An interventional study of Lignocaine Nebulization and Saline Nebulization in Bronchopulmonary Disease, 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 2018-01-30.
Sponsored by All India Institute of Medical Sciences, New Delhi · Not applicable, Interventional, and Diagnostic
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. Use of sedation during bronchoscopy has been reported to improve procedure tolerance. However, awake(no sedation) bronchoscopy is routinely performed at many centres including ours.
Topical lignocaine is administered during bronchoscopy for local anaesthesia. There is limited literature on the efficacy of lignocaine delivered with the nebulized route during awake flexible bronchoscopy. This study would help to determine the utility of nebulized lignocaine in airway anaesthesia during flexible bronchoscopy.
For all patients meeting the inclusion criteria, the demographic profile including age, sex, weight, smoking history and the type of procedures performed during bronchoscopy shall be recorded. A written informed consent will be obtained from all participants. The patients who undergo flexible bronchoscopy would be randomised in a one is to one ratio either to nebulized lignocaine (4%) or saline (placebo) nebulization group. Prior to the bronchoscopy 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 nebulized lignocaine. Patient, Operator, outcome assessor will be blinded to the allocation.
During the procedure, 1.5ml aliquots of 1% lignocaine will be delivered through the bronchoscope using spray-as-you go technique. 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 144 studies on the registry; 14 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
4% Lignocaine administered as nebulization for topical anaesthesia during bronchoscopy procedure
Drug: Lignocaine Nebulization
Normal Saline administered as nebulization for topical anaesthesia during bronchoscopy procedure
Drug: Saline Nebulization
4% Lignocaine delivered via Nebulization
Normal Saline Delivered via Nebulization
Operator rated overall procedure satisfaction VAS
Time frame: At study completion approx. 12 months
Operator rated cough VAS
Time frame: At study completion approx. 12 months
Total dose of Lignocaine administered (mg)
Time frame: At study completion approx. 12 months
Number of patients receiving dose >8.2mg/Kg
Time frame: At study completion approx. 12 months
Plan to share: Undecided
No publications or documents are linked to this record.
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All India Institute of Medical Sciences, New Delhi