Lidocaine Administration During Flexible Bronchoscopy and Endobronchial Ultrasound

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-01

Study Completion Date

2020-08-31

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.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Topical Lidocaine

16 ml of 1% lidocaine sprayed in 4 ml aliquots to vocal cords, midtrachea, left main stem bronchus and right main stem bronchus.

Group Type ACTIVE_COMPARATOR

Topical lidocaine

Intervention Type DRUG

1% lidocaine topically applied in 4 mL aliquots

Nebuliser Solution

2% lidocaine dosed at 2mg/kg with max dose of 160mg nebulized via jet nebulizer in operating room over ten minutes.

Group Type ACTIVE_COMPARATOR

Nebuliser solution

Intervention Type DRUG

2% lidocaine dose at 2 mg/kg (max 160 mg) applied via jet nebulizer

Nebuliser Suspension

2% lidocaine dosed at 2mg/kg with max dose of 160mg nebulized via vibrating mesh nebulizer in operating room over ten minutes.

Group Type ACTIVE_COMPARATOR

Nebuliser Suspension

Intervention Type DRUG

2% lidocaine dosed at 2 mg/kg (max 160 mg) applied via vibrating mesh nebulizer

Interventions

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Topical lidocaine

1% lidocaine topically applied in 4 mL aliquots

Intervention Type DRUG

Nebuliser solution

2% lidocaine dose at 2 mg/kg (max 160 mg) applied via jet nebulizer

Intervention Type DRUG

Nebuliser Suspension

2% lidocaine dosed at 2 mg/kg (max 160 mg) applied via vibrating mesh nebulizer

Intervention Type DRUG

Other Intervention Names

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Topical Nebulizer Atomizer

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes