Randomized Clinical Trial - Necessity of Pharyngeal Anesthesia in Pharyngeal Observation during Transoral Upper Gastrointestinal Endoscopy: A Randomized Clinical Trial

Abstract

BACKGROUND Pharyngeal anesthesia’s role in improving observational ability during upper gastrointestinal endoscopy is controversial. No randomized controlled trials have evaluated observational ability with and without pharyngeal anesthesia (PA + vs. PA- group) under sedation with midazolam. We report the non-inferiority of the PA- group in the pharyngeal observation success rate. METHODS This prospective, single-blinded, randomized study included 500 patients, randomly allocated to PA + or PA- groups (250 cases/group), undergoing transoral upper gastrointestinal endoscopy under intravenous sedation with midazolam. RESULTS The pharyngeal observation success rate was 72.0% and 84.0% in the PA- and PA + groups, respectively; non-inferiority in PA- group was not observed (p = 0.707). In the PA- group, observable sites were fewer (8.33 vs 8.86, p = 0.006), time was longer (67.2 vs. 58.2 s, p = 0.001), and pain scores were higher. Image quality at the posterior wall of oropharynx, vocal fold and pyriform sinus was significantly inferior in PA- group. Subgroup analysis showed a higher sedation level (Ramsay score ≥ 5); no differences in the pharyngeal observation success rate were observed between the groups. CONCLUSION Pharyngeal anesthesia may improve pharyngeal observation ability in the hypopharynx and reduce pain. However, this difference may be reduced with deeper sedation.