An interventional study of Lignocaine 1% concentration solution and Lignocaine 2% concentration solution in Bronchopulmonary Diseases, sponsored by All India Institute of Medical Sciences, New Delhi. Completed at 1 site in India. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-08-22.
Sponsored by All India Institute of Medical Sciences, New Delhi · Not applicable, Interventional, and Diagnostic
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.
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.
All India Institute of Medical Sciences, New Delhi is the lead sponsor of 146 studies on the registry; 16 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
1 % Lignocaine administered for topical anaesthesia during EBUS-TBNA
Drug: Lignocaine 1% concentration solution
2 % Lignocaine administered for topical anaesthesia during EBUS-TBNA
Drug: Lignocaine 2% concentration solution
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
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
Plan to share: Undecided
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This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.
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All India Institute of Medical Sciences, New Delhi