Reletex Versus Standard of Care Therapy for Post-Operative Nausea Control in Patients Undergoing Foregut Surgery (Reletex)

• ClinicalTrials.gov Identifier: NCT01510379
• Recruitment Status: Completed
• First Posted: January 16, 2012
• Results First Posted: March 5, 2014
• Last Update Posted: March 5, 2014
• Sponsor: Kyle A Perry
• Information provided by (Responsible Party): Kyle A Perry, Ohio State University

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.

Condition or disease	Intervention/treatment	Phase
Nausea and Vomiting Post-foregut Surgery	Device: Reletex; Drug: 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	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• 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 Start Date: August 2011
• Actual Primary Completion Date: July 2012
• Actual Study Completion Date: August 2012

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: 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.	Device: Reletex; Neurostimulation device for prevention/treatment of post-operative nausea and vomiting, Reletex arm.; Drug: 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
Control; 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.	Device: Reletex; Neurostimulation device for prevention/treatment of post-operative nausea and vomiting, Reletex arm.; Drug: 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

Outcome Measures

Primary Outcome Measures :

1. Comparison of Postoperative Nausea and Vomiting Scores Between Groups Treated With a ReletexTM Device and Those Without the Device. [ Time Frame: 24 hours ]
   Post-operative Nausea and Vomiting (PONV) Likert scale, 0-10 (0=no PONV, 10=worst PONV).

Secondary Outcome Measures :

1. Quantify the Amounts of Phenergan Used Between the Two Groups. [ Time Frame: one week ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 85 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Ohio

The Ohio State University Medical Center

Columbus, Ohio, United States, 43210

Sponsors and Collaborators

Kyle A Perry

Investigators

• Principal Investigator: Kyle Perry, MD; Ohio State University

More Information

• Responsible Party: Kyle A Perry, Assistant Professor General Surgery 614-293-5815, Ohio State University
• ClinicalTrials.gov Identifier: NCT01510379
• Other Study ID Numbers: 2011H0236
• First Posted: January 16, 2012
• Results First Posted: March 5, 2014
• Last Update Posted: March 5, 2014
• Last Verified: January 2014

Keywords provided by Kyle A Perry, Ohio State University:

nausea; vomiting; post-operative; foregut surgery

Additional relevant MeSH terms:

Nausea; Vomiting; Postoperative Nausea and Vomiting; Signs and Symptoms, Digestive; Postoperative Complications; Pathologic Processes; Promethazine; Diphenhydramine; Ondansetron; Antiemetics; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Gastrointestinal Agents; Antipruritics; Dermatologic Agents; Serotonin Antagonists; Serotonin Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Antipsychotic Agents; Tranquilizing Agents; Central Nervous System Depressants; Psychotropic Drugs; Anti-Anxiety Agents; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Anti-Allergic Agents; Sleep Aids, Pharmaceutical