Menu
Not yet recruiting NCT06563050

Comparison Between Different Ways for Using Lidocaine During FB

No phase Interventional Lidocaine Spray Nebulized Lidocaine Lung Diseases Lung Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Nebulized lidocaine, Lidocaine spray, Combination of nebulized lidocaine and lidocaine spray.
Who it may be relevant to
Registry conditions: Lidocaine Spray, Nebulized Lidocaine, Lung Diseases, Lung Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • The severity of cough using cough severity index [Time frame: During and within 3 hours after procedure]
  • pain during the procedure rated by the subjects on the Faces Pain Rating Scale. [Time frame: During and within 3 hours after procedure]
  • time taken to cross the vocal cords. [Time frame: at the beginning of the procedure(time zero) till seconds after crossing the vocal cords]
  • changes in heart rate [Time frame: During and within 3 hours after procedure]
  • Changes in oxygen saturation [Time frame: During and within 3 hours after procedure]
Secondary outcome measures (3)
  • cumulative dose of lidocaine administered during the procedure. [Time frame: During the procedure]
  • adverse reactions to lidocaine [Time frame: During and within 3 hours after procedure]
  • overall satisfaction with the procedure using likert scale . [Time frame: During and within 3 hours after procedure]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Supportive care

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06563050 · Lidocaine use during FB

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗