Kanogawa Naoya, Ogasawara Sadahisa, Ooka Yoshihiko, Inoue Masanori, Wakamatsu Toru, Yokoyama Masayuki, Maruta Susumu, Unozawa Hidemi, Iwanaga Terunao, Sakuma Takafumi, Fujita Naoto, Koroki Keisuke, Kanzaki Hiroaki, Maeda Takahiro, Kobayashi Kazufumi, Kiyono Soichiro, Nakamura Masato, Kondo Takayuki, Saito Tomoko, Motoyama Tenyu, Suzuki Eiichiro, Nakamoto Shingo, Tawada Akinobu, Chiba Tetsuhiro, Arai Makoto, Kanda Tatsuo, Maruyama Hitoshi, Kato Jun, Takemura Ryo, Nozaki-Taguchi Natsuko, Shiroh Isono, Yokosuka Osamu, Kato Naoya
Department of Gastroenterology, Graduate School of Medicine Chiba University Chiba Japan.
Translational Research and Development Center Chiba University Hospital Chiba Japan.
JGH Open. 2020 Dec 22;5(2):273-279. doi: 10.1002/jgh3.12483. eCollection 2021 Feb.
Standardization of the sedation protocol during radiofrequency ablation (RFA) in patients with hepatocellular carcinoma (HCC) is needed. This randomized, single-blind, investigator-initiated trial compared clinical outcomes during and after RFA using propofol and midazolam, respectively, in patients with HCC.
Few- and small-nodule HCC patients (≤3 nodules and ≤3 cm) were randomly assigned to either propofol or midazolam. Patient satisfaction was assessed using a 100-mm visual analog scale (VAS) (1 mm = not at all satisfied, 100 mm = completely satisfied). Sedation recovery rates 1, 2, 3, and 4 h after RFA were evaluated based on Modified Observer's Assessment of Alertness/Sedation (MOAA/S) scores; full recovery was defined as a MOAA/S score of 5.
Between July 2013 and September 2017, 143 patients with HCC were enrolled, and 135 patients were randomly assigned to the treatment group. Compared with midazolam, propofol exhibited similar median procedural satisfaction (propofol: 73.1 mm, midazolam: 76.9 mm, = 0.574). Recovery rates 1 and 2 h after RFA were higher in the propofol group than in the midazolam group. Meanwhile, recovery rates observed 3 and 4 h after RFA were similar in the two groups. The safety profiles during and after RFA were almost identical in the two groups.
Patient satisfaction was almost identical in patients receiving propofol and midazolam sedation during RFA. Propofol sedation resulted in reduced recovery time compared with midazolam sedation in patients with HCC. The safety profiles of both propofol and midazolam sedation during and after RFA were acceptable.
肝细胞癌(HCC)患者在射频消融(RFA)过程中需要镇静方案的标准化。这项随机、单盲、研究者发起的试验比较了HCC患者分别使用丙泊酚和咪达唑仑进行RFA期间及之后的临床结局。
少发及小病灶HCC患者(≤3个结节且≤3 cm)被随机分配至丙泊酚组或咪达唑仑组。使用100 mm视觉模拟量表(VAS)(1 mm = 完全不满意,100 mm = 完全满意)评估患者满意度。根据改良的观察者警觉/镇静评估(MOAA/S)评分评估RFA后1、2、3和4小时的镇静恢复率;完全恢复定义为MOAA/S评分为5分。
2013年7月至2017年9月,143例HCC患者入组,135例患者被随机分配至治疗组。与咪达唑仑相比,丙泊酚表现出相似的中位操作满意度(丙泊酚:73.1 mm,咪达唑仑:76.9 mm,P = 0.574)。丙泊酚组RFA后1和2小时的恢复率高于咪达唑仑组。同时,两组在RFA后3和4小时观察到的恢复率相似。两组在RFA期间及之后的安全性概况几乎相同。
RFA期间接受丙泊酚和咪达唑仑镇静的患者的满意度几乎相同。与咪达唑仑镇静相比,丙泊酚镇静可缩短HCC患者的恢复时间。丙泊酚和咪达唑仑在RFA期间及之后的镇静安全性概况均可接受。