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一项随机对照试验,旨在确认水法对接受按需镇静的美国退伍军人行结肠镜检查的有益效果。

A randomized, controlled trial to confirm the beneficial effects of the water method on U.S. veterans undergoing colonoscopy with the option of on-demand sedation.

机构信息

Gastroenterology, University of California Davis Medical Center, Sacramento, USA.

出版信息

Gastrointest Endosc. 2011 Jan;73(1):103-10. doi: 10.1016/j.gie.2010.09.020.

DOI:10.1016/j.gie.2010.09.020
PMID:21184876
Abstract

BACKGROUND

Sedation for colonoscopy discomfort imposes a recovery-time burden on patients. The water method permitted 52% of patients accepting on-demand sedation to complete colonoscopy without sedation. On-site and at-home recovery times were not reported.

OBJECTIVE

To confirm the beneficial effect of the water method and document the patient recovery-time burden.

DESIGN

Randomized, controlled trial, with single-blinded, intent-to-treat analysis.

SETTING

Veterans Affairs outpatient endoscopy unit.

PATIENTS

This study involved veterans accepting on-demand sedation for screening and surveillance colonoscopy.

INTERVENTION

Air versus water method for colonoscope insertion.

MAIN OUTCOME MEASUREMENTS

Proportion of patients completing colonoscopy without sedation, cecal intubation rate, medication requirement, maximum discomfort (0 = none, 10 = severe), procedure-related and patient-related outcomes.

RESULTS

One hundred veterans were randomized to the air (n = 50) or water (n = 50) method. The proportions of patients who could complete colonoscopy without sedation in the water group (78%) and the air group (54%) were significantly different (P = .011, Fisher exact test), but the cecal intubation rate was similar (100% in both groups). Secondary analysis (data as Mean [SD]) shows that the water method produced a reduction in medication requirement: fentanyl, 12.5 (26.8) μg versus 24.0 (30.7) μg; midazolam, 0.5 (1.1) mg versus 0.94 (1.20) mg; maximum discomfort, 2.3 (1.7) versus 4.9 (2.0); recovery time on site, 8.4 (6.8) versus 12.3 (9.4) minutes; and recovery time at home, 4.5 (9.2) versus 10.9 (14.0) hours (P = .049; P = .06; P = .0012; P = .0199; and P = .0048, respectively, t test).

LIMITATIONS

Single Veterans Affairs site, predominantly male population, unblinded examiners.

CONCLUSION

This randomized, controlled trial confirms the reported beneficial effects of the water method. The combination of the water method with on-demand sedation minimizes the patient recovery-time burden. (

CLINICAL TRIAL REGISTRATION NUMBER

NCT00920751.).

摘要

背景

结肠镜检查不适时的镇静会给患者带来恢复时间的负担。水法允许 52%接受按需镇静的患者无需镇静即可完成结肠镜检查。未报告现场和家庭恢复时间。

目的

确认水法的有益效果,并记录患者的恢复时间负担。

设计

随机对照试验,单盲,意向治疗分析。

地点

退伍军人事务部门诊内镜单位。

患者

本研究涉及接受按需镇静进行筛查和监测结肠镜检查的退伍军人。

干预措施

用于结肠镜插入的空气与水方法。

主要观察指标

无需镇静即可完成结肠镜检查的患者比例、盲肠插管率、药物需求、最大不适(0 = 无,10 = 严重)、与程序相关和与患者相关的结果。

结果

100 名退伍军人被随机分配到空气(n = 50)或水(n = 50)组。水组(78%)和空气组(54%)无需镇静即可完成结肠镜检查的患者比例有显著差异(P =.011,Fisher 确切检验),但盲肠插管率相似(两组均为 100%)。二次分析(数据为平均值[标准差])显示,水法减少了药物需求:芬太尼 12.5(26.8)μg 与 24.0(30.7)μg;咪达唑仑 0.5(1.1)mg 与 0.94(1.20)mg;最大不适 2.3(1.7)与 4.9(2.0);现场恢复时间 8.4(6.8)与 12.3(9.4)分钟;家庭恢复时间 4.5(9.2)与 10.9(14.0)小时(P =.049;P =.06;P =.0012;P =.0199;P =.0048,分别为 t 检验)。

局限性

单一退伍军人事务网站,主要为男性人群,检查者未设盲。

结论

这项随机对照试验证实了水法的报道效果。水法与按需镇静相结合,最大限度地减少了患者的恢复时间负担。(临床研究登记号:NCT00920751。)

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