Clinical trial NCT06563050: Comparison Between Different Ways for Using Lidocaine During FB
Official title: Comparison Between Nebulized Lidocaine, Lidocaine Spray, or Their Combination for Topical Anesthesia During Diagnostic Flexible Bronchoscopy: a Randomized Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Lidocaine Spray
Nebulized Lidocaine
Lung Diseases
Lung Cancer
Keywords: flexible bronchoscopy
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-08-20
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The severity of cough using cough severity index
timeFrame: During and within 3 hours after procedure
measure: pain during the procedure rated by the subjects on the Faces Pain Rating Scale.
timeFrame: During and within 3 hours after procedure
measure: time taken to cross the vocal cords.
timeFrame: at the beginning of the procedure(time zero) till seconds after crossing the vocal cords
measure: changes in heart rate
timeFrame: During and within 3 hours after procedure
measure: Changes in oxygen saturation
timeFrame: During and within 3 hours after procedure
Secondary outcomes:
measure: cumulative dose of lidocaine administered during the procedure.
timeFrame: During the procedure
measure: adverse reactions to lidocaine
timeFrame: During and within 3 hours after procedure
measure: overall satisfaction with the procedure using likert scale .
timeFrame: During and within 3 hours after procedure
Other outcomes:
Locations:
Study officials:
affiliation: Professor of Chest Diseases and Tuberculosis
name: Mohamed Mostafa Abdelhadi
role: STUDY_DIRECTOR
affiliation: lecturer of Chest Diseases and Tuberculosis
name: Montaser Gamal Ahmed
role: STUDY_DIRECTOR
affiliation: lecturer of Chest Diseases and Tuberculosis
name: Nermeen Mohammed Abuelkassem
role: STUDY_DIRECTOR
References: