Purpose

To determine whether a single 10-mg intravenous dose of the promotility agent metoclopramide reduces the fluoroscopy time, radiation dose, and procedure time required for gastrojejunostomy (GJ) tube placement.

Methods

This prospective, randomized, double-blind, placebo-controlled trial enrolled consecutive patients who underwent primary GJ tube placement at a single institution from April 10, 2018, to October 3, 2019. Exclusion criteria included age less than 18 years, inability to obtain consent, metoclopramide allergy or contraindication, and altered pyloric anatomy. Average fluoroscopy times, radiation doses, and procedure times were compared using t-tests. The full study protocol can be found at www.clinicaltrials.gov (NCT03331965).

Results

Of 110 participants randomized 1:1, 45 received metoclopramide and 51 received placebo and underwent GJ tube placement (38 females and 58 males; mean age, 55 ± 18 years). Demographics of the metoclopramide and placebo groups were similar. The fluoroscopy time required to advance a guide wire through the pylorus averaged 1.6 minutes (range, 0.3–10.1 minutes) in the metoclopramide group versus 4.1 minutes (range, 0.2–27.3 minutes) in the placebo group (P = .002). Total procedure fluoroscopy time averaged 5.8 minutes (range, 1.5–16.2 minutes) for the metoclopramide group versus 8.8 minutes (range, 2.8–29.7 minutes) for the placebo group (P = .002). Air kerma averaged 91 mGy (range, 13–354 mGy) for the metoclopramide group versus 130 mGy (range, 24–525 mGy) for the placebo group (P = .04). Total procedure time averaged 16.4 minutes (range, 8–51 minutes) for the metoclopramide group versus 19.9 minutes (range, 6–53 minutes) for the placebo group (P = .04). There were no drug-related adverse events and no significant differences in procedure-related complications.

Conclusions

A single dose of metoclopramide reduced fluoroscopy time by 34%, radiation dose by 30%, and procedure time by 17% during GJ tube placement.

中文翻译：

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胃复明在胃空肠造口术管置放过程中减少了透视和手术时间：安慰剂对照试验。

目的

为了确定单剂量10 mg静脉注射促进剂甲氧氯普胺是否会减少胃镜空肠吻合术（GJ）管放置所需的荧光检查时间，放射线剂量和手术时间。

方法

这项前瞻性，随机，双盲，安慰剂对照试验纳入了自2018年4月10日至2019年10月3日在单个机构接受原发GJ管放置的连续患者。排除标准包括年龄小于18岁，无法获得同意，甲氧氯普胺过敏或禁忌症，以及幽门解剖改变。使用t-检验比较平均荧光检查时间，放射剂量和手术时间。完整的研究方案可以在www.clinicaltrials.gov（NCT03331965）上找到。

结果

在110名以1：1随机分组的参与者中，有45名接受了甲氧氯普胺治疗，51名接受了安慰剂治疗，并接受了GJ管放置（38名女性和58名男性；平均年龄55±18岁）。胃复安和安慰剂组的人口统计学相似。甲氧氯普胺组的平均透视时间为导丝穿过幽门1.6分钟（0.3-10.1分钟），而安慰剂组为4.1分钟（0.2-27.3分钟）（P  = 0.002）。甲氧氯普胺组的总透视检查时间平均为5.8分钟（1.5-16.2分钟），而安慰剂组平均为8.8分钟（2.8-29.7分钟）（P = 0.002）。甲氧氯普胺组的空气比释动能平均为91 mGy（范围为13–354 mGy），而安慰剂组为130 mGy（范围为24–525 mGy）（P = .04）。甲氧氯普胺组的平均总手术时间为16.4分钟（8-51分钟），而安慰剂组为19.9分钟（6-53分钟）（P = .04）。没有药物相关的不良事件，与手术相关的并发症也没有显着差异。

结论

在GJ管放置过程中，单剂甲氧氯普胺可将透视时间减少34％，放射线剂量减少30％，手术时间减少17％。