首个计算机辅助丙泊酚镇静的美国临床经验:疗效、安全性、效率和内镜医师及患者满意度的回顾性观察比较研究

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The First US Clinical Experience With Computer-Assisted Propofol Sedation: A Retrospective Observational Comparative Study on Effcacy, Safety, Effciency, and Endoscopist and Patient Satisfaction

背景与目的

计算机辅助丙泊酚镇静剂(CAPS)现已被批准用于美国麻醉医师学会(ASA)I级和II级患者进行常规内窥镜检查时的中度镇静。作为第一个采用CAPS进行常规临床应用的美国医疗中心,我们比较了使用CAPS与咪达唑仑、芬太尼(MF)镇静合剂的患者和内窥镜医师的满意度。

方  法

把使用CAPS的择期门诊上消化内镜和结肠镜检查的患者与使用MF镇静的患者相比较。主要结局是患者的满意度(通过已验证的患者镇静满意度指数[PSSI]测量)和内窥镜医师的满意度(临床医生镇静满意度指数[CSSI]))。次要结局包括操作的成功率、息肉检出率、不良事件和手术/恢复时间。比较采用多变量回归分析。

结  果

244例患者采用CAPS进行镇静,其中55例接受上消化道内镜检查,173例接受结肠镜检查,16例进行两种检查。在同一时期,对类似的患者采用MF进行了75例上消化道内镜检查,223例结肠镜检查和30例二种检查。对于上消化道内镜检查,CAPS的手术成功率为98.2%,MF为98.7%(P = .96),而结肠镜检查成功率为98.9%,而98.8%(P = .59)。CAPS的结肠息肉检出率为54.5%,MF为59.3%(P = .67)。CAPS和MF之间的操作时间相似。CAPS与MF的平均恢复时间为26.4 vs 39.1分钟(P <0.001)。一名CAPS患者需要面罩通气,4名发生无症状低血压或血氧饱和度降低,5名患者发生血压过低引起的明显兴奋。对于MF,5名患者有低血压或血氧饱和度降低,8名患有低血压。对于结肠镜检查,CAPS组具有较高的镇静适应度、恢复过程和总体满意度的PSSI评分,以及CSSI评分较高,易于镇静管理、恢复和具有较高的总体满意度。对于上消化道内窥镜检查和二种检查,CAPS的CSSI评分仅在恢复过程中较高。通过回归分析对所有P值进行校对。

结  论

CAPS似乎对低危患者更高效。CAPS在结肠镜检查中比MF的满意度较高,而与上消化道内镜检查相关性较低。

原始文献摘要

Lin OS, Kozarek RA, Tombs D, La Selva D, Weigel W, Beecher R, Jensen A, Gluck M, Ross A.The First US Clinical Experience With Computer-Assisted Propofol Sedation: A Retrospective Observational Comparative Study on Efficacy, Safety, Efficiency, and Endoscopist and Patient Satisfaction.Anesth Analg. 2017 Sep;125(3):804-811. 

BACKGROUND:Computer-assisted propofol sedation (CAPS) is now approved for moderate sedation of American Society of Anesthesiologists (ASA) class I and II patients undergoing routine endoscopy. As

the first US medical center to adopt CAPS for routine clinical use, we compared patient and endoscopist satisfaction with CAPS versus midazolam and fentanyl (MF) sedation.

METHODS:Patients who underwent elective outpatient upper endoscopy and colonoscopy with CAPS were compared with concurrent patients sedated with MF. The primary end points

were patient satisfaction (measured by the validated Patient Sedation Satisfaction Index [PSSI]), and endoscopist satisfaction (Clinician Sedation Satisfaction Index [CSSI]). Secondary end points included procedural success rates, polyp detection rates, adverse events, and procedure/recovery times. Multivariable regression was used for comparative analysis.

RESULTS:CAPS was utilized to sedate 244 patients, of whom 55 underwent upper endoscopy, 173 colonoscopy, and 16 double procedures. During the same period, 75 upper endoscopies, 223 colonoscopies, and 30 doubles were performed with MF on similar patients. For upper endoscopy, the procedural success rate was 98.2% for CAPS versus 98.7% for MF (P = .96), whereas for colonoscopy, the success rate was 98.9% vs 98.8% (P = .59). Colonoscopic polyp detection rate was 54.5% for CAPS and 59.3% for MF (P = .67). Procedure times were similar between CAPS and MF. For CAPS, the mean recovery time was 26.4 vs 39.1 minutes for MF (P < .001). One CAPS patient required mask ventilation, 4 experienced asymptomatic hypotension or desaturation, and 5 experienced marked agitation resulting from undersedation. For MF, 5 patients had hypotension or desaturation, and 8 experienced undersedation. For colonoscopy, the CAPS group had higher PSSI scores for sedation adequacy, the recovery process and global satisfaction, and higher CSSI scores for ease of sedation administration, the recovery process and global satisfaction. For upper endoscopy and doubles, the CAPS CSSI score was higher for the recovery process only. All P values were adjusted for confounding by using regression analysis.

CONCLUSIONS:In low-risk patients, CAPS appears to be effective and efficient. CAPS is associated with higher satisfaction than MF for colonoscopies and, to a lesser extent, upper endoscopies.

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