Nebulized lignocaine for topical anaesthesia in no-sedation bronchoscopy (NEBULA): A randomized, double blind, placebo-controlled trial.

The role of nebulized lignocaine administration for flexible bronchoscopy is unclear. Methods: In this randomized, double‑blind, placebo‑controlled trial, subjects undergoing diagnostic flexible bronchoscopy were randomized to receive either nebulized lignocaine (2.5 ml of 4% lignocaine) or nebulized (2.5 ml of 0.9%) saline (placebo). All received 10% lignocaine pharyngeal spray (4 sprays) and 5‑ml nasal 2% lignocaine gel. 1% lignocaine solution was used for spray‑as‑you‑go administration in all. Co‑primary outcomes were Operator‑rated overall procedure satisfaction and Operator‑rated cough scores on Visual Analog Scale (VAS). Secondary objectives were cumulative lignocaine dose, proportion of subjects receiving >8.2‑mg/kg lignocaine, and complications between the groups. Results: Two hundred and twenty subjects were randomized and 217 (109 – nebulized lignocaine and 108 – placebo) received the intervention. Baseline characteristics were comparable. Operator‑rated overall procedure satisfaction scores on VAS (7.30 ± 1.54 nebulized lignocaine and 7.50 ± 1.31 placebo group, P = 0.85) and Operator‑rated cough scores on VAS (3 [2–5] nebulized lignocaine and 3 [2–4] placebo group, P = 0.18) were similar. Cumulative lignocaine dose was significantly greater in nebulized lignocaine group (331.46 ± 9.41 mg vs. 232.22 ± 12.77 mg, P < 0.001), and a significantly greater number of subjects in this group received lignocaine dose >8.2 mg/kg. Minor complications occurred in 6 and 9 subjects in nebulized lignocaine and placebo groups, respectively, P = 0.41. Conclusion: Administration of nebulized lignocaine in addition to pharyngeal lignocaine spray, during no‑sedation bronchoscopy, increases the cumulative lignocaine dose without improved procedural comfort. Additional nebulized lignocaine during bronchoscopy is not recommended. [ABSTRACT FROM AUTHOR]