Bronchopulmonary DiseasesNCT02913300
1% vs. 2 % Lignocaine for Endobronchial Ultrasound Guided Transbronchial Needle Aspiration
A study testing Lignocaine 1% concentration solution and Lignocaine 2% concentration solution in people with Bronchopulmonary Diseases, run by All India Institute of Medical Sciences at 1 site in India.
Trial summary
Endobronchial Ultrasound Guided Transbronchial Needle Aspiration (EBUS -TBNA) is commonly performed for diagnosis of mediastinal pathologies. The procedure can either be performed under general anaesthesia or under moderate sedation with topical anaesthesia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bronchopulmonary Diseases
- What is being tested?
- Lignocaine 1% concentration solution and Lignocaine 2% concentration solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIndia
- Study dates
- May 2016to Jun 2017
- 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
- Indication for diagnostic or therapeutic flexible bronchoscopy
- Age > 18 years
Who cannot join
- Refusal of consent
- Known documented hypersensitivity to lignocaine
- Procedure performed under general anaesthesia
- Pregnancy
- Hypoxemia (oxygen saturation [by pulse oximetry] < 92% with Fio2 of ≥ 0.3
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of 1% Versus 2% Lignocaine for Topical Anaesthesia in Endobronchial Ultrasound Guided Transbronchial Needle Aspiration
Endobronchial Ultrasound Guided Transbronchial Needle Aspiration (EBUS -TBNA) is commonly performed for diagnosis of mediastinal pathologies. The procedure can either be performed under general anaesthesia or under moderate sedation with topical anaesthesia. Most patients tolerate the procedure well although cough is often reported as a distressing symptom. Topical lignocaine is administered during bronchoscopy for local anaesthesia. There is no literature on the efficacy of lower concentrations (1%) versus a higher (2%) during EBUS TBNA. This study would help to determine whether 1% lignocaine is as effective as 2% lignocaine for airway anaesthesia during EBUS-TBNA.
Read the detailed description
For all patients meeting the inclusion criteria, the demographic profile including age, sex, weight, smoking history shall be recorded. A written informed consent will be obtained from all participants. The patients who undergo EBUS-TBNA under moderate sedation would be randomised in a one is to one ratio either to 1% lignocaine or 2% lignocaine group. Prior to EBUS-TBNA, Blood pressure, pulse rate, respiratory rate and pulse oximetry saturation will be recorded at the baseline Patients in both the groups shall be prepared in a similar fashion except for the concentration of lignocaine used. Two different concentration of lignocaine solution will be labelled as solution 'A' or solution 'B' containing either of 1% or 2% lignocaine solution .Operator will be provided either solution A or B based on the initial randomisation.
During the procedure, 1.5ml aliquots of the provided lignocaine solution will be delivered through the bronchoscope using spray-as-you go technique. The total number of aliquots used during the procedure will be recorded. The patients would be monitored for any adverse effects throughout the procedure. The bronchoscopist doing the procedure will be provided 2 VAS charts to mark the severity of cough and overall procedure satisfaction.
Post procedure, patients will record the pain experienced while undergoing the procedure on the faces pain rating scale.
- Conditions
- Bronchopulmonary Diseases
- Being tested
- Lignocaine 1% concentration solution, Lignocaine 2% concentration solution
- Keywords
- Lignocaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lignocaine 1% concentration solutionDrug
Lignocaine 2% concentration solutionDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 % Lignocaine | Active comparator | 1 % Lignocaine administered for topical anaesthesia during EBUS-TBNA Receives: Drug: Lignocaine 1% concentration solution |
| 2 % Lignocaine | Active comparator | 2 % Lignocaine administered for topical anaesthesia during EBUS-TBNA Receives: Drug: Lignocaine 2% concentration solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operator rated cough VAS
Measured: At study completion approximately 6 months
Operator rated overall procedure satisfaction VAS
Measured: At study completion approximately 6 months
Secondary outcomes (3)
Total lignocaine dose administered
Measured: At study completion approximately 6 months
Patient facies pain rating scale
Measured: At study completion approximately 6 months
Procedure related adverse events
Measured: At study completion approximately 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2016 (estimated)
- Study startMay 2016
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchopulmonary DiseasesStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 100 participants (actual)
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
- NCT02913300
- Sponsor's protocol ID
- Lignocaine EBUS RCT
- Status last verified
- Aug 2017
- First submitted
- 21 Sep 2016
- Last updated
- 22 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of 1% Versus 2% Lignocaine for Topical Anaesthesia in Endobronchial Ultrasound Guided Transbronchial Needle Aspiration
- ClinicalTrials.gov ID
- NCT02913300
- Acronym / sponsor ID
- Lignocaine EBUS RCT
- Conditions
- Bronchopulmonary Diseases
- Keywords
- Lignocaine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- All India Institute of Medical SciencesUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 23 Sep 2016 (estimated)
- 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.
Endobronchial Ultrasound Guided Transbronchial Needle Aspiration (EBUS -TBNA) is commonly performed for diagnosis of mediastinal pathologies. The procedure can either be performed under general anaesthesia or under moderate sedation with topical anaesthesia. Most patients tolerate the procedure well although cough is often reported as a distressing symptom. Topical lignocaine is administered during bronchoscopy for local anaesthesia. There is no literature on the efficacy of lower concentrations (1%) versus a higher (2%) during EBUS TBNA. This study would help to determine whether 1% lignocaine is as effective as 2% lignocaine for airway anaesthesia during EBUS-TBNA.
Detailed description
For all patients meeting the inclusion criteria, the demographic profile including age, sex, weight, smoking history shall be recorded. A written informed consent will be obtained from all participants. The patients who undergo EBUS-TBNA under moderate sedation would be randomised in a one is to one ratio either to 1% lignocaine or 2% lignocaine group. Prior to EBUS-TBNA, Blood pressure, pulse rate, respiratory rate and pulse oximetry saturation will be recorded at the baseline Patients in both the groups shall be prepared in a similar fashion except for the concentration of lignocaine used. Two different concentration of lignocaine solution will be labelled as solution 'A' or solution 'B' containing either of 1% or 2% lignocaine solution .Operator will be provided either solution A or B based on the initial randomisation.
During the procedure, 1.5ml aliquots of the provided lignocaine solution will be delivered through the bronchoscope using spray-as-you go technique. The total number of aliquots used during the procedure will be recorded. The patients would be monitored for any adverse effects throughout the procedure. The bronchoscopist doing the procedure will be provided 2 VAS charts to mark the severity of cough and overall procedure satisfaction.
Post procedure, patients will record the pain experienced while undergoing the procedure on the faces pain rating scale.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 % Lignocaine | Active comparator | Drug: Lignocaine 1% concentration solution1 % Lignocaine administered for topical anaesthesia during EBUS-TBNA |
| 2 % Lignocaine | Active comparator | Drug: Lignocaine 2% concentration solution2 % Lignocaine administered for topical anaesthesia during EBUS-TBNA |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Indication for diagnostic or therapeutic flexible bronchoscopy
- Age > 18 years
Key exclusion criteria (5 listed)
- Refusal of consent
- Known documented hypersensitivity to lignocaine
- Procedure performed under general anaesthesia
- Pregnancy
- 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 |
|---|---|---|
| Lignocaine 1% concentration solution | Drug | 1 % Lignocaine |
| Lignocaine 2% concentration solution | Drug | 2 % Lignocaine |
Primary outcome
Operator rated cough VAS
Time frame: At study completion approximately 6 months
Operator rated overall procedure satisfaction VAS
Time frame: At study completion approximately 6 months
3 secondary outcomes
Total lignocaine dose administered
Time frame: At study completion approximately 6 months
Patient facies pain rating scale
Time frame: At study completion approximately 6 months
Procedure related adverse events
Time frame: At study completion approximately 6 months
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 22 Aug 2017.
- Individual participant dataSharing planned: Undecided
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lignocaine 1% concentration solution and Lignocaine 2% concentration solution in people with Bronchopulmonary Diseases, run by All India Institute of Medical Sciences 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 5 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 22 Aug 2017. 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.
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?
Operator rated cough VAS (time frame: At study completion approximately 6 months). The study lists 2 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 22 Aug 2017.