Patients With Indication for Flexible BronchoscopyPhase 2/3NCT03109392
A Randomized Trial of 4% Nebulized Lignocaine vs. 10% Lignocaine Spray in Patients Undergoing Flexible Bronchoscopy
A Phase 2/3 study testing Nebulized Lignocaine, Lignocaine spray and Combined spray and nebulization in people with Patients With Indication for Flexible Bronchoscopy, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
Trial summary
Flexible bronchoscopy is common procedure used in the diagnosis and treatment of a variety of tracheobronchial diseases. During routine diagnostic flexible bronchoscopy, the most distressing symptom experienced by the patients is a cough, and control of a cough is vital for a successful procedure. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Patients With Indication for Flexible Bronchoscopy
- What is being tested?
- Nebulized Lignocaine, Lignocaine spray and Combined spray and nebulization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,050 participants
- Where
- 1 siteIndia
- Study dates
- 1 May 2017to 30 Jun 2018
- Phase
- Phase 2/3
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Willing for flexible bronchoscopy procedure a
Who cannot join
- Requirement of intravenous sedation to undergo any procedure including EBUS-TBNA, conventional TBNA, radial EBUS procedure and interventional pulmonary procedures
- Sensitivity to lignocaine
- Hemodynamically unstable patients (SBP < 90 mm Hg)
- Baseline hypoxemia (SpO2 <92% on room air)
- Pregnancy
- Comorbid illness such as heart failure, CKD, chronic liver disease and others
- Failure to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized-controlled Trial to Compare the Effectiveness of 4% Nebulized Lignocaine Versus 10% Lignocaine Spray in Patients Undergoing Flexible Bronchoscopy
Flexible bronchoscopy is common procedure used in the diagnosis and treatment of a variety of tracheobronchial diseases. During routine diagnostic flexible bronchoscopy, the most distressing symptom experienced by the patients is a cough, and control of a cough is vital for a successful procedure. The investigators hypothesized that either nebulized lignocaine or lignocaine spray given alone prior to flexible bronchoscopy for inducing topical anesthesia will have similar efficacy compared to the combination of the two agents.
Read the detailed description
Flexible bronchoscopy is common procedure used in the diagnosis and treatment of a variety of tracheobronchial diseases. The bronchoscope can be used to sample material not only from the visualized regions but also from the more distal pulmonary parenchyma. It is a safe outpatient exam that carries little risk. While performing the procedure most of the patients express some fear of pain, difficulty in breathing, nasopharyngeal irritation, and cough. During routine diagnostic flexible bronchoscopy, the most distressing symptom experienced by the patients is a cough, and control of a cough is vital for a successful procedure. Administration of a topical anaesthetic drug to the upper airway, larynx, and tracheobronchial tree can reduce a cough and patient's discomfort. The most commonly used topical anaesthetic agent in bronchoscopy is lignocaine because of its quick onset and short duration of action with decreased toxicity as compared to other agents. There are several ways to achieve topical anaesthesia in flexible bronchoscopy including nebulization, direct spray, by tracheal injection, or via nasal, or "spray as you go" technique through the working channel of the bronchoscope. The use of topical anaesthesia, sedation, and analgesia during flexible bronchoscopy varies according to physicians, institutions and geographic locations in the world. Generally, moderate sedation is used in bronchoscopy in which patients can respond to verbal commands. Deep sedation is less commonly used in which patients cannot be easily aroused but respond to repeated or painful stimulation.
Antoniades et al. demonstrated that topical lidocaine through the bronchoscope significantly decreased cough frequency and the total dose of sedation required during flexible bronchoscopy. In a randomized controlled trial of 54 patients, Keane et al. concluded that nebulized and sprayed lignocaine have similar efficacy as topical anaesthetics in fiberoptic bronchoscopy but patients preferred the nebulized route. Noitasaeng et.al. concluded in their study that spraying lidocaine took less time to start the procedure, with greater ease of instrumentation, less incidence of hypersecretion, less gag reflex, and smooth operation during the procedure but patients preferred nebulized lidocaine administration.
At the investigators' center, it has been a routine practice to perform flexible bronchoscopy without sedation in patients who require only diagnostic flexible bronchoscopy and assessment of airway anatomy and other routine procedures such as endobronchial biopsy or transbronchial biopsy. Previously, the investigators had shown that 1% lignocaine given by spray-as-you-go method was similar in efficacy to 2% lignocaine for topical anesthesia during routine flexible bronchoscopy. However, in this study both the groups received nebulized lignocaine and lignocaine spray prior to flexible bronchoscopy in addition to lignocaine solution ad lib.
The investigators hypothesized that either nebulized lignocaine or lignocaine spray given alone prior to flexible bronchoscopy for inducing topical anesthesia will have similar efficacy compared to the combination of the two agents.
- Being tested
- Nebulized Lignocaine, Lignocaine spray, Combined spray and nebulization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nebulized LignocaineDrug
2.5 ml of 4% lignocaine will be administered via nebulization prior to bronchoscopy
Lignocaine sprayDrug
10 puffs of 10% (10mg/puff) lignocaine spray will be sprayed at 10 seconds intervals into the pharynx immediately prior to bronchoscopy
Combined spray and nebulizationDrug
Combination of 2.5 ml of 4% lignocaine via nebulization prior to bronchoscopy and 2 puffs of 10% (10mg/puff) lignocaine spray sprayed at 10 seconds intervals into the pharynx immediately prior to bronchoscopy
| Study group | Role | What they receive |
|---|---|---|
| Nebulized lignocaine | Experimental | 2.5 ml of 4% lignocaine will be administered via nebulization prior to bronchoscopy Receives: Drug: Nebulized Lignocaine |
| Lignocaine spray | Experimental | 10 puffs of 10% (10mg/puff) lignocaine spray will be sprayed at 10 seconds intervals into the pharynx immediately prior to bronchoscopy Receives: Drug: Lignocaine spray |
| Combined spray and nebulization | Active comparator | Combination of 2.5 ml of 4% lignocaine via nebulization prior to bronchoscopy and 2 puffs of 10% (10mg/puff) lignocaine spray sprayed at 10 seconds intervals into the pharynx immediately prior to bronchoscopy Receives: Drug: Combined spray and nebulization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-rated intensity of cough on a visual analog scale (VAS)
The cough VAS is a 100-mm scale anchored by no cough on one end and worst cough on the other; the patient will indicate the severity of a cough by marking a line.
Measured: One hour
Secondary outcomes (11)
Pain assessment by the patient using the faces pain rating scale
The Wong-Baker Faces Pain Scale combines the pictures and numbers to allow pain to be rated by the user. The faces range from smiling face to a sad, crying face. A numerical rating is assigned to each face, of which there is 6 total, where zero rating means no pain with smiling face and 10 mean worst pain with crying face
Measured: One hour
Patient-rated VAS of overall satisfaction of the procedure
VAS on a 100-mm scale
Measured: One hour
Operator-rated intensity of cough on a VAS
VAS on a 100-mm scale
Measured: Immediately following the procedure
Total lignocaine dose
Total dose of lignocaine in milligrams
Measured: Immediately following the procedure
Changes in respiratory rate following the procedure
Respiratory rate at baseline and 5 minutes after the procedure
Measured: Baseline and 5 minutes after the procedure
Changes in heart rate following the procedure
Heart rate at baseline, during and 5 minutes after the procedure
Measured: Baseline, during and 5 minutes after the procedure
Changes in blood pressure following the procedure
Blood pressure at baseline and 5 minutes after the procedure
Measured: Baseline and 5 minutes after the procedure
Changes in oxygenation status following the procedure
Pulse oximetric saturation at baseline, during and 5 minutes after the procedure
Measured: Baseline, during and 5 minutes after the procedure
Duration of procedure (in minutes)
The total duration of bronchoscopy procedure in minutes
Measured: Immediately following the completion of flexible bronchoscopy
Willingness of the patient to undergo the procedure yet again, if required
Patient will indicate the willingness to undergo the procedure again, if required by a simple yes or no
Measured: One hour
Adverse reactions related to lignocaine
Arrhythmia, involuntary movements, convulsions, anaphylaxis and bronchospasm
Measured: One hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2017
- Study start1 May 2017
- Primary completion30 Jun 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patients With Indication for Flexible BronchoscopyStudies of the same condition, open and under way.
- 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 2/3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,050 participants (actual)
Sponsor and investigators
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ritesh Agarwal, Post Graduate Institute of Medical Education and Research, Chandigarh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03109392
- Sponsor's protocol ID
- Pulm.Med/2017/001
- Status last verified
- Feb 2021
- First submitted
- 29 Mar 2017
- Last updated
- 23 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dhooria S, Chaudhary S, Ram B, Sehgal IS, Muthu V, Prasad KT, Aggarwal AN, Agarwal R. A Randomized Trial of Nebulized Lignocaine, Lignocaine Spray, or Their Combination for Topical Anesthesia During Diagnostic Flexible Bronchoscopy. Chest. 2020 Jan;157(1):198-204. doi: 10.1016/j.chest.2019.06.018. Epub 2019 Jul 9.
PubMed 31299247
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized-controlled Trial to Compare the Effectiveness of 4% Nebulized Lignocaine Versus 10% Lignocaine Spray in Patients Undergoing Flexible Bronchoscopy
- ClinicalTrials.gov ID
- NCT03109392
- Acronym / sponsor ID
- Pulm.Med/2017/001
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,050 participants (actual)
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, ChandigarhUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 12 Apr 2017 (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.
Flexible bronchoscopy is common procedure used in the diagnosis and treatment of a variety of tracheobronchial diseases. During routine diagnostic flexible bronchoscopy, the most distressing symptom experienced by the patients is a cough, and control of a cough is vital for a successful procedure. The investigators hypothesized that either nebulized lignocaine or lignocaine spray given alone prior to flexible bronchoscopy for inducing topical anesthesia will have similar efficacy compared to the combination of the two agents.
Detailed description
Flexible bronchoscopy is common procedure used in the diagnosis and treatment of a variety of tracheobronchial diseases. The bronchoscope can be used to sample material not only from the visualized regions but also from the more distal pulmonary parenchyma. It is a safe outpatient exam that carries little risk. While performing the procedure most of the patients express some fear of pain, difficulty in breathing, nasopharyngeal irritation, and cough. During routine diagnostic flexible bronchoscopy, the most distressing symptom experienced by the patients is a cough, and control of a cough is vital for a successful procedure. Administration of a topical anaesthetic drug to the upper airway, larynx, and tracheobronchial tree can reduce a cough and patient's discomfort. The most commonly used topical anaesthetic agent in bronchoscopy is lignocaine because of its quick onset and short duration of action with decreased toxicity as compared to other agents. There are several ways to achieve topical anaesthesia in flexible bronchoscopy including nebulization, direct spray, by tracheal injection, or via nasal, or "spray as you go" technique through the working channel of the bronchoscope. The use of topical anaesthesia, sedation, and analgesia during flexible bronchoscopy varies according to physicians, institutions and geographic locations in the world. Generally, moderate sedation is used in bronchoscopy in which patients can respond to verbal commands. Deep sedation is less commonly used in which patients cannot be easily aroused but respond to repeated or painful stimulation.
Antoniades et al. demonstrated that topical lidocaine through the bronchoscope significantly decreased cough frequency and the total dose of sedation required during flexible bronchoscopy. In a randomized controlled trial of 54 patients, Keane et al. concluded that nebulized and sprayed lignocaine have similar efficacy as topical anaesthetics in fiberoptic bronchoscopy but patients preferred the nebulized route. Noitasaeng et.al. concluded in their study that spraying lidocaine took less time to start the procedure, with greater ease of instrumentation, less incidence of hypersecretion, less gag reflex, and smooth operation during the procedure but patients preferred nebulized lidocaine administration.
At the investigators' center, it has been a routine practice to perform flexible bronchoscopy without sedation in patients who require only diagnostic flexible bronchoscopy and assessment of airway anatomy and other routine procedures such as endobronchial biopsy or transbronchial biopsy. Previously, the investigators had shown that 1% lignocaine given by spray-as-you-go method was similar in efficacy to 2% lignocaine for topical anesthesia during routine flexible bronchoscopy. However, in this study both the groups received nebulized lignocaine and lignocaine spray prior to flexible bronchoscopy in addition to lignocaine solution ad lib.
The investigators hypothesized that either nebulized lignocaine or lignocaine spray given alone prior to flexible bronchoscopy for inducing topical anesthesia will have similar efficacy compared to the combination of the two agents.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Nebulized lignocaine | Experimental | Drug: Nebulized Lignocaine2.5 ml of 4% lignocaine will be administered via nebulization prior to bronchoscopy |
| Lignocaine spray | Experimental | Drug: Lignocaine spray10 puffs of 10% (10mg/puff) lignocaine spray will be sprayed at 10 seconds intervals into the pharynx immediately prior to bronchoscopy |
| Combined spray and nebulization | Active comparator | Drug: Combined spray and nebulizationCombination of 2.5 ml of 4% lignocaine via nebulization prior to bronchoscopy and 2 puffs of 10% (10mg/puff) lignocaine spray sprayed at 10 seconds intervals into the pharynx immediately prior to bronchoscopy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age ≥18 years
- Willing for flexible bronchoscopy procedure a
Key exclusion criteria (7 listed)
- Requirement of intravenous sedation to undergo any procedure including EBUS-TBNA, conventional TBNA, radial EBUS procedure and interventional pulmonary procedures
- Sensitivity to lignocaine
- Hemodynamically unstable patients (SBP < 90 mm Hg)
- Baseline hypoxemia (SpO2 <92% on room air)
- Pregnancy
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 |
|---|---|---|
| Nebulized Lignocaine2.5 ml of 4% lignocaine will be administered via nebulization prior to bronchoscopy | Drug | Nebulized lignocaine |
| Lignocaine spray10 puffs of 10% (10mg/puff) lignocaine spray will be sprayed at 10 seconds intervals into the pharynx immediately prior to bronchoscopy | Drug | Lignocaine spray |
| Combined spray and nebulizationCombination of 2.5 ml of 4% lignocaine via nebulization prior to bronchoscopy and 2 puffs of 10% (10mg/puff) lignocaine spray sprayed at 10 seconds intervals into the pharynx immediately prior to bronchoscopy | Drug | Combined spray and nebulization |
Primary outcome
Patient-rated intensity of cough on a visual analog scale (VAS)
Time frame: One hour
The cough VAS is a 100-mm scale anchored by no cough on one end and worst cough on the other; the patient will indicate the severity of a cough by marking a line.
11 secondary outcomes
Pain assessment by the patient using the faces pain rating scale
Time frame: One hour
Patient-rated VAS of overall satisfaction of the procedure
Time frame: One hour
Operator-rated intensity of cough on a VAS
Time frame: Immediately following the procedure
Total lignocaine dose
Time frame: Immediately following the procedure
Changes in respiratory rate following the procedure
Time frame: Baseline and 5 minutes after the procedure
Changes in heart rate following the procedure
Time frame: Baseline, during and 5 minutes after the procedure
Changes in blood pressure following the procedure
Time frame: Baseline and 5 minutes after the procedure
Changes in oxygenation status following the procedure
Time frame: Baseline, during and 5 minutes after the procedure
Duration of procedure (in minutes)
Time frame: Immediately following the completion of flexible bronchoscopy
Willingness of the patient to undergo the procedure yet again, if required
Time frame: One hour
Adverse reactions related to lignocaine
Time frame: One hour
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 23 Feb 2021.
- Derived from this study: PubMed 31299247Dhooria S, Chaudhary S, Ram B, Sehgal IS, Muthu V, Prasad KT, Aggarwal AN, Agarwal R. A Randomized Trial of Nebulized Lignocaine, Lignocaine Spray, or Their Combination for Topical Anesthesia During Diagnostic Flexible Bronchoscopy. Chest. 2020 Jan;157(1):198-204. doi: 10.1016/j.chest.2019.06.018. Epub 2019 Jul 9.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Nebulized Lignocaine, Lignocaine spray and Combined spray and nebulization in people with Patients With Indication for Flexible Bronchoscopy, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
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 2 inclusion and 7 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 23 Feb 2021. 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 India. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Patient-rated intensity of cough on a visual analog scale (VAS) (time frame: One hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03109392, which also lists 1 linked publication.
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 23 Feb 2021.