Lidocaine Administration During Flexible Bronchoscopy and Endobronchial Ultrasound

Phase 3

Terminated

• Conditions: Bronchopulmonary Disease; Bronchiectasis Adult; Mediastinal Lymphadenopathy; Pneumonia; Infiltrates; Chest--Diseases; Cancer, Lung
• Interventions: Drug: Nebuliser solution; Drug: Nebuliser Suspension; Drug: Topical lidocaine

• Registration Number: NCT03829618
• Lead Sponsor: Milton S. Hershey Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-01-24
• Study First Submitted QC: 2019-02-01
• Study First Posted: 2019-02-04
• Study Start: 2019-04-01
• Primary Completion: 2020-08-31
• Study Completion: 2020-08-31
• Status Verified: 2021-09
• Results First Submitted: 2021-09-08
• Results First Submitted QC: 2021-10-08
• Last Update Submitted: 2021-10-08
• Results First Posted: 2021-10-12
• Last Update Posted: 2021-10-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 29

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nebuliser Solution	Nebuliser solution	2% lidocaine dosed at 2mg/kg with max dose of 160mg nebulized via jet nebulizer in operating room over ten minutes.
Nebuliser Suspension	Nebuliser Suspension	2% lidocaine dosed at 2mg/kg with max dose of 160mg nebulized via vibrating mesh nebulizer in operating room over ten minutes.
Topical Lidocaine	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.

Primary Outcome Measures

Name	Time	Method
Cough	1 day	Number of coughs during procedure as defined by cough requiring stopping procedure or treatment by anesthesiologist with propofol or alfentanyl

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Penn State Hershey Medical Center; 🇺🇸 Hershey, Pennsylvania, United States