Comparison Between Different Ways for Using Lidocaine During FB
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAssiut University
About this 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 .
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients above 18 years old will undergo FB are included in this study.
Disqualifiers
known hypersensitivity to lidocaine.
Pregnancy.
hemodynamic instability.
failure to provide informed consent.
Trial design
Design model
Parallel
Treatments tested in this trial
Nebulized lidocaine
Procedure/SurgerySubjects in group A underwent nebulization with 5 mL of 2% lidocaine for 15 minutes by using a jet nebulizer.
Lidocaine spray
Procedure/SurgerySubjects 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 spray
Procedure/SurgeryGroup C: both nebulization and spray will be performed in the same manner except the number of spray will be 2 instead 10.
Treatment groups
240 Participants
are divided into 3 treatment groupsGroup A: Nebulized lidocaineExperimental treatment 1 intervention
Group B: Lidocaine sprayExperimental treatment 1 intervention
Group C: Combination( Nebulized lidocaine and lidocaine spray)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 procedure2
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 procedure3
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 cords4
changes in heart rate
changes in the heart rate from the baseline before procedure
Time frame
During and within 3 hours after procedureSecondary outcomes
1
cumulative dose of lidocaine administered during the procedure.
Less cumulative dose of lidocaine needed during the procedure is better
Time frame
During the procedure2
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 procedure3
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 procedureLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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