MedTrace Logo

Metoclopramide Versus Placebo for GJ Placement

NCT03331965 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2020-07-13

Study results available
· View outcomes & findings →

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.

Conditions

  • Radiation Exposure
  • Enteral Nutrition

Interventions

DRUG

Metoclopramide 5 MG/ML Injectable Solution

A one-time dose of promotility agent (metoclopramide 10 mg in 10 mL saline IV) will be administered at the time of GJ placement.

DRUG

Saline

A one-time dose of a placebo (10 mL saline IV) will be administered at the time of GJ placement.

Sponsors & Collaborators

Principal Investigators

  • James Ronald · Medical Instructor, Vascular & Interventional Radiology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-09
Primary Completion
2019-10-03
Completion
2019-10-03
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03331965 on ClinicalTrials.gov