Trial Outcomes & Findings for Lidocaine Administration During Flexible Bronchoscopy and Endobronchial Ultrasound (NCT NCT03829618)
NCT ID: NCT03829618
Last Updated: 2021-10-12
Results Overview
Number of coughs during procedure as defined by cough requiring stopping procedure or treatment by anesthesiologist with propofol or alfentanyl
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
29 participants
Primary outcome timeframe
1 day
Results posted on
2021-10-12
Participant Flow
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.
Participant milestones
| Measure |
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.
Topical lidocaine: 1% lidocaine topically applied in 4 mL aliquots
|
Nebuliser Solution
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
|
Atomizer Solution
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
|
|---|---|---|---|
|
Overall Study
STARTED
|
15
|
7
|
7
|
|
Overall Study
COMPLETED
|
15
|
7
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Lidocaine Administration During Flexible Bronchoscopy and Endobronchial Ultrasound
Baseline characteristics by cohort
| Measure |
Topical Lidocaine
n=15 Participants
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
|
Nebuliser Solution
n=7 Participants
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
|
Atomizer Solution
n=7 Participants
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
n=29 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
66.80 years
STANDARD_DEVIATION 12.81 • n=5 Participants
|
55.57 years
STANDARD_DEVIATION 16.83 • n=7 Participants
|
57.43 years
STANDARD_DEVIATION 14.77 • n=5 Participants
|
61.83 years
STANDARD_DEVIATION 14.75 • n=4 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
7 participants
n=7 Participants
|
7 participants
n=5 Participants
|
29 participants
n=4 Participants
|
|
BMI
|
30.19 kg/m^2
STANDARD_DEVIATION 6.93 • n=5 Participants
|
29.39 kg/m^2
STANDARD_DEVIATION 4.84 • n=7 Participants
|
28.53 kg/m^2
STANDARD_DEVIATION 8.23 • n=5 Participants
|
29.59 kg/m^2
STANDARD_DEVIATION 6.63 • n=4 Participants
|
|
Smoking History
currently smoking
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Smoking History
quit smoking
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Smoking History
never smoked
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 1 dayNumber of coughs during procedure as defined by cough requiring stopping procedure or treatment by anesthesiologist with propofol or alfentanyl
Outcome measures
| Measure |
Topical Lidocaine
n=15 Participants
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
|
Nebuliser Solution
n=7 Participants
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
|
Atomizer Solution
n=7 Participants
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
|
|---|---|---|---|
|
Cough
|
1.20 coughs
Standard Deviation 1.70
|
1.71 coughs
Standard Deviation 1.60
|
1.00 coughs
Standard Deviation 1.00
|
SECONDARY outcome
Timeframe: 1 dayPopulation: The analysis population does not include subjects who left clinic prior to collection of this data
sore throat was self reported by patient as: none, mild, moderate, severe
Outcome measures
| Measure |
Topical Lidocaine
n=11 Participants
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
|
Nebuliser Solution
n=6 Participants
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
|
Atomizer Solution
n=6 Participants
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
|
|---|---|---|---|
|
Number of Participants With Post-procedure Sore Throat
none
|
6 Participants
|
4 Participants
|
2 Participants
|
|
Number of Participants With Post-procedure Sore Throat
mild
|
4 Participants
|
0 Participants
|
3 Participants
|
|
Number of Participants With Post-procedure Sore Throat
moderate
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Post-procedure Sore Throat
severe
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 1 dayPopulation: The analysis population does not include subjects who left clinic prior to collection of this data.
Subjective cough as described by patient as: none, mild, moderate, severe
Outcome measures
| Measure |
Topical Lidocaine
n=11 Participants
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
|
Nebuliser Solution
n=6 Participants
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
|
Atomizer Solution
n=6 Participants
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
|
|---|---|---|---|
|
Number of Participants With Post-Procedure Subjective Cough
none
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Post-Procedure Subjective Cough
moderate
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Post-Procedure Subjective Cough
severe
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Post-Procedure Subjective Cough
mild
|
8 Participants
|
4 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 1 daytime in minutes from scope out until ready for transport to post anesthesia care unit
Outcome measures
| Measure |
Topical Lidocaine
n=15 Participants
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
|
Nebuliser Solution
n=7 Participants
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
|
Atomizer Solution
n=7 Participants
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
|
|---|---|---|---|
|
Anesthesia Time to Wake up
|
8.47 minutes
Standard Deviation 4.02
|
13.00 minutes
Standard Deviation 5.77
|
6.14 minutes
Standard Deviation 3.80
|
SECONDARY outcome
Timeframe: 1 dayTotal alfentanyl dosing by anesthesia in mcg/kg
Outcome measures
| Measure |
Topical Lidocaine
n=15 Participants
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
|
Nebuliser Solution
n=7 Participants
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
|
Atomizer Solution
n=7 Participants
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
|
|---|---|---|---|
|
Alfentanyl Dosing
|
16.61 mcg/kg
Standard Deviation 22.64
|
47.99 mcg/kg
Standard Deviation 37.41
|
4.40 mcg/kg
Standard Deviation 7.42
|
SECONDARY outcome
Timeframe: 1 dayTotal propofol dosing by anesthesia in mg/kg
Outcome measures
| Measure |
Topical Lidocaine
n=15 Participants
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
|
Nebuliser Solution
n=7 Participants
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
|
Atomizer Solution
n=7 Participants
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
|
|---|---|---|---|
|
Propofol Dosing
|
5.30 mg/kg
Standard Deviation 3.23
|
6.93 mg/kg
Standard Deviation 3.36
|
3.26 mg/kg
Standard Deviation 0.81
|
SECONDARY outcome
Timeframe: 1 daytotal fentanyl dosing by anesthesia in mcg/kg
Outcome measures
| Measure |
Topical Lidocaine
n=15 Participants
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
|
Nebuliser Solution
n=7 Participants
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
|
Atomizer Solution
n=7 Participants
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
|
|---|---|---|---|
|
Fentanyl Dosing
|
0.30 mcg/kg
Standard Deviation 0.28
|
0.24 mcg/kg
Standard Deviation 0.23
|
0.48 mcg/kg
Standard Deviation 0.39
|
Adverse Events
Topical Lidocaine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Nebuliser Solution
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Nebuliser Suspension
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Zoulfira Nisnevitch-Savarese, M.D.
Penn State Hershey Medical Center
Phone: 717-531-6597
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place