Comparison Between Different Ways for Using Lidocaine During FB

Assiut University

Status: Not yet enrolling

Conditions: Nebulized Lidocaine; Lidocaine Spray; Lung Diseases; Lung Cancer

Treatments: Procedure: Lidocaine spray; Procedure: Nebulized lidocaine; Procedure: Combination of nebulized lidocaine and lidocaine spray

Study type: Interventional

Funder types: Other

Identifiers

NCT06563050

Lidocaine use during FB

Details and patient eligibility

About

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 .

Full 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.

Enrollment: 240 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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240 participants in 3 patient groups

Nebulized lidocaine

Experimental group

Description:

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

Treatment:

Procedure: Nebulized lidocaine

Lidocaine spray

Experimental group

Description:

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

Treatment:

Procedure: Lidocaine spray

Combination( Nebulized lidocaine and lidocaine spray)

Experimental group

Description:

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

Treatment:

Procedure: Combination of nebulized lidocaine and lidocaine spray