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

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

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.

Study Overview

• Status: Completed
• Conditions: Lung Diseases; Total Intravenous Anesthesia; Bronchoscopic Interventions
• Intervention / Treatment: Procedure: bronchoscopic insertion

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 Type: Interventional
• Enrollment (Actual): 108
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan
    • National Taiwan University Cancer Center Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cough score	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.	from bronchoscopic spray local anesthetics on vocal cords to the end of spraying on bonchial trees
BIS levels from EEG monitor	the changes of BIS levels (0-100)	from 1 minutes before bronchoscopic insertion to 20 minutes after bronchoscopic interventions
ANI scores from analgesia-nociception monitor (0-100)	the changes of ANI scores (0-100)	from 1 minutes before bronchoscopic insertion to 20 minutes after bronchoscopic interventions

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MAP	mean arterial pressure, mmHg	from bronchoscopic insertion to 20 minutes after completion of local anesthetic spraying
heart rate	heart rate, beats/ minute	from bronchoscopic insertion to 20 minutes after completion of local anesthetic spraying
SPO2	SPO2, %	from bronchoscopic insertion to 20 minutes after completion of local anesthetic spraying
Transdermal CO2	Transdermal CO2, mmHg	from bronchoscopic insertion to 20 minutes after completion of local anesthetic spraying
BTransdermal O2	Transdermal O2, mmHg	from bronchoscopic insertion to 20 minutes after completion of local anesthetic spraying

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Study Chair: Yajung Cheng, National Taiwan University Hospital, Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): May 9, 2022
• Primary Completion (Actual): June 30, 2024
• Study Completion (Actual): October 30, 2024

Study Registration Dates

• First Submitted: September 14, 2021
• First Submitted That Met QC Criteria: October 5, 2021
• First Posted (Actual): October 8, 2021

Study Record Updates

• Last Update Posted (Estimated): November 19, 2025
• Last Update Submitted That Met QC Criteria: November 16, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: ventilation; cough; desaturation; bronchoscopic interventions
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Lung Diseases; Respiratory Aspiration; Cough; Organic Chemicals; Anilides; Amides; Aniline Compounds; Amines; Acetanilides; Lidocaine
• Other Study ID Numbers: 202107071MIND

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No