100
Participants
Start Date
July 31, 2025
Primary Completion Date
July 31, 2026
Study Completion Date
July 31, 2026
Wearable Transcutaneous electrical Nerve Stimulation unit to mitigate postoperative nausea and vomiting (PONV) in the Bariatric Surgical Patient
Use of a wearable device, which emits a low-level electric current across 2 small electrodes on the underside of the patient's wrist, stimulating the nerves and sending a signal to the center of the brain that can help suppress nausea/vomiting. A review of the medical literature found studies that found the device to be effective in reducing PONV. It has been studied in the past, but the trials had limitations, not double blinded and no true placebo. We have proposed a true double blind randomized study utilizing a placebo which specifically mimics the actual device as closely as possible to prevent bias and adversely effecting data results. Nor had this device been tested specifically in the postop bariatric surgical patient.
A sham device that will mimic the active wearable device. It will look the same, and buzz but will not actually admit a low-leve electric current that would stimulate the nerves.
The company who makes the active device created a sham wearable device that looks like the active, and buzzes (to give the feel of stimulation), but does not actual emit a low-leve electrical signal to stimulate the nerves.
University of Pennsylvania
OTHER