Comparison Between Different Ways for Using Lidocaine During FB

Not Applicable

Not yet recruiting

• Conditions: Lidocaine Spray; Nebulized Lidocaine; Lung Diseases; Lung Cancer
• Interventions: Procedure: Combination of nebulized lidocaine and lidocaine spray; Procedure: Nebulized lidocaine; Procedure: Lidocaine spray

• Registration Number: NCT06563050
• Lead Sponsor: Assiut University

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.

Study Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-08-05
• Study First Submitted QC: 2024-08-17
• Study First Posted: 2024-08-20
• Last Update Submitted: 2024-08-20
• Last Update Posted: 2024-08-22
• Study Start: 2024-09
• Primary Completion: 2026-09
• Study Completion: 2026-11

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 240

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Combination( Nebulized lidocaine and lidocaine spray)	Combination 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.
Nebulized lidocaine	Nebulized lidocaine	Subjects in group A underwent nebulization with 5 mL of 2% lidocaine for 15 minutes by using a jet nebulizer.
Lidocaine spray	Lidocaine spray	In group B will underwent 10% lidocaine spray solution will be sprayed 10 times at the oropharynx at 5 s interval.

Primary Outcome Measures

Name	Time	Method
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 oxygen saturation	During and within 3 hours after procedure	changes in the oxygen saturation 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 )
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 )
changes in heart rate	During and within 3 hours after procedure	changes in the heart rate from the baseline before procedure

Secondary Outcome Measures

Name	Time	Method
cumulative dose of lidocaine administered during the procedure.	During the procedure	Less cumulative dose of lidocaine needed during the procedure is better
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)