Reletex Versus Standard of Care Therapy for Post-Operative Nausea Control in Patients Undergoing Foregut Surgery
Completed · Not applicable
Conditions studied: Nausea and Vomiting Post-foregut Surgery
In brief
The effect a ReletexTM device has on postoperative nausea and vomiting when used with ondansetron after foregut surgery will be studied. A ReletexTM device is a FDA approved wristwatch-like device that painlessly stimulates a nerve in the wrist and has been shown to decrease nausea and vomiting. The investigators will randomize 100 patients who are having a fundoplication for either gastroesophageal reflux disease (GERD), paraesophageal hernia, or Heller Myotomy for achalasia into two groups. A control group will receive scheduled ondansetron for prevention and treatment of postoperative nausea and vomiting and phenergan as needed. The treatment group will wear a ReletexTM wrist band after surgery for 7 days. These patients will also get scheduled ondansetron and phenergan as needed, like the control group. The investigators will compare nausea, retching, and the amount of supplemental nausea medication used between the two groups. The patients will be provided a diary to document their nausea, retching, and medication use. The hypothesis of this study is that use of the ReletexTM device will reduce post-operative nausea and vomiting, and will reduce post-operative use of anti-emetic medications in patients who have undergone foregut surgery.
Key facts
- Study ID
- NCT01510379
- Run by
- Kyle A Perry
- People needed
- 100
- Starts
- 2011-08-01
- Expected to finish
- 2012-08-01
- Last updated by the study team
- 2014-03-05
Who can join
Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age 18-85
- Planned fundoplication
- Willingness to comply with randomization and follow-up protocol
- English speaking
You may not qualify if…
- < 18 years of age or > 85
- Chronic nausea requiring medical treatment
- Planned concomitant procedures
- Pacemaker or automatic internal cardiac defibrillator
Where it is running
- The Ohio State University Medical Center — Columbus, Ohio, United States
Full record on ClinicalTrials.gov
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