Lidocaine Administration During Flexible Bronchoscopy and Endobronchial Ultrasound

Penn State Health

Status and phase: Terminated; Phase 3

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

Treatments: Drug: Nebuliser Suspension; Drug: Nebuliser solution; Drug: Topical lidocaine

Study type: Interventional

Funder types: Other

Identifiers

NCT03829618

STUDY00009727

Details and patient eligibility

About

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.

Enrollment: 29 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

29 participants in 3 patient groups

Topical Lidocaine

Active Comparator group

Description:

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

Treatment:

Drug: Topical lidocaine

Nebuliser Solution

Active Comparator group

Description:

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

Treatment:

Drug: Nebuliser solution

Nebuliser Suspension

Active Comparator group

Description:

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

Treatment:

Drug: Nebuliser Suspension