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Lidocaine Administration During Flexible Bronchoscopy and Endobronchial Ultrasound

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ClinicalTrials.gov Identifier: NCT03829618
Recruitment Status : Recruiting
First Posted : February 4, 2019
Last Update Posted : July 31, 2019
Sponsor:
Information provided by (Responsible Party):
Jennifer Toth, Milton S. Hershey Medical Center

Tracking Information
First Submitted Date  ICMJE January 24, 2019
First Posted Date  ICMJE February 4, 2019
Last Update Posted Date July 31, 2019
Actual Study Start Date  ICMJE April 1, 2019
Estimated Primary Completion Date July 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 1, 2019)
Cough [ Time Frame: 1 day ]
Number of coughs during procedure as defined by cough requiring stopping procedure or treatment by anesthesiologist with propofol or alfentanyl
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 1, 2019)
  • Sore Throat [ Time Frame: 1 day ]
    subjective sore throat as described by patient as: none, mild, moderate, severe
  • Subjective Cough [ Time Frame: 1 day ]
    subjective cough as described by patient as: none, mild, moderate, severe
  • anesthesia time to wake up [ Time Frame: 1 day ]
    time in minutes from scope out until ready for transport to post anesthesia care unit
  • alfentanyl dosing [ Time Frame: 1 day ]
    Total alfentanyl dosing by anesthesia in mcg/kg
  • propofol dosing [ Time Frame: 1 day ]
    Total propofol dosing by anesthesia in mg/kg
  • fentanyl dosing [ Time Frame: 1 day ]
    total fentanyl dosing by anesthesia in mcg/kg
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Lidocaine Administration During Flexible Bronchoscopy and Endobronchial Ultrasound
Official Title  ICMJE Lidocaine Administration During Flexible Bronchoscopy and Endobronchial Ultrasound
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Bronchiectasis Adult
  • Mediastinal Lymphadenopathy
  • Pneumonia
  • Chest--Diseases
  • Infiltrates
  • Bronchopulmonary Disease
  • Cancer, Lung
Intervention  ICMJE
  • Drug: Topical lidocaine
    1% lidocaine topically applied in 4 mL aliquots
    Other Name: Topical
  • Drug: Nebuliser solution
    2% lidocaine dose at 2 mg/kg (max 160 mg) applied via jet nebulizer
    Other Name: Nebulizer
  • Drug: Nebuliser Suspension
    2% lidocaine dosed at 2 mg/kg (max 160 mg) applied via vibrating mesh nebulizer
    Other Name: Atomizer
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Topical lidocaine
  • 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.
    Intervention: Drug: Nebuliser solution
  • 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.
    Intervention: Drug: Nebuliser Suspension
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 1, 2019)
48
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 1, 2020
Estimated Primary Completion Date July 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Lauren Ventola, MD 732-610-1510 lventola@pennstatehealth.psu.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03829618
Other Study ID Numbers  ICMJE STUDY00009727
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Jennifer Toth, Milton S. Hershey Medical Center
Study Sponsor  ICMJE Milton S. Hershey Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jennifer Toth Milton S. Hershey Medical Center
PRS Account Milton S. Hershey Medical Center
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP