A Randomized Trial of 181 Patients to Topical Anesthesia with Lidocaine Versus Lidocaine Plus Xylometazoline for Unsedated Ultrathin Transnasal Upper Gastrointestinal Endoscopy

Background: Ultrathin unsedated transnasal endoscopy is an emerging tool for endoscopic evaluation of the upper gastrointestinal tract. Topical anesthesia, with or without a nasal vasoconstrictor/decongestant, is required but the optimal regimen is unknown. Nasal vasconstrictor/decongestants, such as xylometazoline, may potentially improve nasal cavity patency and reduce epistaxis. Objectives: To determine the tolerance and effectiveness of lidocaine versus lidocaine plus xylometazoline for topical anesthesia in unsedated transnasal endoscopy. Methods: Participants were prospectively randomized to lidocaine plus xylometazoline (LX) versus lidocaine (L) for unsedated transnasal 4.9 mm ultrathin endoscopy. The primary outcome was overall procedural discomfort rated on a 10-point scale (1 = no discomfort to 10 = severe discomfort). Secondary outcomes were pain, gagging, endoscopist-rated insertion difficulty, encounter times, epistaxis, and adverse events. For each outcome, the mean ±SD were estimated within treatment groups; differences in the means and 95% CI are presented. Results: A total of 181 patients (mean age 40 ± 17 years) were randomized to LX (n = 94) and L (n = 87). Baseline characteristics were similar in both groups. Overall procedural discomfort was similar for LX and L [4.2 ± 2.4 vs 3.9 ± 2.1, 0.29 (95% CI -0.96,0.39)]. Transnasal insertion difficulty was lower on average with LX compared to L [2.4 ± 2.1 vs 3.2 ± 2.8, -0.80 (95% CI -1.54,-0.06)]. LX, compared to L, was associated with less time needed to apply anesthesia [2.4 ± 1.8 vs 3.5 ± 2.2 min, -1.10 (95% CI -1.71,-0.50)], less time for insertion [3.2 ± 1.8 vs 3.9 ± 2.2 min, -0.70 (95% CI -1.30,-0.10)] and less overall encounter time [21.4 ± 6.0 vs 24.3 ± 5.8 min, -2.90 (95% CI-4.64,-1.09)]. Epistaxis was rare but occurred less frequently with LX compared to L. Conclusions: There was little difference in tolerance between L and LX for unsedated transnasal endoscopy. However, LX was associated with less difficulty with endoscope insertion, and reduced insertion time and epistaxis.