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NCT Number: NCT05072236

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

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.

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Key information

Conditions

Lung Diseases Bronchoscopic Interventions Cough Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Aspiration Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory Total Intravenous Anesthesia

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Taiwan University Cancer Center Hospital

Taipei, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

bronchoscopic insertion

Procedure

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

Primary outcomes

  1. cough score

    Time frame: 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

    Time frame: 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)

    Time frame: from 1 minutes before bronchoscopic insertion to 20 minutes after bronchoscopic interventions

    the changes of ANI scores (0-100)

Secondary outcomes

  1. MAP

    Time frame: from bronchoscopic insertion to 20 minutes after completion of local anesthetic spraying

    mean arterial pressure, mmHg

  2. heart rate

    Time frame: from bronchoscopic insertion to 20 minutes after completion of local anesthetic spraying

    heart rate, beats/ minute

  3. SPO2

    Time frame: from bronchoscopic insertion to 20 minutes after completion of local anesthetic spraying

    SPO2, %

  4. Transdermal CO2

    Time frame: from bronchoscopic insertion to 20 minutes after completion of local anesthetic spraying

    Transdermal CO2, mmHg

  5. BTransdermal O2

    Time frame: from bronchoscopic insertion to 20 minutes after completion of local anesthetic spraying

    Transdermal O2, mmHg

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

Effects of Adding Intravenous Lidocaine, Alfentanil Before Bronchoscopic Insertion for Preventing Cough During Bronchoscopic Spraying of Local Anesthetics in Non-intubated Bronchoscoopic Interventions

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Oct 8, 2021
Registry last updated
Nov 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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