Lung DiseasesNCT05072236
Effects of Adding Different Drugs for Preventing Cough Induced by Bronchoscopic Spraying of Local Anesthetics
A study testing bronchoscopic insertion in people with Lung Diseases and Total Intravenous Anesthesia, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Lung Diseases, Total Intravenous Anesthesia, Bronchoscopic Interventions
- What is being tested?
- bronchoscopic insertion
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 1 siteTaiwan
- Study dates
- 9 May 2022to 30 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients planned to receive bronchoscopic interventions for lung tumors with intravenous anesthesia.
Who cannot join
- conventional bronchoscopy without interventions such as EBUS, tracheal tumore excision
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Being tested
- bronchoscopic insertion
- Keywords
- cough, desaturation, ventilation, bronchoscopic interventions
- Medical subject headings
- Lung Diseases, Cough, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bronchoscopic insertionProcedure or surgery
Also called bronchoscopic spraying of 2% lidocaine
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.
| Study group | Role | What they receive |
|---|---|---|
| normal saline | Placebo comparator | intravenous normal saline 5 mL 1 minute before bronchoscope insertion Receives: Procedure: bronchoscopic insertion |
| lidocaine | Active comparator | intravenous lidocaine 1.5 mg/kg 1 minute before bronchoscope insertion Receives: Procedure: bronchoscopic insertion |
| alfentanil | Experimental | intravenous alfentanil 10 ug/kg 1 minute before bronchoscope insertion Receives: Procedure: bronchoscopic insertion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: 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)
Measured: from 1 minutes before bronchoscopic insertion to 20 minutes after bronchoscopic interventions
Secondary outcomes (5)
MAP
mean arterial pressure, mmHg
Measured: from bronchoscopic insertion to 20 minutes after completion of local anesthetic spraying
heart rate
heart rate, beats/ minute
Measured: from bronchoscopic insertion to 20 minutes after completion of local anesthetic spraying
SPO2
SPO2, %
Measured: from bronchoscopic insertion to 20 minutes after completion of local anesthetic spraying
Transdermal CO2
Transdermal CO2, mmHg
Measured: from bronchoscopic insertion to 20 minutes after completion of local anesthetic spraying
BTransdermal O2
Transdermal O2, mmHg
Measured: from bronchoscopic insertion to 20 minutes after completion of local anesthetic spraying
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2021
- Study start9 May 2022
- Primary completion30 Jun 2024
- Study completion30 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung DiseasesStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yajung Cheng, Study chair, National Taiwan University Hospital, Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05072236
- Sponsor's protocol ID
- 202107071MIND
- Status last verified
- Sep 2025
- First submitted
- 14 Sep 2021
- Last updated
- 19 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05072236
- Acronym / sponsor ID
- 202107071MIND
- Keywords
- cough, desaturation, ventilation, bronchoscopic interventions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 9 May 2022 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Oct 2024 (actual)
- First posted
- 8 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| normal saline | Placebo comparator | Procedure: bronchoscopic insertionintravenous normal saline 5 mL 1 minute before bronchoscope insertion |
| lidocaine | Active comparator | Procedure: bronchoscopic insertionintravenous lidocaine 1.5 mg/kg 1 minute before bronchoscope insertion |
| alfentanil | Experimental | Procedure: bronchoscopic insertionintravenous alfentanil 10 ug/kg 1 minute before bronchoscope insertion |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients planned to receive bronchoscopic interventions for lung tumors with intravenous anesthesia.
Key exclusion criteria (1 listed)
- conventional bronchoscopy without interventions such as EBUS, tracheal tumore excision
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bronchoscopic insertionAlso: bronchoscopic spraying of 2% lidocaineAfter 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. | Procedure or surgery | alfentanil, lidocaine, normal saline |
Primary outcome
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.
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)
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)
5 secondary outcomes
MAP
Time frame: from bronchoscopic insertion to 20 minutes after completion of local anesthetic spraying
heart rate
Time frame: from bronchoscopic insertion to 20 minutes after completion of local anesthetic spraying
SPO2
Time frame: from bronchoscopic insertion to 20 minutes after completion of local anesthetic spraying
Transdermal CO2
Time frame: from bronchoscopic insertion to 20 minutes after completion of local anesthetic spraying
BTransdermal O2
Time frame: from bronchoscopic insertion to 20 minutes after completion of local anesthetic spraying
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yajung Cheng study chair
National Taiwan University Hospital, Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bronchoscopic insertion in people with Lung Diseases and Total Intravenous Anesthesia, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cough score (time frame: from bronchoscopic spray local anesthetics on vocal cords to the end of spraying on bonchial trees). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2025.