The Ohio State University Medical Center
Columbus, Ohio, 43210, United States
NCT Number: NCT01510379
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.
Looking for future studies?
Notify Me18 year–85 year
All sexes
Interventional
Not applicable
Columbus, Ohio, 43210, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Neurostimulation device for prevention/treatment of post-operative nausea and vomiting, Reletex arm.
Time frame: 24 hours
Post-operative Nausea and Vomiting (PONV) Likert scale, 0-10 (0=no PONV, 10=worst PONV).
Time frame: one week
Kyle A Perry
Other
Median Nerve Acustimulation Plus Medical Anti-emetic Therapy for Control Post-operative Nausea in Patients Undergoing Foregut Surgery: A Randomized Control Trial
Acronym: Reletex
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05676294
Nausea, Pathologic Processes
New Haven, Connecticut, United States
View Trial DetailsNCT06899217
Abdominal Pain, Digestive System Diseases
Birmingham, Alabama, United States
View Trial DetailsNCT07038551
Constipation, Nausea
Toyohashi, Aichi-ken, Japan
View Trial DetailsNCT07403370
Nausea, Nausea and Vomiting
Jinan, Shandong, China
View Trial Details