Comparison Between Different Ways for Using Lidocaine During FB

NCT06563050 | Not Yet Recruiting

• 1 other identifier: Lidocaine use during FB
• Study Type: interventional
• Target: 240
• Locations: 0 countries
• Sites: N/A

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 .

Conditions

Lidocaine Spray; Nebulized Lidocaine; Lung Diseases; Lung Cancer

Keywords

flexible bronchoscopy

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (3)

• cumulative dose of lidocaine administered during the procedure.

  During the procedure

• adverse reactions to lidocaine

  During and within 3 hours after procedure

• overall satisfaction with the procedure using likert scale .

  During and within 3 hours after procedure

Study Arms (3)

Nebulized lidocaine

EXPERIMENTAL

Subjects in group A underwent nebulization with 5 mL of 2% lidocaine for 15 minutes by using a jet nebulizer.

Procedure: Nebulized lidocaine

Lidocaine spray

EXPERIMENTAL

In group B will underwent 10% lidocaine spray solution will be sprayed 10 times at the oropharynx at 5 s interval.

Procedure: Lidocaine spray

Combination( Nebulized lidocaine and lidocaine spray)

EXPERIMENTAL

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

Interventions

Nebulized lidocaine PROCEDURE

Subjects in group A underwent nebulization with 5 mL of 2% lidocaine for 15 minutes by using a jet nebulizer.

Nebulized lidocaine

Lidocaine spray PROCEDURE

Subjects in group B will underwent 10% lidocaine spray solution will be sprayed 10 times at the oropharynx at 5 s interval.

Lidocaine spray

Combination of nebulized lidocaine and lidocaine spray PROCEDURE

Group C: both nebulization and spray will be performed in the same manner except the number of spray will be 2 instead 10.

Combination( Nebulized lidocaine and lidocaine spray)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients above 18 years old will undergo FB are included in this study.

You may not qualify if:

• known hypersensitivity to lidocaine.
• Pregnancy.
• hemodynamic instability.
• failure to provide informed consent.

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Lung Diseases; Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms

Study Officials

• 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 DIRECTOR

Central Study Contacts

Bassem Gadallah Gad-Elkariem Kalam

CONTACT

01210414954; basam.16266060@med.aun.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The study subjects will not be blinded; the bronchoscopist and the assessor of outcomes will be blinded to the group allocation.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident doctor at Chest Diseases Department

Model Details: 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.

Study Record Dates

• First Submitted: August 5, 2024
• First Posted: August 20, 2024
• Study Start: September 1, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: August 22, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share