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

Kyle A Perry

Status: Completed

Conditions: Nausea and Vomiting Post-foregut Surgery

Treatments: Drug: IV promethazine 25 mg q 6 hours prn; Drug: IV ondansetron 4 mg q 6 hours for a total of 4 doses; Drug: Elixir promethazine 25 mg q 6 hours prn after discharge; Device: Reletex

Study type: Interventional

Funder types: Other

Identifiers

NCT01510379

2011H0236

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Reletex

Active Comparator group

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.

Treatment:

Drug: Elixir promethazine 25 mg q 6 hours prn after discharge

Drug: IV promethazine 25 mg q 6 hours prn

Device: Reletex

Drug: IV ondansetron 4 mg q 6 hours for a total of 4 doses

Control

Other group

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.

Treatment:

Drug: Elixir promethazine 25 mg q 6 hours prn after discharge

Drug: IV promethazine 25 mg q 6 hours prn

Device: Reletex

Drug: IV ondansetron 4 mg q 6 hours for a total of 4 doses