BronchoscopyNCT03869528
5 Versus 10 Sprays of Lignocaine for Pharyngeal Anaesthesia During Bronchoscopy
A study testing 5 sprays of 10% lignocaine and 10 sprays of 10% lignocaine in people with Bronchoscopy and Anesthesia, Local, run by All India Institute of Medical Sciences at 2 sites in India.
Trial summary
Flexible bronchoscopy is one of the most widely performed procedures for diagnosis of various bronchopulmonary diseases. Most patients tolerate the procedure well although cough is often reported as a distressing symptom. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bronchoscopy, Anesthesia, Local
- What is being tested?
- 5 sprays of 10% lignocaine and 10 sprays of 10% lignocaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 2 sitesIndia
- Study dates
- 1 Apr 2019to 1 Dec 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All adults ≥ 18 yrs of age undergoing flexible bronchoscopy
Who cannot join
- Uncontrolled hypertension Systolic Blood Pressure >180 mm Hg
- Symptomatic coronary artery disease
- Pregnancy
- Not giving informed consent for the procedure
- Hypoxemia (oxygen saturation [by pulse oximetry] < 92% with Fio2 of ≥ 0.3
- Bronchoscopy performed through an artificial airway
Trial locations and contacts
2 sites in 1 country.
India2 sites, 2 recruiting
- Recruiting
AIIMS
New Delhi, 110029
Karan Madan, MD, DM, drkaranmadan@gmail.com
Anant Mohan, MD, anantmohan@yahoo.com
- Recruiting
AIIMS Rishikesh
Rishikesh
Mayank Mishra, virgodrmayank@gmail.com
Girish Sindhwani
About this study
Official title: A Randomized Controlled Trial to Evaluate the Efficacy of Topical Pharyngeal Anaesthesia Using 5 vs 10 Sprays of 10% Lignocaine During Flexible Bronchoscopy
Flexible bronchoscopy is one of the most widely performed procedures for diagnosis of various bronchopulmonary diseases. Most patients tolerate the procedure well although cough is often reported as a distressing symptom. It is likely that the acceptance of bronchoscopy would be significantly improved with control of cough.
Topical lignocaine is administered during bronchoscopy for local anaesthesia. There is uncertainty regarding the adequate dose of lignocaine sprays for pharyngeal anaesthesia during flexible bronchoscopy. This study would help to determine the optimal dose of lignocaine sprays for pharyngeal anaesthesia during flexible bronchoscopy.
Read the detailed description
For all patients meeting the inclusion criteria, the demographic profile including age, sex, weight and the type of procedures performed during bronchoscopy shall be recorded. A written informed consent will be obtained from all participants. Enrolled patients will be randomized to receive either 5 or 10 sprays of 10% lignocaine to the pharynx. This will be followed by the standard topical anesthesia procedure followed in our institution involving 5ml of 2% lignocaine gel into the nostril. Transnasal flexible bronchoscopy will be performed with additional 1% lignocaine administered as "spray as you go" method. This will be given as 2 ml aliquots- with similar volume in both groups as baseline. Procedure shall be performed with administration of sedation using Midazolam and Fentanyl if required. Primary outcome will be assessed by noting the operator rated overall procedure satisfaction as a VAS scale score.
- Conditions
- Bronchoscopy, Anesthesia, Local
- Being tested
- 5 sprays of 10% lignocaine, 10 sprays of 10% lignocaine
- Keywords
- bronchoscopy, lignocaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5 sprays of 10% lignocaineDrug
Also called 5 sprays
5 sprays of 10% lignocaine
10 sprays of 10% lignocaineDrug
Also called 10 sprays
10 sprays of 10% lignocaine
| Study group | Role | What they receive |
|---|---|---|
| 5 sprays | Active comparator | 5 sprays of 10% lignocaine administered for topical anaesthesia during flexible bronchoscopy Receives: Drug: 5 sprays of 10% lignocaine |
| 10 sprays | Experimental | 10 sprays of 10% lignocaine administered for topical anaesthesia during flexible bronchoscopy Receives: Drug: 10 sprays of 10% lignocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operator rated overall procedure satisfaction
Visual Analogue Scale score (VAS) between 0 to 100
Measured: At study completion at approximately 4 months
Secondary outcomes (5)
Operator rated cough
Visual Analogue score (VAS) between 0 to 100
Measured: At study completion at approximately 4 months
Time from bronchoscope introduction to reaching the vocal cords
Time in seconds
Measured: At study completion at approximately 4 months
Patient willingness to return for repeat bronchoscopy
Proportion of patients willing for repeat bronchoscopy in each group
Measured: At study completion at approximately 4 months
Cumulative lignocaine dose
Total dose of lignocaine in milligram (mg)
Measured: At study completion at approximately 4 months
Complications
Proportion of patients with complications in each group
Measured: At study completion at approximately 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2019
- Study start1 Apr 2019
- Primary completion1 Dec 2021 (estimated)
- Study completion1 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- All India Institute of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karan Madan, All India Institute of Medical Sciences
- Investigators
- Randeep Guleria, MD DM, Study chair, All India Institute of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03869528
- Sponsor's protocol ID
- 510 RCT
- Status last verified
- Jan 2021
- First submitted
- 8 Mar 2019
- Last updated
- 15 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 15 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial to Evaluate the Efficacy of Topical Pharyngeal Anaesthesia Using 5 vs 10 Sprays of 10% Lignocaine During Flexible Bronchoscopy
- ClinicalTrials.gov ID
- NCT03869528
- Acronym / sponsor ID
- 510 RCT
- Conditions
- Bronchoscopy, Anesthesia, Local
- Keywords
- bronchoscopy, lignocaine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- All India Institute of Medical SciencesUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 11 Mar 2019 (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 one of the most widely performed procedures for diagnosis of various bronchopulmonary diseases. Most patients tolerate the procedure well although cough is often reported as a distressing symptom. It is likely that the acceptance of bronchoscopy would be significantly improved with control of cough.
Topical lignocaine is administered during bronchoscopy for local anaesthesia. There is uncertainty regarding the adequate dose of lignocaine sprays for pharyngeal anaesthesia during flexible bronchoscopy. This study would help to determine the optimal dose of lignocaine sprays for pharyngeal anaesthesia during flexible bronchoscopy.
Detailed description
For all patients meeting the inclusion criteria, the demographic profile including age, sex, weight and the type of procedures performed during bronchoscopy shall be recorded. A written informed consent will be obtained from all participants. Enrolled patients will be randomized to receive either 5 or 10 sprays of 10% lignocaine to the pharynx. This will be followed by the standard topical anesthesia procedure followed in our institution involving 5ml of 2% lignocaine gel into the nostril. Transnasal flexible bronchoscopy will be performed with additional 1% lignocaine administered as "spray as you go" method. This will be given as 2 ml aliquots- with similar volume in both groups as baseline. Procedure shall be performed with administration of sedation using Midazolam and Fentanyl if required. Primary outcome will be assessed by noting the operator rated overall procedure satisfaction as a VAS scale score.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| 5 sprays | Active comparator | Drug: 5 sprays of 10% lignocaine5 sprays of 10% lignocaine administered for topical anaesthesia during flexible bronchoscopy |
| 10 sprays | Experimental | Drug: 10 sprays of 10% lignocaine10 sprays of 10% lignocaine administered for topical anaesthesia during flexible bronchoscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All adults ≥ 18 yrs of age undergoing flexible bronchoscopy
Key exclusion criteria (6 listed)
- Uncontrolled hypertension Systolic Blood Pressure >180 mm Hg
- Symptomatic coronary artery disease
- Pregnancy
- Not giving informed consent for the procedure
- Hypoxemia (oxygen saturation [by pulse oximetry] < 92% with Fio2 of ≥ 0.3
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 |
|---|---|---|
| 5 sprays of 10% lignocaineAlso: 5 sprays5 sprays of 10% lignocaine | Drug | 5 sprays |
| 10 sprays of 10% lignocaineAlso: 10 sprays10 sprays of 10% lignocaine | Drug | 10 sprays |
Primary outcome
Operator rated overall procedure satisfaction
Time frame: At study completion at approximately 4 months
Visual Analogue Scale score (VAS) between 0 to 100
5 secondary outcomes
Operator rated cough
Time frame: At study completion at approximately 4 months
Time from bronchoscope introduction to reaching the vocal cords
Time frame: At study completion at approximately 4 months
Patient willingness to return for repeat bronchoscopy
Time frame: At study completion at approximately 4 months
Cumulative lignocaine dose
Time frame: At study completion at approximately 4 months
Complications
Time frame: At study completion at approximately 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2021.
- 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.
Randeep Guleria, MD DM study chair
All India Institute of Medical Sciences
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 5 sprays of 10% lignocaine and 10 sprays of 10% lignocaine in people with Bronchoscopy and Anesthesia, Local, run by All India Institute of Medical Sciences at 2 sites 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 1 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 15 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Karan Madan, MD DM (00911126593488, drkaranmadan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Operator rated overall procedure satisfaction (time frame: At study completion at approximately 4 months). 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 15 Jan 2021.