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双频指数监测下的异丙酚镇静有益于内镜黏膜下剥离:一项随机前瞻性II期临床试验

发布日期:2014-1-29 12:40:43 文章来源:ENDOSCOPY 作者次数:1138
    双频指数监测下的异丙酚镇静有益于内镜黏膜下剥离:一项随机前瞻性II期临床试验

    T. Sasaki, S. Tanabe, M. Azuma, A. Sato, A. Naruke, K. Ishido, C. Katada, K. Higuchi, W. Koizumi

    日本神奈川县北里大学医学院消化内科

    背景与研究目的:内镜黏膜下剥离术(ESD)已成为一个标准治疗方法。然而,其治疗时间往往比较长,而且内镜下充气和操作会加重患者的疼痛和不适感。故我们的目的是找到一种为实施内镜黏膜下剥离术而采用的最佳镇静方法。

    患者与方法:一些早期胃癌或腺瘤患者计划接受内镜黏膜下剥离术,他们被随机安排接受咪达唑仑或异丙酚镇静,同时采用双频指数(BIS)监测法评估其意识水平。我们对各自内镜黏膜下剥离术期间以及返回病房后的主要有效性终点(三个参数)和次要安全性终点进行了比较。本研究注册于UMIN临床试验注册处(UMIN 000001497),机构试验编号是KDOG 0801

    结果:自20086月至20096月,我们共纳入178例患者,其中,90例采用咪达唑仑镇静,88例采用异丙酚镇静。关于内镜黏膜下剥离术后安全性情况如下,异丙酚镇静组于术后即刻以及返回病房后1小时、2小时时的康复情况显著优于咪达唑仑组(P < 0.001)。异丙酚镇静组中,需返回病房后继续供氧的患者数量显著低于咪达唑仑组,即咪达唑仑组有18例,异丙酚组有6例,P = 0.010。尽管异丙酚看起来有着更好的有效性和安全性,但二者的三个主要终点和安全性参数(低血压、低氧和心动过缓)均无显著统计学差异。

    结论:尽管本研究在证明异丙酚的有效性和安全性方面存在不足之处,但双频指数监测下的异丙酚镇静可改善内镜黏膜下剥离术后的康复情况。

     


    Propofol sedation with bispectral index monitoring is useful for endoscopic submucosal dissection: a randomized prospective phase II clinical trial

    T. Sasaki, S. Tanabe, M. Azuma, A. Sato, A. Naruke, K. Ishido, C. Katada, K. Higuchi, W. Koizumi

    Department of Gastroenterology, KitasatoUniversitySchoolof Medicine,Kanagawa,Japan

    Background and study aims: Endoscopic submucosal dissection (ESD) has become a standard treatment. However, the treatment time tends to be relatively long and insufflation and manipulation of the endoscope can increase pain and discomfort. We aimed to find an optimal method for sedation during ESD.

    Patients and methods: Patients scheduled to undergo ESD for early gastric cancer or adenoma were randomly assigned to sedation with midazolam or propofol, and consciousness level was evaluated by bispectral index (BIS) monitoring. Primary end points of effectiveness (three parameters) and secondary end points of safety during ESD and after return to the ward were compared between the groups. Study registration was in the UMIN Clinical Trial Registry (UMIN 000001497), and the institutional trial number was KDOG 0801.

    Results: From June 2008 through June 2009, we enrolled 178 patients (90 midazolam, 88 propofol). Regarding safety after ESD, recovery was significantly better in the propofol group immediately after and at 1 hour and 2 hours after return to the ward (P < 0.001). The number of patients who required a continuous supply of oxygen 2 hours after returning to the ward was significantly lower in the propofol group (midazolam 18; propofol 6; P = 0.010). Though propofol seemed to be better for effectiveness and safety, there were no statistically significant differences for all three primary end points and the safety parameters (hypotension, hypoxia, bradycardia).

    Conclusions: Propofol with BIS monitoring improved recovery of patients after ESD, though this study was underpowered to prove the effectiveness and safety of propofol.

     

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