An interventional study of Nebulized lidocaine and Lidocaine spray in Lidocaine Spray, Nebulized Lidocaine and Lung Diseases, sponsored by Assiut University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-22.
Sponsored by Assiut University · Not applicable, Interventional, and Supportive care
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 .
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.
3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.
This study's planned enrollment of 240 is above the median of 72 across 2,118 interventional studies indexed under Lung Diseases.
Browse Lung Diseases studies →Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Subjects in group A underwent nebulization with 5 mL of 2% lidocaine for 15 minutes by using a jet nebulizer.
Procedure: Nebulized lidocaine
In group B will underwent 10% lidocaine spray solution will be sprayed 10 times at the oropharynx at 5 s interval.
Procedure: Lidocaine spray
Group C: both nebulization and spray will be performed in the same manner except the number of spray will be 2 instead 10.
Procedure: Combination of nebulized lidocaine and lidocaine spray
Subjects in group A underwent nebulization with 5 mL of 2% lidocaine for 15 minutes by using a jet nebulizer.
Subjects 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.
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 )
Time frame: 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 )
Time frame: 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.
Time frame: 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
Time frame: During and within 3 hours after procedure
Changes in oxygen saturation
changes in the oxygen saturation from the baseline before procedure
Time frame: During and within 3 hours after procedure
cumulative dose of lidocaine administered during the procedure.
Less cumulative dose of lidocaine needed during the procedure is better
Time frame: 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.
Time frame: 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)
Time frame: During and within 3 hours after procedure
No study locations are listed for this record.
Plan to share: Yes
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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Assiut University