Reletex Versus Standard of Care Therapy for Post-Operative Nausea Control in Patients Undergoing Foregut Surgery (Reletex)
Primary Purpose
Nausea and Vomiting Post-foregut Surgery
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Reletex
IV ondansetron 4 mg q 6 hours for a total of 4 doses
IV promethazine 25 mg q 6 hours prn
Elixir promethazine 25 mg q 6 hours prn after discharge
Sponsored by
About this trial
This is an interventional prevention trial for Nausea and Vomiting Post-foregut Surgery focused on measuring nausea, vomiting, post-operative, foregut surgery
Eligibility Criteria
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
Sites / Locations
- The Ohio State University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Other
Arm Label
Reletex
Control
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Quantify the Amounts of Phenergan Used Between the Two Groups.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01510379
Brief Title
Reletex Versus Standard of Care Therapy for Post-Operative Nausea Control in Patients Undergoing Foregut Surgery
Acronym
Reletex
Official Title
Median Nerve Acustimulation Plus Medical Anti-emetic Therapy for Control Post-operative Nausea in Patients Undergoing Foregut Surgery: A Randomized Control Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
August 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Kyle A Perry
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nausea and Vomiting Post-foregut Surgery
Keywords
nausea, vomiting, post-operative, foregut surgery
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Reletex
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control
Arm Type
Other
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Reletex
Intervention Description
Neurostimulation device for prevention/treatment of post-operative nausea and vomiting, Reletex arm.
Intervention Type
Drug
Intervention Name(s)
IV ondansetron 4 mg q 6 hours for a total of 4 doses
Intervention Type
Drug
Intervention Name(s)
IV promethazine 25 mg q 6 hours prn
Intervention Type
Drug
Intervention Name(s)
Elixir promethazine 25 mg q 6 hours prn after discharge
Primary Outcome Measure Information:
Title
Comparison of Postoperative Nausea and Vomiting Scores Between Groups Treated With a ReletexTM Device and Those Without the Device.
Description
Post-operative Nausea and Vomiting (PONV) Likert scale, 0-10 (0=no PONV, 10=worst PONV).
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Quantify the Amounts of Phenergan Used Between the Two Groups.
Time Frame
one week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyle Perry, MD
Organizational Affiliation
Ohio State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Ohio State University Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Reletex Versus Standard of Care Therapy for Post-Operative Nausea Control in Patients Undergoing Foregut Surgery
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