N/A
N=100
Reletex Versus Standard of Care Therapy for Post-Operative Nausea Control in Patients Undergoing Foregut Surgery
Nausea and Vomiting Post-foregut Surgery
Bottom Line
View on ClinicalTrials.gov: NCT01510379 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Mar 2014
Primary outcome: Primary: Comparison of Postoperative Nausea and Vomiting Scores Between Groups Treated With a ReletexTM Device and Those Without the Device. — 1.81; 2.03 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Reletex (Device); IV ondansetron 4 mg q 6 hours for a total of 4 doses (Drug); IV promethazine 25 mg q 6 hours prn (Drug); Elixir promethazine 25 mg q 6 hours prn after discharge (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Kyle A Perry
- Primary completion
- Jul 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Comparison of Postoperative Nausea and Vomiting Scores Between Groups Treated With a ReletexTM Device and Those Without the Device. |
1.81; 2.03 | — |
| SECONDARY Quantify the Amounts of Phenergan Used Between the Two Groups. |
42; 57.6 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Age 18-85
- Planned fundoplication
- Willingness to comply with randomization and follow-up protocol
- English speaking
Exclusion Criteria
- 85
- Chronic nausea requiring medical treatment
- Planned concomitant procedures
- Pacemaker or automatic internal cardiac defibrillator
Data sourced from ClinicalTrials.gov (NCT01510379). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.