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Prospective Long-Term Assessment of Sedation-Related Adverse Events and Patient Satisfaction for Upper Endoscopy and Colonoscopy

机译:镇静相关不良事件的前瞻性长期评估以及上内镜和结肠镜检查的患者满意度

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Background: Fear of pain and sedation-related adverse events are impediments for patients to attend endoscopic screening or surveillance programs. Objective: To investigate the long-term effect of different sedation protocols in patients undergoing screening or surveillance endoscopy. Moreover, motivation of patients to decline endoscopic procedures was evaluated by focusing on the patient's satisfaction, fear and pain in relation to type of sedation used. Methods: Design: A prospective, double-blind controlled trial data collection was performed by using a standardized clinical questionnaire followed by a telephone interview 3-4 weeks after the initial endoscopic procedure. Setting: The study was conducted at the Department of Medicine I at the University Hospital of Erlangen-Nuremberg. Data collection was performed during June 2012 till April 2013. Patients: Overall, 307 patients were prospectively evaluated (44.3% female, mean age 51 ± 17.4 years; mean BMI 25.5 ± 5.7). 247 patients (80.5%) were outpatients, 60 inpatients (19.5%). Interventions: Endoscopic procedures were divided into five groups: (i) procedures in the upper gastrointestinal tract, (ii) complete colonoscopies, (iii) ileocolonoscopies, (iv) incomplete colonoscopies, and (v) other procedures. Main outcome measurements: Patient satisfaction, fear and pain were measured in a structured and standardized clinical interview using a 6-point numerical rating scale, where 1 was 'very satisfiedo pain' and 6 was 'very unsatisfied/unsupportable pain'. Results: Different types of sedation were assessed: propofol in monosedation (6.5%), combination of propofol + meperidine (41.0%), combination of midazolam + meperidine (48.5%) and other combinations (3.9%). Patient satisfaction was significantly reduced regarding fear and pain during the endoscopic procedure (p = 0.001 and p = 0.0001, respectively). All patients receiving propofol monosedation indicated significantly less pain in comparison to other sedation groups (p < 0.0001). Moreover, sedation with midazolam + meperidine increased the fear during the procedure significantly in comparison to monosedation with propofol (p = 0.082). Propofol/meperidine in combination and midazolam/meperidine increased the probability for cardiovascular events in comparison to monosedation with propofol (p = 0.005; p = 0.039). Finally, we observed significantly lower doses of propofol when used in monosedation than propofol in combination with meperidine (p = 0.066). Limitation: Single-center study at a tertiary referral center. Conclusions: Propofol in monosedation should preferably be used for patient sedation in screening and surveillance endoscopies. Whether this approach could also improve participation rates in screening and surveillance endoscopies requires further investigations.
机译:背景:担心疼痛和与镇静有关的不良事件是患者参加内窥镜检查或监视程序的障碍。目的:研究不同镇静方案对接受筛查或监测内窥镜检查的患者的长期效果。此外,通过关注与所用镇静剂类型有关的患者满意度,恐惧和疼痛来评估患者拒绝内镜手术的动机。方法:设计:采用标准化的临床调查表进行前瞻性,双盲对照试验数据收集,然后在初始内镜手术后3-4周进行电话采访。地点:该研究在埃尔兰根-纽伦堡大学医院的第一医学科进行。数据收集于2012年6月至2013年4月进行。患者:总共对307例患者进行了前瞻性评估(女性44.3%,平均年龄51±17.4岁;平均BMI 25.5±5.7)。门诊患者247例(80.5%),住院患者60例(19.5%)。干预措施:内窥镜检查程序分为五组:(i)上消化道检查程序;(ii)完全结肠镜检查;(iii)回肠结肠镜检查;(iv)不完全结肠镜检查;以及(v)其他程序。主要结果测量:使用6点数字评分量表在结构化和标准化的临床访谈中测量患者的满意度,恐惧和疼痛,其中1分表示“非常满意/没有疼痛”,而6分表示“非常不满意/无法承受的疼痛”。结果:评估了不同类型的镇静作用:单镇静的异丙酚(6.5%),丙泊酚+哌替啶的组合(41.0%),咪达唑仑+哌替啶的组合(48.5%)和其他组合(3.9%)。在内窥镜检查过程中,由于恐惧和疼痛,患者满意度显着降低(分别为p = 0.001和p = 0.0001)。与其他镇静组相比,接受丙泊酚单镇静的所有患者均显示疼痛明显减轻(p <0.0001)。此外,与丙泊酚单药镇静相比,使用咪达唑仑+甲哌丁啶镇静会明显增加手术过程中的恐惧感(p = 0.082)。与丙泊酚单药镇静相比,丙泊酚/哌啶和咪达唑仑/甲哌啶的组合增加了发生心血管事件的可能性(p = 0.005; p = 0.039)。最后,我们观察到用于单镇静的丙泊酚的剂量明显低于丙泊酚与哌替啶的组合剂量(p = 0.066)。局限性:三级转诊中心的单中心研究。结论:安乐死的丙泊酚应优选用于筛查和监测内镜检查的患者镇静。这种方法是否还可以提高筛查和监测内镜检查的参与率,还需要进一步研究。

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