Lidocaine Administration During Flexible Bronchoscopy and Endobronchial Ultrasound

Pneumonia Clinical Trial

Official title:

Lidocaine Administration During Flexible Bronchoscopy and Endobronchial Ultrasound

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03829618
• Other study ID #: STUDY00009727
• Status: Terminated
• Phase: Phase 3
• Start date: April 1, 2019
• Est. completion date: August 31, 2020

Study information

• Verified date: September 2021
• Source: Milton S. Hershey Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 29
• Est. completion date: August 31, 2020
• Est. primary completion date: August 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bronchiectasis
• Bronchiectasis Adult
• Bronchopulmonary Disease
• Cancer, Lung
• Chest--Diseases
• Infiltrates
• Lung Neoplasms
• Lymphadenopathy
• Mediastinal Lymphadenopathy
• Pneumonia

Intervention

Drug:
• Topical lidocaine
1% lidocaine topically applied in 4 mL aliquots
• Nebuliser solution
2% lidocaine dose at 2 mg/kg (max 160 mg) applied via jet nebulizer
• Nebuliser Suspension
2% lidocaine dosed at 2 mg/kg (max 160 mg) applied via vibrating mesh nebulizer

Locations

Country	Name	City	State
United States	Penn State Hershey Medical Center	Hershey	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (5)

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;2 — View Citation

Dreher M, Cornelissen CG, Reddemann MA, Müller A, Hübel C, Müller T. Nebulized versus Standard Local Application of Lidocaine during Flexible Bronchoscopy: A Randomized Controlled Trial. Respiration. 2016;92(4):266-273. Epub 2016 Sep 10. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cough	Number of coughs during procedure as defined by cough requiring stopping procedure or treatment by anesthesiologist with propofol or alfentanyl	1 day
Secondary	Number of Participants With Post-procedure Sore Throat	sore throat was self reported by patient as: none, mild, moderate, severe	1 day
Secondary	Number of Participants With Post-Procedure Subjective Cough	Subjective cough as described by patient as: none, mild, moderate, severe	1 day
Secondary	Anesthesia Time to Wake up	time in minutes from scope out until ready for transport to post anesthesia care unit	1 day
Secondary	Alfentanyl Dosing	Total alfentanyl dosing by anesthesia in mcg/kg	1 day
Secondary	Propofol Dosing	Total propofol dosing by anesthesia in mg/kg	1 day
Secondary	Fentanyl Dosing	total fentanyl dosing by anesthesia in mcg/kg	1 day