Nonaka Takashi, Inamori Masahiko, Miyashita Tetsuya, Inoh Yumi, Kanoshima Kenji, Higurashi Takuma, Ohkubo Hidenori, Iida Hiroshi, Fujita Koji, Kusakabe Akihiko, Gotoh Takahisa, Nakajima Atsushi
Department of Gastroenterology, National Hospital Organization Yokohama Medical Center, Yokohama, Japan.
Department of Gastroenterology and Hepatology, Yokohama City University School of Medicine, Yokohama, Japan.
Endosc Int Open. 2018 Jan;6(1):E3-E10. doi: 10.1055/s-0043-122228. Epub 2018 Jan 12.
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).
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.
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, = 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, < 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, < 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 %, = 0.029).
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.
本项前瞻性随机对照试验旨在评估和比较在胃内镜黏膜下剥离术（ESD）期间，使用丙泊酚（PF）和右美托咪定（DEX）联合用药的镇静方案（联合组）与单独使用PF的镇静方案（PF组）在内镜医师满意度、镇静有效性及安全性方面的差异。
纳入58例计划行胃ESD的胃肿瘤患者，并随机分为两组。通过两组间比较评估内镜医师的满意度评分以及镇静有效性和安全性参数。
采用视觉模拟量表测量，联合组内镜医师的满意度评分显著高于PF组（88 vs. 69，P = 0.003）。联合组PF维持剂量低于PF组（2mg/kg/h vs. 5mg/kg/h，P < 0.001），联合组挽救性PF注射次数少于PF组（2次 vs. 6次，P < 0.001）。联合组心动过缓（定义为心率≤45次/分）发生率高于PF组（37.9% vs. 10.3%，P = 0.029）。
本研究表明，在胃ESD期间，由胃肠病学家指导使用PF和DEX联合镇静，可通过提供稳定的镇静效果及可接受的安全性来提高内镜医师的满意度。
