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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reletex | Active Comparator | Reletex plus scheduled IV ondansetron 4 mg q 6 hours for a total of 4 doses. Breakthrough nausea will be treated using IV promethazine 25 mg q 6 hours prn during the hospital stay and in elixir at the same dose and frequency after discharge. |
|
| Control | Other | Scheduled IV ondansetron 4 mg q 6 hours for a total of 4 doses. Breakthrough nausea will be treated using IV promethazine 25 mg q 6 hours prn during the hospital stay and in elixir at the same dose and frequency after discharge. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reletex | Device | Neurostimulation device for prevention/treatment of post-operative nausea and vomiting, Reletex arm. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Quantify the Amounts of Phenergan Used Between the Two Groups. | one week |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kyle Perry, MD | Ohio State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ohio State University Medical Center | Columbus | Ohio | 43210 | United States |
Enrolled participants were not excluded from the trial before assignment to groups.
Recruitment occurred at The Ohio State University Wexner Medical Center over a 1 year period.
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| ID | Title | Description |
|---|---|---|
| FG000 | Reletex | Reletex plus scheduled IV ondansetron 4 mg q 6 hours for a total of 4 doses. Breakthrough nausea will be treated using IV promethazine 25 mg q 6 hours prn during the hospital stay and in elixir at the same dose and frequency after discharge. |
| FG001 | Control |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| 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 |
|
Scheduled IV ondansetron 4 mg q 6 hours for a total of 4 doses. Breakthrough nausea will be treated using IV promethazine 25 mg q 6 hours prn during the hospital stay and in elixir at the same dose and frequency after discharge. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Reletex | Reletex plus scheduled ondansetron and phenergan prn |
| BG001 | Control | Scheduled ondansetron plus phenergan prn |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Posted | Mean | Standard Deviation | units on a scale | 24 hours |
|
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| |||||||||||||||||||||||||||||
| Secondary | Quantify the Amounts of Phenergan Used Between the Two Groups. | Posted | Mean | Standard Deviation | mg | one week |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Reletex | Reletex plus scheduled ondansetron and phenergan prn | 0 | 49 | 0 | 49 | ||
| EG001 | Control | Scheduled ondansetron plus phenergan prn | 0 | 51 | 0 | 51 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kyle A. Perry, MD | The Ohio State University | 614-293-5815 | kyle.perry@osumc.edu |
| ID | Term |
|---|---|
| D009325 | Nausea |
| D014839 | Vomiting |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D017294 | Ondansetron |
| D011398 | Promethazine |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D002227 | Carbazoles |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D010640 | Phenothiazines |
| D013457 | Sulfur Compounds |
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| >=65 years |
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| Male |
|
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