Nausea and Vomiting Post-foregut Surgery
Conditions
Keywords
nausea, vomiting, post-operative, foregut surgery
Brief 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.
Interventions
DEVICEReletex
Neurostimulation device for prevention/treatment of post-operative nausea and vomiting, Reletex arm.
DRUGIV ondansetron 4 mg q 6 hours for a total of 4 doses
DRUGIV promethazine 25 mg q 6 hours prn
DRUGElixir promethazine 25 mg q 6 hours prn after discharge
Sponsors
Kyle A Perry
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Age 18-85 * Planned fundoplication * Willingness to comply with randomization and follow-up protocol * English speaking
Exclusion criteria
* \< 18 years of age or \> 85 * Chronic nausea requiring medical treatment * Planned concomitant procedures * Pacemaker or automatic internal cardiac defibrillator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of Postoperative Nausea and Vomiting Scores Between Groups Treated With a ReletexTM Device and Those Without the Device. | 24 hours | Post-operative Nausea and Vomiting (PONV) Likert scale, 0-10 (0=no PONV, 10=worst PONV). |
Secondary
| Measure | Time frame |
|---|---|
| Quantify the Amounts of Phenergan Used Between the Two Groups. | one week |
Countries
United States
Participant flow
Recruitment details
Recruitment occurred at The Ohio State University Wexner Medical Center over a 1 year period.
Pre-assignment details
Enrolled participants were not excluded from the trial before assignment to groups.
Participants by arm
| Arm | Count |
|---|---|
| Reletex Reletex plus scheduled ondansetron and phenergan prn | 49 |
| Control Scheduled ondansetron plus phenergan prn | 51 |
| Total | 100 |
Baseline characteristics
| Characteristic | Control | Reletex | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 15 Participants | 11 Participants | 26 Participants |
| Age, Categorical Between 18 and 65 years | 36 Participants | 38 Participants | 74 Participants |
| Age, Continuous | 58 years STANDARD_DEVIATION 16.16 | 57 years STANDARD_DEVIATION 14.22 | 57 years STANDARD_DEVIATION 15.17 |
| Region of Enrollment United States | 51 participants | 49 participants | 100 participants |
| Sex: Female, Male Female | 34 Participants | 35 Participants | 69 Participants |
| Sex: Female, Male Male | 17 Participants | 14 Participants | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 49 | 0 / 51 |
| serious Total, serious adverse events | 0 / 49 | 0 / 51 |
Outcome results
Primary
Comparison of Postoperative Nausea and Vomiting Scores Between Groups Treated With a ReletexTM Device and Those Without the Device.
Post-operative Nausea and Vomiting (PONV) Likert scale, 0-10 (0=no PONV, 10=worst PONV).
Time frame: 24 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Reletex | Comparison of Postoperative Nausea and Vomiting Scores Between Groups Treated With a ReletexTM Device and Those Without the Device. | 1.81 units on a scale | Standard Deviation 2.17 |
| Control | Comparison of Postoperative Nausea and Vomiting Scores Between Groups Treated With a ReletexTM Device and Those Without the Device. | 2.03 units on a scale | Standard Deviation 2.83 |
Secondary
Quantify the Amounts of Phenergan Used Between the Two Groups.
Time frame: one week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Reletex | Quantify the Amounts of Phenergan Used Between the Two Groups. | 42 mg | Standard Deviation 75.6 |
| Control | Quantify the Amounts of Phenergan Used Between the Two Groups. | 57.6 mg | Standard Deviation 128.2 |