Comparison Between Different Ways for Using Lidocaine During FB

NCT ID: NCT06563050

Last Updated: 2024-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-30

Study Completion Date

2026-11-30

Brief Summary

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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

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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.

Conditions

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Lidocaine Spray Nebulized Lidocaine Lung Diseases Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
The study subjects will not be blinded; the bronchoscopist and the assessor of outcomes will be blinded to the group allocation.

Study Groups

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Nebulized lidocaine

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

Group Type EXPERIMENTAL

Nebulized lidocaine

Intervention Type PROCEDURE

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

Lidocaine spray

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

Group Type EXPERIMENTAL

Lidocaine spray

Intervention Type PROCEDURE

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

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.

Group Type EXPERIMENTAL

Combination of nebulized lidocaine and lidocaine spray

Intervention Type PROCEDURE

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

Interventions

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Nebulized lidocaine

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

Intervention Type 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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Bassem Gadallah Gad-Elkariem Kalam

Resident doctor at Chest Diseases Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mohamed Mostafa Abdelhadi

Role: STUDY_DIRECTOR

Professor of Chest Diseases and Tuberculosis

Montaser Gamal Ahmed

Role: STUDY_DIRECTOR

lecturer of Chest Diseases and Tuberculosis

Nermeen Mohammed Abuelkassem

Role: STUDY_DIRECTOR

lecturer of Chest Diseases and Tuberculosis

Central Contacts

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Bassem Gadallah Gad-Elkariem Kalam

Role: CONTACT

01210414954

Other Identifiers

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Lidocaine use during FB

Identifier Type: -

Identifier Source: org_study_id

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