Clinical trial NCT03829618: Lidocaine Administration During Flexible Bronchoscopy and Endobronchial Ultrasound
Official title: Lidocaine Administration During Flexible Bronchoscopy and Endobronchial Ultrasound
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Bronchiectasis Adult
Mediastinal Lymphadenopathy
Pneumonia
Chest--Diseases
Infiltrates
Bronchopulmonary Disease
Cancer, Lung
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2019-02-04
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Cough
timeFrame: 1 day
Secondary outcomes:
measure: Number of Participants With Post-procedure Sore Throat
timeFrame: 1 day
measure: Number of Participants With Post-Procedure Subjective Cough
timeFrame: 1 day
measure: Anesthesia Time to Wake up
timeFrame: 1 day
measure: Alfentanyl Dosing
timeFrame: 1 day
measure: Propofol Dosing
timeFrame: 1 day
measure: Fentanyl Dosing
timeFrame: 1 day
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Penn State Hershey Medical Center
state: Pennsylvania
Study officials:
affiliation: Milton S. Hershey Medical Center
name: Jennifer Toth
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.