Effects of Adding Different Drugs for Preventing Cough Induced by Bronchoscopic Spraying of Local Anesthetics

Sponsor
National Taiwan University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05072236
Collaborator
(none)
90
1
3
5.7
15.7

Study Details

Study Description

Brief Summary

Cough is the most unwanted response during bronchoscopic interventions for hemodynamic instability, hypoxemia, and interruption of interventions. Topical lidocaine is recommended with a grade evidence in British Thoracic Society guideline. However, severe cough often induces during the initial bronchoscopic spraying of local anesthesia, follows with uneven spraying, spasm or arrythmias. In previous reports, there were many drugs and techniques investigated for preventing cough during broncoscopic spraying. As bronchoscopic interventions need more space and stability of airways to precisely operate on, few studies have focused on the effects of different drugs for preventing cough. In this study, Different intravenous drugs (lidocaine, alfentanil, compared to normal saline) is planned to be injected one minutes before bronchoscopic insertion, the responses to bronchoscopicly spraying local anestheticsuch as cough intensity, BIS levels, ANI, Transdermal O2 and CO2, respiration were recorded and analyzed.

Condition or Disease Intervention/Treatment Phase
  • Procedure: bronchoscopic insertion
N/A

Detailed Description

Cough is the most unwanted response during bronchoscopic interventions. Cough could lead to airway spasm, hemodynamic instability, desaturation, hypoventilation, and then interrupt the following interventions. In previous reports, lodicaine and other drugs given intravenously, inhalationally or trans-cricoidally have been investigated for preventing cough during conventional broncoscopic examinations. As bronchoscopic interventions were goaled to precise localization and operations with higher yield rate. Steady airways without endotracheal tubes are usually required. Topical lidocaine is recommended with a grade evidence in British Thoracic Society guideline. However, severe cough often induces during the initial bronchoscopic spraying of local anesthesia, follows with uneven spraying, spasm or arrythmias. There are few studies focused on the effects of different drugs for preventing cough even bronchoscopic spary of local anesthetics has become the routine pratice before interventions. In this study, different intravenous drugs (lidocaine, alfentanil, compared to normal saline) are planned to be injected one minutes before bronchoscopic insertion, the responses to bronchoscopic spraying local anesthetic were recorded and analyzed. Besdies cough scores, the following changes are recorded and compared: (1) status on visualization and the responses to spraying of vocal cords, (2) anesthetic depth (BIS levels), ANI scores (3) blood pressure and heart beats, (4) data of hemoglobin saturation (SPO2) and Transdermal O2 and CO2. We goaled to compare the effects of intravenous lidocaine and etomidate on cough intensity, hemodynamics, ventilation, and bronchoscopic withdrawl rate during bronchoscopic interventions with intravenous anethesia.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Effects of Adding Intravenous Lidocaine, Alfentanil Before Bronchoscopic Insertion for Preventing Cough During Bronchoscopic Spraying of Local Anesthetics in Non-intubated Bronchoscoopic Interventions
Actual Study Start Date :
May 9, 2022
Anticipated Primary Completion Date :
Aug 30, 2022
Anticipated Study Completion Date :
Oct 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: normal saline

intravenous normal saline 5 mL 1 minute before bronchoscope insertion

Procedure: bronchoscopic insertion
After intravenous anesthesia is stabilized with BIS levels between 50-70, Intravenous lidocaine 1.5 mg/kg, or alfentanil 10 ug/kg, or 5 mL normal saline will be injected. Bronchoscopic insertion will be started 1 minute later. After seeing the vocal cords, local spraying of 2% will be initiated from vocal cords, trachea, and bilateral bronchial trees.
Other Names:
  • bronchoscopic spraying of 2% lidocaine
  • Active Comparator: lidocaine

    intravenous lidocaine 1.5 mg/kg 1 minute before bronchoscope insertion

    Procedure: bronchoscopic insertion
    After intravenous anesthesia is stabilized with BIS levels between 50-70, Intravenous lidocaine 1.5 mg/kg, or alfentanil 10 ug/kg, or 5 mL normal saline will be injected. Bronchoscopic insertion will be started 1 minute later. After seeing the vocal cords, local spraying of 2% will be initiated from vocal cords, trachea, and bilateral bronchial trees.
    Other Names:
  • bronchoscopic spraying of 2% lidocaine
  • Experimental: alfentanil

    intravenous alfentanil 10 ug/kg 1 minute before bronchoscope insertion

    Procedure: bronchoscopic insertion
    After intravenous anesthesia is stabilized with BIS levels between 50-70, Intravenous lidocaine 1.5 mg/kg, or alfentanil 10 ug/kg, or 5 mL normal saline will be injected. Bronchoscopic insertion will be started 1 minute later. After seeing the vocal cords, local spraying of 2% will be initiated from vocal cords, trachea, and bilateral bronchial trees.
    Other Names:
  • bronchoscopic spraying of 2% lidocaine
  • Outcome Measures

    Primary Outcome Measures

    1. cough score [from bronchoscopic spray local anesthetics on vocal cords to the end of spraying on bonchial trees]

      cough severity x times Cough severity was graded on a 5-point scale: minimal cough, 1 point; moderate cough, 2 points; severe cough, 3 points; bouts of coughing, 4 points; and series of bouts of coughing, 5 points.

    2. BIS levels from EEG monitor [from 1 minutes before bronchoscopic insertion to 20 minutes after bronchoscopic interventions]

      the changes of BIS levels (0-100)

    3. ANI scores from analgesia-nociception monitor (0-100) [from 1 minutes before bronchoscopic insertion to 20 minutes after bronchoscopic interventions]

      the changes of ANI scores (0-100)

    Secondary Outcome Measures

    1. MAP [from bronchoscopic insertion to 20 minutes after completion of local anesthetic spraying]

      mean arterial pressure, mmHg

    2. heart rate [from bronchoscopic insertion to 20 minutes after completion of local anesthetic spraying]

      heart rate, beats/ minute

    3. SPO2 [from bronchoscopic insertion to 20 minutes after completion of local anesthetic spraying]

      SPO2, %

    4. Transdermal CO2 [from bronchoscopic insertion to 20 minutes after completion of local anesthetic spraying]

      Transdermal CO2, mmHg

    5. BTransdermal O2 [from bronchoscopic insertion to 20 minutes after completion of local anesthetic spraying]

      Transdermal O2, mmHg

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • patients planned to receive bronchoscopic interventions for lung tumors with intravenous anesthesia.
    Exclusion Criteria:
    • conventional bronchoscopy without interventions such as EBUS, tracheal tumore excision

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 National Taiwan University Cancer Center Hospital Taipei Taiwan

    Sponsors and Collaborators

    • National Taiwan University Hospital

    Investigators

    • Study Chair: Yajung Cheng, National Taiwan University Hospital cancer center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Taiwan University Hospital
    ClinicalTrials.gov Identifier:
    NCT05072236
    Other Study ID Numbers:
    • 202107071MIND
    First Posted:
    Oct 8, 2021
    Last Update Posted:
    May 13, 2022
    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:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by National Taiwan University Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 13, 2022