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NCT Number: NCT06563050

Comparison Between Different Ways for Using Lidocaine During FB

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 .

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Key information

Conditions

Lidocaine Spray Lung Cancer Lung Diseases Lung Neoplasms Nebulized Lidocaine Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nebulized lidocaine

Procedure

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

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.

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.

Primary outcomes

  1. The severity of cough using cough severity index

    Time frame: During and within 3 hours after procedure

    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 )

  2. pain during the procedure rated by the subjects on the Faces Pain Rating Scale.

    Time frame: During and within 3 hours after procedure

    As (0 : no pain , the best) , ( 10 : worst pain )

  3. time taken to cross the vocal cords.

    Time frame: at the beginning of the procedure(time zero) till seconds after crossing 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.

  4. changes in heart rate

    Time frame: During and within 3 hours after procedure

    changes in the heart rate from the baseline before procedure

  5. Changes in oxygen saturation

    Time frame: During and within 3 hours after procedure

    changes in the oxygen saturation from the baseline before procedure

Secondary outcomes

  1. cumulative dose of lidocaine administered during the procedure.

    Time frame: During the procedure

    Less cumulative dose of lidocaine needed during the procedure is better

  2. adverse reactions to lidocaine

    Time frame: During and within 3 hours after procedure

    assess for any adverse effects related to lidocaine use especially arrhythmia or other adverse effects as convulsions, involuntary movements, bronchospasm, and anaphylaxis.

  3. overall satisfaction with the procedure using likert scale .

    Time frame: During and within 3 hours after procedure

    As (1 : strongly disagree , is the worst) and (5 : strongly agree , is better)

Study contacts

Contact information is provided by the study sponsor or research team.

Bassem Gadallah Gad-Elkariem Kalam

CONTACT

[email protected]

01210414954

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 20, 2024
Registry last updated
Aug 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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