Lidocaine Administration During Flexible Bronchoscopy and Endobronchial Ultrasound

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17036
      • Penn State Hershey Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Drug: Topical lidocaine; 1% lidocaine topically applied in 4 mL aliquots; Other Names: Topical
Active Comparator: Nebuliser Solution; 2% lidocaine dosed at 2mg/kg with max dose of 160mg nebulized via jet nebulizer in operating room over ten minutes.	Drug: Nebuliser solution; 2% lidocaine dose at 2 mg/kg (max 160 mg) applied via jet nebulizer; Other Names: Nebulizer
Active Comparator: Nebuliser Suspension; 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; 2% lidocaine dosed at 2 mg/kg (max 160 mg) applied via vibrating mesh nebulizer; Other Names: Atomizer

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Milton S. Hershey Medical Center
• Investigators: Principal Investigator: Jennifer Toth, Milton S. Hershey Medical Center

Publications and helpful links

General Publications

• Wahidi MM, Jain P, Jantz M, Lee P, Mackensen GB, Barbour SY, Lamb C, Silvestri GA. American College of Chest Physicians consensus statement on the use of topical anesthesia, analgesia, and sedation during flexible bronchoscopy in adult patients. Chest. 2011 Nov;140(5):1342-1350. doi: 10.1378/chest.10-3361.
• Stolz D, Chhajed PN, Leuppi J, Pflimlin E, Tamm M. Nebulized lidocaine for flexible bronchoscopy: a randomized, double-blind, placebo-controlled trial. Chest. 2005 Sep;128(3):1756-60. doi: 10.1378/chest.128.3.1756.
• Madan K, Biswal SK, Mittal S, Hadda V, Mohan A, Khilnani GC, Pandey RM, Guleria R. 1% Versus 2% Lignocaine for Airway Anesthesia in Flexible Bronchoscopy Without Lignocaine Nebulization (LIFE): A Randomized Controlled Trial. J Bronchology Interv Pulmonol. 2018 Apr;25(2):103-110. doi: 10.1097/LBR.0000000000000458.
• Dreher M, Cornelissen CG, Reddemann MA, Muller A, Hubel C, Muller T. Nebulized versus Standard Local Application of Lidocaine during Flexible Bronchoscopy: A Randomized Controlled Trial. Respiration. 2016;92(4):266-273. doi: 10.1159/000449135. Epub 2016 Sep 10.
• Amini S, Peiman S, Khatuni M, Ghalamkari M, Rahimi B. The Effect of Dextromethorphan Premedication on Cough and Patient Tolerance During Flexible Bronchoscopy: A Randomized, Double-blind, Placebo-controlled Trial. J Bronchology Interv Pulmonol. 2017 Oct;24(4):263-267. doi: 10.1097/LBR.0000000000000385.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2019
• Primary Completion (Actual): August 31, 2020
• Study Completion (Actual): August 31, 2020

Study Registration Dates

• First Submitted: January 24, 2019
• First Submitted That Met QC Criteria: February 1, 2019
• First Posted (Actual): February 4, 2019

Study Record Updates

• Last Update Posted (Actual): October 12, 2021
• Last Update Submitted That Met QC Criteria: October 8, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lymphatic Diseases; Lung Diseases; Neoplasms by Site; Bronchial Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Bronchiectasis; Lung Neoplasms; Lymphadenopathy; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: STUDY00009727

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes