Metoclopramide Versus Placebo for GJ Placement

• Status: Completed
• Trial end date: 2019-10-03
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Duke University
• Treatments: Metoclopramide

Criteria

Inclusion Criteria:

• 18 years old or older

• undergoing de novo GJ placement as part of their routine clinical care

Exclusion Criteria:

• Patient pregnant

• Contraindications to metoclopramide including:

• allergic reaction

• pheochromocytoma

• QTc prolongation

• history of seizure disorder

• extrapyramidal symptoms