Lidocaine Administration During Flexible Bronchoscopy and Endobronchial Ultrasound

Study Overview
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Brief Summary
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The purpose of this study is to assess if there is decrease in cough during flexible bronchoscopy and endobronchial ultrasound when different modes of lidocaine administration are used. The modes of administration being evaluated are topical, nebulized and atomized.

Official Title
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Lidocaine Administration During Flexible Bronchoscopy and Endobronchial Ultrasound

Conditions
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Pneumonia, Bronchiectasis Adult, Mediastinal Lymphadenopathy, Chest--Diseases, Infiltrates, Bronchopulmonary Disease, Cancer, Lung

Intervention / Treatment
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* Drug: Topical lidocaine
* Drug: Nebuliser solution
* Drug: Nebuliser Suspension


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of mediastinal and/or hilar lymphadenopathy requiring endobronchial ultrasound evaluation and transbronchial needle aspiration. Diagnosis of pulmonary disease requiring flexible bronchoscopy Greater than 18 years of age. Exclusion Criteria: Any intervention beyond flexible bronchoscopy and endobronchial ultrasound Inability to tolerate bronchoscopy. Patients that receive paralytics. Patients with neuromuscular diseases. Inability to consent for procedures. Allergies to lidocaine or any other drugs used in protocol. Existing renal insufficiency or liver disease

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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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Topical Lidocaine<br>16 ml of 1% lidocaine sprayed in 4 ml aliquots to vocal cords, midtrachea, left main stem bronchus and right main stem bronchus. | Drug: Topical lidocaine<br>* 1% lidocaine topically applied in 4 mL aliquots<br>* Other names: Topical;|
| Active Comparator: Nebuliser Solution<br>2% lidocaine dosed at 2mg/kg with max dose of 160mg nebulized via jet nebulizer in operating room over ten minutes. | Drug: Nebuliser solution<br>* 2% lidocaine dose at 2 mg/kg (max 160 mg) applied via jet nebulizer<br>* Other names: Nebulizer;|
| Active Comparator: Nebuliser Suspension<br>2% lidocaine dosed at 2mg/kg with max dose of 160mg nebulized via vibrating mesh nebulizer in operating room over ten minutes. | Drug: Nebuliser Suspension<br>* 2% lidocaine dosed at 2 mg/kg (max 160 mg) applied via vibrating mesh nebulizer<br>* Other names: Atomizer;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cough | Number of coughs during procedure as defined by cough requiring stopping procedure or treatment by anesthesiologist with propofol or alfentanyl | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Post-procedure Sore Throat | sore throat was self reported by patient as: none, mild, moderate, severe | 1 day | 
| Number of Participants With Post-Procedure Subjective Cough | Subjective cough as described by patient as: none, mild, moderate, severe | 1 day | 
| Anesthesia Time to Wake up | time in minutes from scope out until ready for transport to post anesthesia care unit | 1 day | 
| Alfentanyl Dosing | Total alfentanyl dosing by anesthesia in mcg/kg | 1 day | 
| Propofol Dosing | Total propofol dosing by anesthesia in mg/kg | 1 day | 
| Fentanyl Dosing | total fentanyl dosing by anesthesia in mcg/kg | 1 day |