Lidocaine Spray, Nebulized Lidocaine, Lung Diseases, Lung Cancer
Conditions
Keywords
flexible bronchoscopy
Brief 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 .
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.
Interventions
PROCEDURENebulized lidocaine
Subjects in group A underwent nebulization with 5 mL of 2% lidocaine for 15 minutes by using a jet nebulizer.
PROCEDURELidocaine spray
Subjects in group B will underwent 10% lidocaine spray solution will be sprayed 10 times at the oropharynx at 5 s interval.
PROCEDURECombination of nebulized lidocaine and 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.
Sponsors
Assiut University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
The study subjects will not be blinded; the bronchoscopist and the assessor of outcomes will be blinded to the group allocation.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients above 18 years old will undergo FB are included in this study.
Exclusion criteria
* known hypersensitivity to lidocaine. * Pregnancy. * hemodynamic instability. * failure to provide informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in oxygen saturation | During and within 3 hours after procedure | changes in the oxygen saturation from the baseline before procedure |
| pain during the procedure rated by the subjects on the Faces Pain Rating Scale. | During and within 3 hours after procedure | As (0 : no pain , the best) , ( 10 : worst pain ) |
| time taken to cross the vocal cords. | 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 | During and within 3 hours after procedure | changes in the heart rate from the baseline before procedure |
| The severity of cough using cough severity index | 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 ) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| adverse reactions to lidocaine | During and within 3 hours after procedure | assess for any adverse effects related to lidocaine use especially arrhythmia or other adverse effects as convulsions, involuntary movements, bronchospasm, and anaphylaxis. |
| overall satisfaction with the procedure using likert scale . | During and within 3 hours after procedure | As (1 : strongly disagree , is the worst) and (5 : strongly agree , is better) |
| cumulative dose of lidocaine administered during the procedure. | During the procedure | Less cumulative dose of lidocaine needed during the procedure is better |
Contacts
Primary ContactBassem Gadallah Gad-Elkariem Kalam
Outcome results
None listed