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

NCT05072236 | Completed

• 1 other identifier: 202107071MIND
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Diseases; Total Intravenous Anesthesia; Bronchoscopic Interventions

Keywords

cough; desaturation; ventilation; bronchoscopic interventions

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• MAP

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

• heart rate

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

• SPO2

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

• Transdermal CO2

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

• BTransdermal O2

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

Study Arms (3)

normal saline

PLACEBO COMPARATOR

intravenous normal saline 5 mL 1 minute before bronchoscope insertion

Procedure: bronchoscopic insertion

lidocaine

ACTIVE COMPARATOR

intravenous lidocaine 1.5 mg/kg 1 minute before bronchoscope insertion

Procedure: bronchoscopic insertion

alfentanil

EXPERIMENTAL

intravenous alfentanil 10 ug/kg 1 minute before bronchoscope insertion

Procedure: bronchoscopic insertion

Interventions

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.

Also known as: bronchoscopic spraying of 2% lidocaine

alfentanil; lidocaine; normal saline

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients planned to receive bronchoscopic interventions for lung tumors with intravenous anesthesia.

You may not qualify if:

• conventional bronchoscopy without interventions such as EBUS, tracheal tumore excision

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Cancer Center Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Lung Diseases; Cough; Respiratory Aspiration

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Yajung Cheng

  National Taiwan University Hospital, Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2021
• First Posted: October 8, 2021
• Study Start: May 9, 2022
• Primary Completion: June 30, 2024
• Study Completion: October 30, 2024
• Last Updated: November 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)