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Lidocaine Administration During Flexible Bronchoscopy and Endobronchial Ultrasound

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ClinicalTrials.gov Identifier: NCT03829618
Recruitment Status : Not yet recruiting
First Posted : February 4, 2019
Last Update Posted : February 4, 2019
Sponsor:
Information provided by (Responsible Party):
Jennifer Toth, Milton S. Hershey Medical Center

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
Bronchiectasis Adult Mediastinal Lymphadenopathy Pneumonia Chest--Diseases Infiltrates Bronchopulmonary Disease Cancer, Lung Drug: Topical lidocaine Drug: Nebuliser solution Drug: Nebuliser Suspension Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Lidocaine Administration During Flexible Bronchoscopy and Endobronchial Ultrasound
Estimated Study Start Date : February 4, 2019
Estimated Primary Completion Date : July 1, 2019
Estimated Study Completion Date : July 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cough

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 Name: 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 Name: 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 Name: Atomizer




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Sore Throat [ Time Frame: 1 day ]
    subjective sore throat as described by patient as: none, mild, moderate, severe

  2. Subjective Cough [ Time Frame: 1 day ]
    subjective cough as described by patient as: none, mild, moderate, severe

  3. anesthesia time to wake up [ Time Frame: 1 day ]
    time in minutes from scope out until ready for transport to post anesthesia care unit

  4. alfentanyl dosing [ Time Frame: 1 day ]
    Total alfentanyl dosing by anesthesia in mcg/kg

  5. propofol dosing [ Time Frame: 1 day ]
    Total propofol dosing by anesthesia in mg/kg

  6. fentanyl dosing [ Time Frame: 1 day ]
    total fentanyl dosing by anesthesia in mcg/kg



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03829618


Contacts
Contact: Lauren Ventola, MD 732-610-1510 lventola@pennstatehealth.psu.edu

Sponsors and Collaborators
Milton S. Hershey Medical Center
Investigators
Principal Investigator: Jennifer Toth Milton S. Hershey Medical Center

Publications of Results:
Other Publications:
Responsible Party: Jennifer Toth, Professor of Medicine and Surgery, Director of Interventional Pulmonology, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT03829618     History of Changes
Other Study ID Numbers: STUDY00009727
First Posted: February 4, 2019    Key Record Dates
Last Update Posted: February 4, 2019
Last Verified: February 2019

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:
Bronchiectasis
Pneumonia
Lymphadenopathy
Lung Neoplasms
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Bronchial Diseases
Lymphatic Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action