Comparison Between Different Ways for Using Lidocaine During FB

Comparison Between Nebulized Lidocaine, Lidocaine Spray, or Their Combination for Topical Anesthesia During Diagnostic Flexible Bronchoscopy: a Randomized 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 .

Study Overview

• Status: Not yet recruiting
• Conditions: Lung Diseases; Lung Cancer; Lidocaine Spray; Nebulized Lidocaine
• Intervention / Treatment: Procedure: Nebulized lidocaine; Procedure: Lidocaine spray; Procedure: Combination of nebulized lidocaine and lidocaine spray

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 Type: Interventional
• Enrollment (Estimated): 240
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bassem Gadallah Gad-Elkariem Kalam; Phone Number: 01210414954; Email: basam.16266060@med.aun.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nebulized lidocaine; Subjects in group A underwent nebulization with 5 mL of 2% lidocaine for 15 minutes by using a jet nebulizer.	Procedure: Nebulized lidocaine; Subjects in group A underwent nebulization with 5 mL of 2% lidocaine for 15 minutes by using a jet nebulizer.
Experimental: Lidocaine spray; In group B will underwent 10% lidocaine spray solution will be sprayed 10 times at the oropharynx at 5 s interval.	Procedure: Lidocaine spray; Subjects in group B will underwent 10% lidocaine spray solution will be sprayed 10 times at the oropharynx at 5 s interval.
Experimental: Combination( 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.	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 )	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 )	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.	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	During and within 3 hours after procedure
Changes in oxygen saturation	changes in the oxygen saturation from the baseline before procedure	During and within 3 hours after procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cumulative dose of lidocaine administered during the procedure.	Less cumulative dose of lidocaine needed during the procedure is better	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.	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)	During and within 3 hours after procedure

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Study Director: Mohamed Mostafa Abdelhadi, Professor of Chest Diseases and Tuberculosis; Study Director: Montaser Gamal Ahmed, lecturer of Chest Diseases and Tuberculosis; Study Director: Nermeen Mohammed Abuelkassem, lecturer of Chest Diseases and Tuberculosis

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: August 5, 2024
• First Submitted That Met QC Criteria: August 17, 2024
• First Posted (Actual): August 20, 2024

Study Record Updates

• Last Update Posted (Actual): August 22, 2024
• Last Update Submitted That Met QC Criteria: August 20, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: flexible bronchoscopy
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: Lidocaine use during FB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No