title: Lidocaine spray alone is similar to spray plus viscous solution for pharyngeal observation during transoral endoscopy: a clinical randomized trial.
abstract: Background and study aimsIt is important to examine the pharynx during upper gastrointestinal endoscopy. Pharyngeal anesthesia using topical lidocaine is generally used as pretreatment. In Japan, lidocaine viscous solution is the anesthetic of choice, but lidocaine spray is applied when the former is considered insufficient. However, the relationship between the extent of pharyngeal anesthesia and accuracy of observation is unclear. We compared the performance of lidocaine spray alone versus lidocaine spray combined with lidocaine viscous solution for pharyngeal observation during transoral endoscopy.Patients and methodsIn this prospective, double-blinded, randomized clinical trial conducted between January and March 2015, 327 patients were randomly assigned to lidocaine spray alone (spray group, n = 157) or a combination of spray and viscous solution (combination group, n = 170). We compared the number of pharyngeal observable sites (non-inferiority test), pain by visual analogue scale, observation time, and the number of gag reflexes between the two groups.ResultsThe mean number of images of suitable quality taken at the observable pharyngeal sites in the spray group was 8.33 (95 % confidence interval [CI]: 7.94 - 8.72) per patient, and 8.77 (95 % CI: 8.49 - 9.05) per patient in the combination group. The difference in the number of observable pharyngeal sites was - 0.44 (95 % CI: - 0.84 to - 0.03,P= 0.01). There were no differences in pain, observation time, or number of gag reflexes between the 2 groups. Subgroup analysis of the presence of sedation revealed no differences between the two groups for the number of pharyngeal observation sites and the number of gag reflexes. However, the number of gag reflexes was higher in the spray group compared to the combination group in a subgroup analysis that looked at the absence of sedation.ConclusionsLidocaine spray for pharyngeal anesthesia was not inferior to lidocaine spray and viscous solution in terms of pharyngeal observation. It was considered that lidocaine viscous solution was unnecessary for pharyngeal observation. UMIN000016073.
authors.affiliation: Department of Gastroenterology, Kanazawa University Hospital, Ishikawa, Japan.
authors.forename: Tomoyuki
authors.initials: T
authors.lastname: Hayashi
authors.affiliation: Department of Gastroenterology, Kanazawa University Hospital, Ishikawa, Japan.
authors.forename: Yoshiro
authors.initials: Y
authors.lastname: Asahina
authors.affiliation: Department of Gastroenterology, Kanazawa University Hospital, Ishikawa, Japan.
authors.forename: Yohei
authors.initials: Y
authors.lastname: Waseda
authors.affiliation: Department of Gastroenterology, Kanazawa University Hospital, Ishikawa, Japan.
authors.forename: Kazuya
authors.initials: K
authors.lastname: Kitamura
authors.affiliation: Department of Gastroenterology, Kanazawa University Hospital, Ishikawa, Japan.
authors.forename: Takashi
authors.initials: T
authors.lastname: Kagaya
authors.affiliation: Department of Gastroenterology, Kanazawa University Hospital, Ishikawa, Japan.
authors.forename: Takuya
authors.initials: T
authors.lastname: Seike
authors.affiliation: Department of Gastroenterology, Kanazawa University Hospital, Ishikawa, Japan.
authors.forename: Kazuhiro
authors.initials: K
authors.lastname: Okada
authors.affiliation: Department of Gastroenterology, Kanazawa University Hospital, Ishikawa, Japan.
authors.forename: Yuki
authors.initials: Y
authors.lastname: Inada
authors.affiliation: Department of Gastroenterology, Kanazawa University Hospital, Ishikawa, Japan.
authors.forename: Hisashi
authors.initials: H
authors.lastname: Takabatake
authors.affiliation: Department of Gastroenterology, Kanazawa University Hospital, Ishikawa, Japan.
authors.forename: Noriaki
authors.initials: N
authors.lastname: Orita
authors.affiliation: Department of Gastroenterology, Kanazawa University Hospital, Ishikawa, Japan.
authors.forename: Yuko
authors.initials: Y
authors.lastname: Yanase
authors.affiliation: Department of Gastroenterology, Kanazawa University Hospital, Ishikawa, Japan.
authors.forename: Tatsuya
authors.initials: T
authors.lastname: Yamashita
authors.affiliation: Department of Gastrointestinal Surgery, Kanazawa University Hospital, Ishikawa, Japan.
authors.forename: Itasu
authors.initials: I
authors.lastname: Ninomiya
authors.affiliation: Innovative Clinical Research Center, Kanazawa University Hospital, Ishikawa, Japan.
authors.forename: Kenichi
authors.initials: K
authors.lastname: Yoshimura
authors.affiliation: Department of Gastroenterology, Kanazawa University Hospital, Ishikawa, Japan.
authors.forename: Shuichi
authors.initials: S
authors.lastname: Kaneko