Lidocaine Administration During Flexible Bronchoscopy and Endobronchial Ultrasound

Sponsor
Milton S. Hershey Medical Center (Other)
Overall Status
Terminated
CT.gov ID
NCT03829618
Collaborator
(none)
29
1
3
17
1.7

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
  • Drug: Topical lidocaine
  • Drug: Nebuliser solution
  • Drug: Nebuliser Suspension
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
29 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Lidocaine Administration During Flexible Bronchoscopy and Endobronchial Ultrasound
Actual Study Start Date :
Apr 1, 2019
Actual Primary Completion Date :
Aug 31, 2020
Actual Study Completion Date :
Aug 31, 2020

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:
  • Topical
  • 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:
  • Nebulizer
  • 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:
  • Atomizer
  • Outcome Measures

    Primary Outcome Measures

    1. 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

    1. Number of Participants With Post-procedure Sore Throat [1 day]

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

    2. Number of Participants With Post-Procedure Subjective Cough [1 day]

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

    3. Anesthesia Time to Wake up [1 day]

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

    4. Alfentanyl Dosing [1 day]

      Total alfentanyl dosing by anesthesia in mcg/kg

    5. Propofol Dosing [1 day]

      Total propofol dosing by anesthesia in mg/kg

    6. Fentanyl Dosing [1 day]

      total fentanyl dosing by anesthesia in mcg/kg

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Responsible Party:
    Jennifer Toth, Professor of Medicine and Surgery, Director of Interventional Pulmonology, Milton S. Hershey Medical Center
    ClinicalTrials.gov Identifier:
    NCT03829618
    Other Study ID Numbers:
    • STUDY00009727
    First Posted:
    Feb 4, 2019
    Last Update Posted:
    Oct 12, 2021
    Last Verified:
    Sep 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Additional relevant MeSH terms:

    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

    1. Primary Outcome
    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)
    2. Secondary Outcome
    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%
    3. Secondary Outcome
    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%
    4. Secondary Outcome
    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)
    5. Secondary Outcome
    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)
    6. Secondary Outcome
    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)
    7. Secondary Outcome
    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

    The target enrollment was not reached secondary to the COVID-19 pandemic.

    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
    Email znisnevitchsavarese@pennstatehealth.psu.edu
    Responsible Party:
    Jennifer Toth, Professor of Medicine and Surgery, Director of Interventional Pulmonology, Milton S. Hershey Medical Center
    ClinicalTrials.gov Identifier:
    NCT03829618
    Other Study ID Numbers:
    • STUDY00009727
    First Posted:
    Feb 4, 2019
    Last Update Posted:
    Oct 12, 2021
    Last Verified:
    Sep 1, 2021