BACKGROUND AND AIM: 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. CONCLUSION:Pethidine hydrochloride is a feasible and safe sedation method, and was superior to no sedation and midazolam regarding pharyngeal observation of esophageal cancer patients.
RCT Entities:
BACKGROUND AND AIM: 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. CONCLUSION:Pethidine hydrochloride is a feasible and safe sedation method, and was superior to no sedation and midazolam regarding pharyngeal observation of esophageal cancerpatients.