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Lidocaine Administration During Flexible Bronchoscopy and Endobronchial Ultrasound

Primary Purpose

Bronchiectasis Adult, Mediastinal Lymphadenopathy, Pneumonia

Status

Terminated

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Topical lidocaine

Nebuliser solution

Nebuliser Suspension

About this trial

This is an interventional treatment trial for Bronchiectasis Adult

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Penn State Hershey Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

Topical Lidocaine

Nebuliser Solution

Nebuliser Suspension

Arm Description

16 ml of 1% lidocaine sprayed in 4 ml aliquots to vocal cords, midtrachea, left main stem bronchus and right main stem bronchus.

2% lidocaine dosed at 2mg/kg with max dose of 160mg nebulized via jet nebulizer in operating room over ten minutes.

2% lidocaine dosed at 2mg/kg with max dose of 160mg nebulized via vibrating mesh nebulizer in operating room over ten minutes.

Outcomes

Primary Outcome Measures

Cough

Number of coughs during procedure as defined by cough requiring stopping procedure or treatment by anesthesiologist with propofol or alfentanyl

Secondary Outcome Measures

Number of Participants With Post-procedure Sore Throat

sore throat was self reported by patient as: none, mild, moderate, severe

Number of Participants With Post-Procedure Subjective Cough

Subjective cough as described by patient as: none, mild, moderate, severe

Anesthesia Time to Wake up

time in minutes from scope out until ready for transport to post anesthesia care unit

Alfentanyl Dosing

Total alfentanyl dosing by anesthesia in mcg/kg

Propofol Dosing

Total propofol dosing by anesthesia in mg/kg

Fentanyl Dosing

total fentanyl dosing by anesthesia in mcg/kg

Full Information

NCT ID

NCT03829618

First Posted

January 24, 2019

Last Updated

October 8, 2021

Sponsor

Milton S. Hershey Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT03829618

Brief Title

Lidocaine Administration During Flexible Bronchoscopy and Endobronchial Ultrasound

Official Title

Lidocaine Administration During Flexible Bronchoscopy and Endobronchial Ultrasound

Study Type

Interventional

2. Study Status

Record Verification Date

September 2021

Overall Recruitment Status

Terminated

Why Stopped

COVID lack of cases/recruitment

Study Start Date

April 1, 2019 (Actual)

Primary Completion Date

August 31, 2020 (Actual)

Study Completion Date

August 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Milton S. Hershey Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

29 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Topical Lidocaine

Arm Type

Active Comparator

Arm Description

16 ml of 1% lidocaine sprayed in 4 ml aliquots to vocal cords, midtrachea, left main stem bronchus and right main stem bronchus.

Arm Title

Nebuliser Solution

Arm Type

Active Comparator

Arm Description

2% lidocaine dosed at 2mg/kg with max dose of 160mg nebulized via jet nebulizer in operating room over ten minutes.

Arm Title

Nebuliser Suspension

Arm Type

Active Comparator

Arm Description

2% lidocaine dosed at 2mg/kg with max dose of 160mg nebulized via vibrating mesh nebulizer in operating room over ten minutes.

Intervention Type

Drug

Intervention Name(s)

Topical lidocaine

Other Intervention Name(s)

Topical

Intervention Description

1% lidocaine topically applied in 4 mL aliquots

Intervention Type

Drug

Intervention Name(s)

Nebuliser solution

Other Intervention Name(s)

Nebulizer

Intervention Description

2% lidocaine dose at 2 mg/kg (max 160 mg) applied via jet nebulizer

Intervention Type

Drug

Intervention Name(s)

Nebuliser Suspension

Other Intervention Name(s)

Atomizer

Intervention Description

2% lidocaine dosed at 2 mg/kg (max 160 mg) applied via vibrating mesh nebulizer

Primary Outcome Measure Information:

Title

Cough

Description

Number of coughs during procedure as defined by cough requiring stopping procedure or treatment by anesthesiologist with propofol or alfentanyl

Time Frame

1 day

Secondary Outcome Measure Information:

Title

Number of Participants With Post-procedure Sore Throat

Description

sore throat was self reported by patient as: none, mild, moderate, severe

Time Frame

1 day

Title

Number of Participants With Post-Procedure Subjective Cough

Description

Subjective cough as described by patient as: none, mild, moderate, severe

Time Frame

1 day

Title

Anesthesia Time to Wake up

Description

time in minutes from scope out until ready for transport to post anesthesia care unit

Time Frame

1 day

Title

Alfentanyl Dosing

Description

Total alfentanyl dosing by anesthesia in mcg/kg

Time Frame

1 day

Title

Propofol Dosing

Description

Total propofol dosing by anesthesia in mg/kg

Time Frame

1 day

Title

Fentanyl Dosing

Description

total fentanyl dosing by anesthesia in mcg/kg

Time Frame

1 day

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jennifer Toth

Organizational Affiliation

Milton S. Hershey Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Penn State Hershey Medical Center

City

Hershey

State/Province

Pennsylvania

ZIP/Postal Code

17036

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

29346249

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.

Results Reference

background

PubMed Identifier

16162784

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.

Results Reference

background

PubMed Identifier

22045879

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.

Results Reference

background

PubMed Identifier

27614989

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.

Results Reference

background

PubMed Identifier

28891835

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.

Results Reference

result

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Lidocaine Administration During Flexible Bronchoscopy and Endobronchial Ultrasound

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