Metoclopramide Versus Placebo for GJ Placement
Completed · Phase 2 · Has a placebo group
Conditions studied: Radiation Exposure, Enteral Nutrition
In brief
The goal of this study is to determine whether use of promotility agents to stimulate gastric peristalsis can reduce fluoroscopy time and procedure time during gastrojejunostomy (GJ) tubes placement in interventional radiology (IR). The investigators hypothesize that increased gastric peristalsis will aid in advancing a guidewire through the pylorus, a time consuming and tedious step required during GJ tube placement. In order to maximize scientific rigor and clinical practice impact, the investigators aim to answer this question through a blinded, randomized, placebo controlled trial. Specific Aim 1: To test the hypothesis that a single dose of IV metoclopramide immediately prior to GJ tube placement reduces the fluoroscopy time required to advance a guidewire through the pylorus. Specific Aim 2: To determine whether a single dose of IV metoclopramide immediately prior to GJ tube placement reduces total procedure fluoroscopy time, air kerma and total procedure time. Specific Aim 3: To assess the safety of a single dose of promotility agent prior to GJ tube placement by assessing rates of adverse events in the periprocedural period in patients receiving IV metoclopramide versus placebo.
Key facts
- Study ID
- NCT03331965
- Run by
- Duke University
- People needed
- 110
- Starts
- 2018-04-09
- Expected to finish
- 2019-10-03
- Last updated by the study team
- 2020-07-13
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 18 years old or older
- undergoing de novo GJ placement as part of their routine clinical care
You may not qualify if…
- Patient pregnant
- Contraindications to metoclopramide including:
- allergic reaction
- pheochromocytoma
- QTc prolongation
- history of seizure disorder
- extrapyramidal symptoms
Where it is running
- Duke University Hospital — Durham, North Carolina, United States
Full record on ClinicalTrials.gov
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