Study Stopped
COVID lack of cases/recruitment
Lidocaine Administration During Flexible Bronchoscopy and Endobronchial Ultrasound
1 other identifier
interventional
29
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Apr 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 24, 2019
CompletedFirst Posted
Study publicly available on registry
February 4, 2019
CompletedStudy Start
First participant enrolled
April 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2020
CompletedResults Posted
Study results publicly available
October 12, 2021
CompletedOctober 12, 2021
September 1, 2021
1.4 years
January 24, 2019
September 8, 2021
October 8, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Cough
Number of coughs during procedure as defined by cough requiring stopping procedure or treatment by anesthesiologist with propofol or alfentanyl
1 day
Secondary Outcomes (6)
Number of Participants With Post-procedure Sore Throat
1 day
Number of Participants With Post-Procedure Subjective Cough
1 day
Anesthesia Time to Wake up
1 day
Alfentanyl Dosing
1 day
Propofol Dosing
1 day
- +1 more secondary outcomes
Study Arms (3)
Topical Lidocaine
ACTIVE COMPARATOR16 ml of 1% lidocaine sprayed in 4 ml aliquots to vocal cords, midtrachea, left main stem bronchus and right main stem bronchus.
Nebuliser Solution
ACTIVE COMPARATOR2% lidocaine dosed at 2mg/kg with max dose of 160mg nebulized via jet nebulizer in operating room over ten minutes.
Nebuliser Suspension
ACTIVE COMPARATOR2% lidocaine dosed at 2mg/kg with max dose of 160mg nebulized via vibrating mesh nebulizer in operating room over ten minutes.
Interventions
1% lidocaine topically applied in 4 mL aliquots
2% lidocaine dose at 2 mg/kg (max 160 mg) applied via jet nebulizer
2% lidocaine dosed at 2 mg/kg (max 160 mg) applied via vibrating mesh nebulizer
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Penn State Hershey Medical Center
Hershey, Pennsylvania, 17036, United States
Related Publications (5)
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.
PMID: 29346249BACKGROUNDStolz 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.
PMID: 16162784BACKGROUNDWahidi 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.
PMID: 22045879BACKGROUNDDreher 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.
PMID: 27614989BACKGROUNDAmini 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.
PMID: 28891835RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
The target enrollment was not reached secondary to the COVID-19 pandemic.
Results Point of Contact
- Title
- Zoulfira Nisnevitch-Savarese, M.D.
- Organization
- Penn State Hershey Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Jennifer Toth
Milton S. Hershey Medical Center
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Medicine and Surgery, Director of Interventional Pulmonology
Study Record Dates
First Submitted
January 24, 2019
First Posted
February 4, 2019
Study Start
April 1, 2019
Primary Completion
August 31, 2020
Study Completion
August 31, 2020
Last Updated
October 12, 2021
Results First Posted
October 12, 2021
Record last verified: 2021-09
Data Sharing
- IPD Sharing
- Will not share