Lidocaine Administration During Flexible Bronchoscopy and Endobronchial Ultrasound
Study Details
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
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:
|
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:
|
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:
|
Outcome Measures
Primary Outcome Measures
- Cough [1 day]
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 [1 day]
sore throat was self reported by patient as: none, mild, moderate, severe
- Number of Participants With Post-Procedure Subjective Cough [1 day]
Subjective cough as described by patient as: none, mild, moderate, severe
- Anesthesia Time to Wake up [1 day]
time in minutes from scope out until ready for transport to post anesthesia care unit
- Alfentanyl Dosing [1 day]
Total alfentanyl dosing by anesthesia in mcg/kg
- Propofol Dosing [1 day]
Total propofol dosing by anesthesia in mg/kg
- Fentanyl Dosing [1 day]
total fentanyl dosing by anesthesia in mcg/kg
Eligibility Criteria
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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Penn State Hershey Medical Center | Hershey | Pennsylvania | United States | 17036 |
Sponsors and Collaborators
- Milton S. Hershey Medical Center
Investigators
- Principal Investigator: Jennifer Toth, Milton S. Hershey Medical Center
Study Documents (Full-Text)
More Information
Publications
- 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.
- 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.
- 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.
- 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.
- STUDY00009727
Study Results
Participant Flow
Recruitment Details | Participants will be Identified from pool of patients who will already be undergoing with planned flexible bronchoscopy and/or endobronchial ultrasound by an interventional pulmonologist in the operating room setting. They will be identified by review of the operating room schedule and through the interventional pulmonology clinic. |
---|---|
Pre-assignment Detail |
Arm/Group Title | Topical Lidocaine | Nebuliser Solution | Atomizer Solution |
---|---|---|---|
Arm/Group Description | 16 ml of 1% lidocaine sprayed in 4 ml aliquots to vocal cords, midtrachea, left main stem bronchus and right main stem bronchus. Topical lidocaine: 1% lidocaine topically applied in 4 mL aliquots | 2% lidocaine dosed at 2mg/kg with max dose of 160mg nebulized via jet nebulizer in operating room over ten minutes. Nebuliser solution: 2% lidocaine dose at 2 mg/kg (max 160 mg) applied via jet nebulizer | 2% lidocaine dosed at 2mg/kg with max dose of 160mg nebulized via vibrating mesh nebulizer in operating room over ten minutes. Nebuliser Suspension: 2% lidocaine dosed at 2 mg/kg (max 160 mg) applied via vibrating mesh nebulizer |
Period Title: Overall Study | |||
STARTED | 15 | 7 | 7 |
COMPLETED | 15 | 7 | 7 |
NOT COMPLETED | 0 | 0 | 0 |
Baseline Characteristics
Arm/Group Title | Topical Lidocaine | Nebuliser Solution | Atomizer Solution | Total |
---|---|---|---|---|
Arm/Group Description | 16 ml of 1% lidocaine sprayed in 4 ml aliquots to vocal cords, midtrachea, left main stem bronchus and right main stem bronchus. Topical lidocaine: 1% lidocaine topically applied in 4 mL aliquots | 2% lidocaine dosed at 2mg/kg with max dose of 160mg nebulized via jet nebulizer in operating room over ten minutes. Nebuliser solution: 2% lidocaine dose at 2 mg/kg (max 160 mg) applied via jet nebulizer | 2% lidocaine dosed at 2mg/kg with max dose of 160mg nebulized via vibrating mesh nebulizer in operating room over ten minutes. Nebuliser Suspension: 2% lidocaine dosed at 2 mg/kg (max 160 mg) applied via vibrating mesh nebulizer | Total of all reporting groups |
Overall Participants | 15 | 7 | 7 | 29 |
Age (years) [Mean (Standard Deviation) ] | ||||
Mean (Standard Deviation) [years] |
66.80
(12.81)
|
55.57
(16.83)
|
57.43
(14.77)
|
61.83
(14.75)
|
Sex: Female, Male (Count of Participants) | ||||
Female |
7
46.7%
|
3
42.9%
|
4
57.1%
|
14
48.3%
|
Male |
8
53.3%
|
4
57.1%
|
3
42.9%
|
15
51.7%
|
Race (NIH/OMB) (Count of Participants) | ||||
American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Asian |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Black or African American |
0
0%
|
1
14.3%
|
0
0%
|
1
3.4%
|
White |
15
100%
|
6
85.7%
|
6
85.7%
|
27
93.1%
|
More than one race |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Unknown or Not Reported |
0
0%
|
0
0%
|
1
14.3%
|
1
3.4%
|
Region of Enrollment (participants) [Number] | ||||
United States |
15
100%
|
7
100%
|
7
100%
|
29
100%
|
BMI (kg/m^2) [Mean (Standard Deviation) ] | ||||
Mean (Standard Deviation) [kg/m^2] |
30.19
(6.93)
|
29.39
(4.84)
|
28.53
(8.23)
|
29.59
(6.63)
|
Smoking History (Count of Participants) | ||||
currently smoking |
4
26.7%
|
3
42.9%
|
1
14.3%
|
8
27.6%
|
quit smoking |
7
46.7%
|
2
28.6%
|
2
28.6%
|
11
37.9%
|
never smoked |
4
26.7%
|
2
28.6%
|
4
57.1%
|
10
34.5%
|
Outcome Measures
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 |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Topical Lidocaine | Nebuliser Solution | Atomizer Solution |
---|---|---|---|
Arm/Group Description | 16 ml of 1% lidocaine sprayed in 4 ml aliquots to vocal cords, midtrachea, left main stem bronchus and right main stem bronchus. Topical lidocaine: 1% lidocaine topically applied in 4 mL aliquots | 2% lidocaine dosed at 2mg/kg with max dose of 160mg nebulized via jet nebulizer in operating room over ten minutes. Nebuliser solution: 2% lidocaine dose at 2 mg/kg (max 160 mg) applied via jet nebulizer | 2% lidocaine dosed at 2mg/kg with max dose of 160mg nebulized via vibrating mesh nebulizer in operating room over ten minutes. Nebuliser Suspension: 2% lidocaine dosed at 2 mg/kg (max 160 mg) applied via vibrating mesh nebulizer |
Measure Participants | 15 | 7 | 7 |
Mean (Standard Deviation) [coughs] |
1.20
(1.70)
|
1.71
(1.60)
|
1.00
(1.00)
|
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 |
Outcome Measure Data
Analysis Population Description |
---|
The analysis population does not include subjects who left clinic prior to collection of this data |
Arm/Group Title | Topical Lidocaine | Nebuliser Solution | Atomizer Solution |
---|---|---|---|
Arm/Group Description | 16 ml of 1% lidocaine sprayed in 4 ml aliquots to vocal cords, midtrachea, left main stem bronchus and right main stem bronchus. Topical lidocaine: 1% lidocaine topically applied in 4 mL aliquots | 2% lidocaine dosed at 2mg/kg with max dose of 160mg nebulized via jet nebulizer in operating room over ten minutes. Nebuliser solution: 2% lidocaine dose at 2 mg/kg (max 160 mg) applied via jet nebulizer | 2% lidocaine dosed at 2mg/kg with max dose of 160mg nebulized via vibrating mesh nebulizer in operating room over ten minutes. Nebuliser Suspension: 2% lidocaine dosed at 2 mg/kg (max 160 mg) applied via vibrating mesh nebulizer |
Measure Participants | 11 | 6 | 6 |
none |
6
40%
|
4
57.1%
|
2
28.6%
|
mild |
4
26.7%
|
0
0%
|
3
42.9%
|
moderate |
1
6.7%
|
2
28.6%
|
1
14.3%
|
severe |
0
0%
|
0
0%
|
0
0%
|
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 |
Outcome Measure Data
Analysis Population Description |
---|
The analysis population does not include subjects who left clinic prior to collection of this data. |
Arm/Group Title | Topical Lidocaine | Nebuliser Solution | Atomizer Solution |
---|---|---|---|
Arm/Group Description | 16 ml of 1% lidocaine sprayed in 4 ml aliquots to vocal cords, midtrachea, left main stem bronchus and right main stem bronchus. Topical lidocaine: 1% lidocaine topically applied in 4 mL aliquots | 2% lidocaine dosed at 2mg/kg with max dose of 160mg nebulized via jet nebulizer in operating room over ten minutes. Nebuliser solution: 2% lidocaine dose at 2 mg/kg (max 160 mg) applied via jet nebulizer | 2% lidocaine dosed at 2mg/kg with max dose of 160mg nebulized via vibrating mesh nebulizer in operating room over ten minutes. Nebuliser Suspension: 2% lidocaine dosed at 2 mg/kg (max 160 mg) applied via vibrating mesh nebulizer |
Measure Participants | 11 | 6 | 6 |
none |
1
6.7%
|
1
14.3%
|
2
28.6%
|
mild |
8
53.3%
|
4
57.1%
|
3
42.9%
|
moderate |
2
13.3%
|
1
14.3%
|
1
14.3%
|
severe |
0
0%
|
0
0%
|
0
0%
|
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 |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Topical Lidocaine | Nebuliser Solution | Atomizer Solution |
---|---|---|---|
Arm/Group Description | 16 ml of 1% lidocaine sprayed in 4 ml aliquots to vocal cords, midtrachea, left main stem bronchus and right main stem bronchus. Topical lidocaine: 1% lidocaine topically applied in 4 mL aliquots | 2% lidocaine dosed at 2mg/kg with max dose of 160mg nebulized via jet nebulizer in operating room over ten minutes. Nebuliser solution: 2% lidocaine dose at 2 mg/kg (max 160 mg) applied via jet nebulizer | 2% lidocaine dosed at 2mg/kg with max dose of 160mg nebulized via vibrating mesh nebulizer in operating room over ten minutes. Nebuliser Suspension: 2% lidocaine dosed at 2 mg/kg (max 160 mg) applied via vibrating mesh nebulizer |
Measure Participants | 15 | 7 | 7 |
Mean (Standard Deviation) [minutes] |
8.47
(4.02)
|
13.00
(5.77)
|
6.14
(3.80)
|
Title | Alfentanyl Dosing |
---|---|
Description | Total alfentanyl dosing by anesthesia in mcg/kg |
Time Frame | 1 day |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Topical Lidocaine | Nebuliser Solution | Atomizer Solution |
---|---|---|---|
Arm/Group Description | 16 ml of 1% lidocaine sprayed in 4 ml aliquots to vocal cords, midtrachea, left main stem bronchus and right main stem bronchus. Topical lidocaine: 1% lidocaine topically applied in 4 mL aliquots | 2% lidocaine dosed at 2mg/kg with max dose of 160mg nebulized via jet nebulizer in operating room over ten minutes. Nebuliser solution: 2% lidocaine dose at 2 mg/kg (max 160 mg) applied via jet nebulizer | 2% lidocaine dosed at 2mg/kg with max dose of 160mg nebulized via vibrating mesh nebulizer in operating room over ten minutes. Nebuliser Suspension: 2% lidocaine dosed at 2 mg/kg (max 160 mg) applied via vibrating mesh nebulizer |
Measure Participants | 15 | 7 | 7 |
Mean (Standard Deviation) [mcg/kg] |
16.61
(22.64)
|
47.99
(37.41)
|
4.40
(7.42)
|
Title | Propofol Dosing |
---|---|
Description | Total propofol dosing by anesthesia in mg/kg |
Time Frame | 1 day |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Topical Lidocaine | Nebuliser Solution | Atomizer Solution |
---|---|---|---|
Arm/Group Description | 16 ml of 1% lidocaine sprayed in 4 ml aliquots to vocal cords, midtrachea, left main stem bronchus and right main stem bronchus. Topical lidocaine: 1% lidocaine topically applied in 4 mL aliquots | 2% lidocaine dosed at 2mg/kg with max dose of 160mg nebulized via jet nebulizer in operating room over ten minutes. Nebuliser solution: 2% lidocaine dose at 2 mg/kg (max 160 mg) applied via jet nebulizer | 2% lidocaine dosed at 2mg/kg with max dose of 160mg nebulized via vibrating mesh nebulizer in operating room over ten minutes. Nebuliser Suspension: 2% lidocaine dosed at 2 mg/kg (max 160 mg) applied via vibrating mesh nebulizer |
Measure Participants | 15 | 7 | 7 |
Mean (Standard Deviation) [mg/kg] |
5.30
(3.23)
|
6.93
(3.36)
|
3.26
(0.81)
|
Title | Fentanyl Dosing |
---|---|
Description | total fentanyl dosing by anesthesia in mcg/kg |
Time Frame | 1 day |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Topical Lidocaine | Nebuliser Solution | Atomizer Solution |
---|---|---|---|
Arm/Group Description | 16 ml of 1% lidocaine sprayed in 4 ml aliquots to vocal cords, midtrachea, left main stem bronchus and right main stem bronchus. Topical lidocaine: 1% lidocaine topically applied in 4 mL aliquots | 2% lidocaine dosed at 2mg/kg with max dose of 160mg nebulized via jet nebulizer in operating room over ten minutes. Nebuliser solution: 2% lidocaine dose at 2 mg/kg (max 160 mg) applied via jet nebulizer | 2% lidocaine dosed at 2mg/kg with max dose of 160mg nebulized via vibrating mesh nebulizer in operating room over ten minutes. Nebuliser Suspension: 2% lidocaine dosed at 2 mg/kg (max 160 mg) applied via vibrating mesh nebulizer |
Measure Participants | 15 | 7 | 7 |
Mean (Standard Deviation) [mcg/kg] |
0.30
(0.28)
|
0.24
(0.23)
|
0.48
(0.39)
|
Adverse Events
Time Frame | Data collected in the post-anesthesia care unit up to 1 hour after procedure | |||||
---|---|---|---|---|---|---|
Adverse Event Reporting Description | ||||||
Arm/Group Title | Topical Lidocaine | Nebuliser Solution | Nebuliser Suspension | |||
Arm/Group Description | 16 ml of 1% lidocaine sprayed in 4 ml aliquots to vocal cords, midtrachea, left main stem bronchus and right main stem bronchus. Topical lidocaine: 1% lidocaine topically applied in 4 mL aliquots | 2% lidocaine dosed at 2mg/kg with max dose of 160mg nebulized via jet nebulizer in operating room over ten minutes. Nebuliser solution: 2% lidocaine dose at 2 mg/kg (max 160 mg) applied via jet nebulizer | 2% lidocaine dosed at 2mg/kg with max dose of 160mg nebulized via vibrating mesh nebulizer in operating room over ten minutes. Nebuliser Suspension: 2% lidocaine dosed at 2 mg/kg (max 160 mg) applied via vibrating mesh nebulizer | |||
All Cause Mortality |
||||||
Topical Lidocaine | Nebuliser Solution | Nebuliser Suspension | ||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/15 (0%) | 0/7 (0%) | 0/7 (0%) | |||
Serious Adverse Events |
||||||
Topical Lidocaine | Nebuliser Solution | Nebuliser Suspension | ||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/15 (0%) | 0/7 (0%) | 0/7 (0%) | |||
Other (Not Including Serious) Adverse Events |
||||||
Topical Lidocaine | Nebuliser Solution | Nebuliser Suspension | ||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/15 (0%) | 0/7 (0%) | 0/7 (0%) |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title | Zoulfira Nisnevitch-Savarese, M.D. |
---|---|
Organization | Penn State Hershey Medical Center |
Phone | 717-531-6597 |
znisnevitchsavarese@pennstatehealth.psu.edu |
- STUDY00009727