Charlottesville Medical Research and Charlottesville Gastroenterology Associates, 325 Winding River Lane, Suite 102, Charlottesville, VA 22911, USA.
Gastrointest Endosc. 2011 Apr;73(4):765-72. doi: 10.1016/j.gie.2010.10.031. Epub 2010 Dec 18.
The SEDASYS System is an investigational computer-assisted personalized sedation system integrating propofol delivery with patient monitoring to enable endoscopist/nurse teams to safely administer propofol.
To compare the safety and effectiveness of the SEDASYS System to the current standard of care for sedation during routine endoscopic procedures.
Nonblinded multicenter randomized comparative study.
Four ambulatory surgery centers, 3 endoscopy centers, and 1 academic center in the United States.
One thousand American Society of Anesthesiologists physical status class I to III adults undergoing routine colonoscopy or EGD.
Sedation with the SEDASYS System (SED) and sedation with each site's current standard of care (CSC; benzodiazepine/opioid combination).
Area under the curve of oxygen desaturation was the primary endpoint. Secondary endpoints included patient satisfaction, clinician satisfaction, level of sedation, and patient recovery time.
Four hundred ninety-six patients were randomized to SED and 504 to CSC. Area under the curve of oxygen desaturation was significantly lower for SED (23.6 s·%) than for CSC (88.0 s·%; P = .028). Patients were predominately minimally to moderately sedated in both groups. SED patients were significantly more satisfied than CSC patients (P = .007). Clinician satisfaction was greater with SED than with CSC (P < .001). SED patients recovered faster than CSC patients (P < .001). The incidence of adverse events was 5.8% in the SED group and 8.7% in the CSC group.
Nonblinded.
The SEDASYS System could provide endoscopist/nurse teams a safe and effective on-label means to administer propofol to effect minimal to moderate sedation during routine colonoscopy and EGD.
SEDASYS 系统是一种研究性的计算机辅助个性化镇静系统，它将丙泊酚输注与患者监测相结合，使内镜医师/护士团队能够安全地给予丙泊酚。
比较 SEDASYS 系统与常规内镜检查镇静的当前标准护理的安全性和有效性。
非盲多中心随机对照研究。
美国的四个门诊手术中心、三个内镜中心和一个学术中心。
1000 名美国麻醉医师协会身体状况 I 至 III 级的成年人，接受常规结肠镜检查或 EGD。
SEDASYS 系统镇静（SED）和各中心当前标准护理（CSC；苯二氮䓬/阿片类药物联合）镇静。
氧饱和度下降曲线下面积是主要终点。次要终点包括患者满意度、临床医生满意度、镇静水平和患者恢复时间。
496 名患者被随机分配至 SED 组，504 名患者被随机分配至 CSC 组。SED 的氧饱和度下降曲线下面积明显低于 CSC（23.6 s·% 比 88.0 s·%；P =.028）。两组患者的镇静程度均为轻度至中度。SED 组患者明显比 CSC 组患者更满意（P =.007）。SED 组的临床医生满意度明显高于 CSC 组（P <.001）。SED 组患者的恢复速度明显快于 CSC 组（P <.001）。SED 组的不良事件发生率为 5.8%，CSC 组为 8.7%。
非盲。
SEDASYS 系统为内镜医师/护士团队提供了一种安全有效的标签内手段，可在常规结肠镜检查和 EGD 中给予丙泊酚，以实现轻度至中度镇静。
