Time frame: During and within 3 hours after procedure
changes in the heart rate from the baseline before procedure
Changes in oxygen saturation
Time frame: During and within 3 hours after procedure
changes in the oxygen saturation from the baseline before procedure
3 secondary outcomes
cumulative dose of lidocaine administered during the procedure.
Time frame: During the procedure
adverse reactions to lidocaine
Time frame: During and within 3 hours after procedure
overall satisfaction with the procedure using likert scale .
Time frame: During and within 3 hours after procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2024.
- Individual participant dataSharing planned: Yes
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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.
Mohamed Mostafa Abdelhadi study director
Professor of Chest Diseases and Tuberculosis
Montaser Gamal Ahmed study director
lecturer of Chest Diseases and Tuberculosis
Nermeen Mohammed Abuelkassem study director
lecturer of Chest Diseases and Tuberculosis
Questions about this trial
What is this clinical trial studying?
A study testing Nebulized lidocaine, Lidocaine spray and Combination of nebulized lidocaine and lidocaine spray in people with Lidocaine Spray and Nebulized Lidocaine, run by Assiut University.
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 1 inclusion and 4 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: opening soon, as of the sponsor's last update on 22 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bassem Gadallah Gad-Elkariem Kalam (01210414954, basam.16266060@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The severity of cough using cough severity index (time frame: During and within 3 hours after procedure). The study lists 5 primary outcomes in all. 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 22 Aug 2024.