Nebulized Lignocaine for Topical Airway Anesthesia During Flexible Bronchoscopy: A Randomized Controlled Trial

Study Overview
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Brief Summary
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Flexible bronchoscopy is one of the most widely performed procedures for diagnosis of various bronchopulmonary diseases. Most patients tolerate the procedure well although cough is often reported as a distressing symptom. It is likely that the acceptance of bronchoscopy would be significantly improved with control of cough. Use of sedation during bronchoscopy has been reported to improve procedure tolerance. However, awake(no sedation) bronchoscopy is routinely performed at many centres including ours. Topical lignocaine is administered during bronchoscopy for local anaesthesia. There is limited literature on the efficacy of lignocaine delivered with the nebulized route during awake flexible bronchoscopy. This study would help to determine the utility of nebulized lignocaine in airway anaesthesia during flexible bronchoscopy.

Detailed Description
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For all patients meeting the inclusion criteria, the demographic profile including age, sex, weight, smoking history and the type of procedures performed during bronchoscopy shall be recorded. A written informed consent will be obtained from all participants. The patients who undergo flexible bronchoscopy would be randomised in a one is to one ratio either to nebulized lignocaine (4%) or saline (placebo) nebulization group. Prior to the bronchoscopy blood pressure, pulse rate, respiratory rate and pulse oximetry saturation will be recorded at the baseline Patients in both the groups shall be prepared in a similar fashion except for the nebulized lignocaine. Patient, Operator, outcome assessor will be blinded to the allocation. During the procedure, 1.5ml aliquots of 1% lignocaine will be delivered through the bronchoscope using spray-as-you go technique. The patients would be monitored for any adverse effects throughout the procedure. The bronchoscopist doing the procedure will be provided 2 VAS charts to mark the severity of cough and overall procedure satisfaction. Post procedure, patients will record the pain experienced while undergoing the procedure on the faces pain rating scale.

Official Title
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Nebulized Lignocaine for Topical Airway Anesthesia During Flexible Bronchoscopy: A Randomized Controlled Trial

Conditions
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Bronchopulmonary Disease

Intervention / Treatment
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* Drug: Lignocaine Nebulization
* Drug: Saline Nebulization


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult (Age > 18 years) patients undergoing diagnostic or therapeutic flexible bronchoscopy Exclusion Criteria: Pregnancy Hypoxemia (oxygen saturation [by pulse oximetry] < 92% with Fio2 of ≥ 0.3 Bronchoscopy done through endotracheal or tracheostomy tube Not willing to provide informed consent. Patient requiring sedation for flexible bronchoscopy Patients with known allergy to lignocaine -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nebulized Lignocaine<br>4% Lignocaine administered as nebulization for topical anaesthesia during bronchoscopy procedure | Drug: Lignocaine Nebulization<br>* 4% Lignocaine delivered via Nebulization<br>|
| Placebo Comparator: Nebulized Saline<br>Normal Saline administered as nebulization for topical anaesthesia during bronchoscopy procedure | Drug: Saline Nebulization<br>* Normal Saline Delivered via Nebulization<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operator rated overall procedure satisfaction VAS |  | At study completion approx. 12 months | 
| Operator rated cough VAS |  | At study completion approx. 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total dose of Lignocaine administered (mg) |  | At study completion approx. 12 months | 
| Number of patients receiving dose >8.2mg/Kg |  | At study completion approx. 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lignocaine