Abstract
BACKGROUND AND STUDY AIMS: The aim of this pilot randomized controlled trial was to evaluate and compare the satisfaction of the endoscopist along with the effectiveness and safety of sedation between sedation protocol using a combination of propofol (PF) and dexmedetomidine (DEX) (Combination group) and sedation protocol using PF alone (PF group) during gastric endoscopic submucosal dissection (ESD). PATIENTS AND METHODS: Fifty-eight patients with gastric neoplasias scheduled for gastric ESD were enrolled and randomly assigned to the two groups. The satisfaction scores of the endoscopists and the parameters for the effectiveness and safety of sedation were evaluated by comparisons between the two groups. RESULTS: The satisfaction scores of the endoscopists, which were measured using a visual analogue scale, were significantly higher in the Combination group than in the PF group (88 vs. 69, P = 0.003). The maintenance dose of PF was lower in the Combination group than in the PF group (2 mg/kg/h vs. 5 mg/kg/h, P < 0.001), and the number of rescue PF injections was fewer in the Combination group than in the PF group (2 times vs. 6 times, P < 0.001). The incidence of bradycardia (defined as a pulse rate ≤ 45 bpm) in the Combination group was higher than that in the PF group (37.9 % vs. 10.3 %, P = 0.029). CONCLUSIONS: This study suggests that gastroenterologist-directed sedation using a combination of PF and DEX during gastric ESD can enhance the satisfaction levels of endoscopists by providing stable sedation with an acceptable safety profile.