title: Pethidine hydrochloride is a better sedation method for pharyngeal observation by transoral endoscopy compared with no sedation and midazolam.
abstract: OBJECTIVE
  Standard surveillance methods for pharyngeal cancer have not been established. We conducted a randomized controlled trial to investigate the best sedation method for pharyngeal observation using transoral endoscopy.
  
  
  METHODS
  In total, 120 patients who underwent surveillance or diagnostic examinations for esophageal cancer were enrolled and divided equally into three groups (no sedation, midazolam, or pethidine hydrochloride). In the midazolam group, midazolam was given i.v. maintaining a Ramsay score of 3. In the pethidine group, pethidine hydrochloride (35 mg) given i.v. Seven sites in five pharyngeal regions were observed on insertion of the endoscope, and graded (0 = poor, 1 = good). After examination, the five pharyngeal regions were scored using a seven-point scale. Primary endpoint was the total score from the five pharyngeal regions. Secondary endpoints were the proportion of the perfect score using the seven-point scale, discomfort score, and adverse events.
  
  
  RESULTS
  Mean total scores for the no sedation group, the midazolam group and the pethidine group were 5.7, 5.5, and 6.8, respectively (P < 0.0001). Proportion of patients with a perfect score for the no sedation group, the midazolam group and the pethidine group were 53%, 35%, and 89%, respectively (P < 0.0001). The pethidine group had better results than the other two groups. Discomfort score and adverse events were low in the pethidine group.
  
  
  CONCLUSIONS
  Pethidine hydrochloride is a feasible and safe sedation method, and was superior to no sedation and midazolam regarding pharyngeal observation of esophageal cancer patients.
authors.affiliation: Department of Gastrointestinal Oncology, Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka, Japan.
authors.forename: Yasushi
authors.initials: Y
authors.lastname: Yamasaki
authors.affiliation: Department of Gastrointestinal Oncology, Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka, Japan.
authors.forename: Ryu
authors.initials: R
authors.lastname: Ishihara
authors.affiliation: Department of Gastrointestinal Oncology, Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka, Japan.
authors.forename: Noboru
authors.initials: N
authors.lastname: Hanaoka
authors.affiliation: Department of Gastrointestinal Oncology, Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka, Japan.
authors.forename: Noriko
authors.initials: N
authors.lastname: Matsuura
authors.affiliation: Department of Gastrointestinal Oncology, Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka, Japan.
authors.forename: Takashi
authors.initials: T
authors.lastname: Kanesaka
authors.affiliation: Department of Gastrointestinal Oncology, Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka, Japan.
authors.forename: Tomofumi
authors.initials: T
authors.lastname: Akasaka
authors.affiliation: Department of Gastrointestinal Oncology, Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka, Japan.
authors.forename: Minoru
authors.initials: M
authors.lastname: Kato
authors.affiliation: Department of Gastrointestinal Oncology, Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka, Japan.
authors.forename: Kenta
authors.initials: K
authors.lastname: Hamada
authors.affiliation: Department of Gastrointestinal Oncology, Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka, Japan.
authors.forename: Yusuke
authors.initials: Y
authors.lastname: Tonai
authors.affiliation: Department of Gastrointestinal Oncology, Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka, Japan.
authors.forename: Sachiko
authors.initials: S
authors.lastname: Yamamoto
authors.affiliation: Department of Gastrointestinal Oncology, Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka, Japan.
authors.forename: Yoji
authors.initials: Y
authors.lastname: Takeuchi
authors.affiliation: Department of Gastrointestinal Oncology, Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka, Japan.
authors.forename: Koji
authors.initials: K
authors.lastname: Higashino
authors.affiliation: Department of Gastrointestinal Oncology, Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka, Japan.
authors.forename: Noriya
authors.initials: N
authors.lastname: Uedo
authors.affiliation: Center for Cancer Control and Statistics, Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka, Japan.
authors.forename: Yuri
authors.initials: Y
authors.lastname: Ito
authors.affiliation: Department of Surgery, Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka, Japan.
authors.forename: Masahiko
authors.initials: M
authors.lastname: Yano
authors.affiliation: Department of Gastrointestinal Oncology, Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka, Japan.
authors.forename: Hiroyasu
authors.initials: H
authors.lastname: Iishi
mesh_terms: D000368:Aged; D000701:Analgesics, Opioid / Q000008:administration & dosage; D018686:Anesthetics, Intravenous / Q000008:administration & dosage; D001706:Biopsy; D016292:Procedural Sedation / Q000379:methods*; D004305:Dose-Response Relationship, Drug; D019723:Endoscopes; D004938:Esophageal Neoplasms / Q000175:diagnosis*; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008614:Meperidine / Q000008:administration & dosage*; D008874:Midazolam / Q000008:administration & dosage*; D009061:Mouth Mucosa / Q000000981:diagnostic imaging; D010614:Pharynx / Q000000981:diagnostic imaging*; D012189:Retrospective Studies
chemical_list: D000701:Analgesics, Opioid; D018686:Anesthetics, Intravenous; D008614:Meperidine; D008874:Midazolam
keywords: conscious sedation; endoscopy; midazolam; pethidine; pharynx