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

NCT ID: NCT01510379

Last Updated: 2014-03-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2012-08-31

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.

Conditions

Nausea and Vomiting Post-foregut Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Reletex

Intervention Type: DEVICE

Neurostimulation device for prevention/treatment of post-operative nausea and vomiting, Reletex arm.

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

Intervention Type: DRUG

IV promethazine 25 mg q 6 hours prn

Intervention Type: DRUG

Elixir promethazine 25 mg q 6 hours prn after discharge

Intervention Type: DRUG

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.

Group Type: OTHER

Reletex

Intervention Type: DEVICE

Neurostimulation device for prevention/treatment of post-operative nausea and vomiting, Reletex arm.

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

Intervention Type: DRUG

IV promethazine 25 mg q 6 hours prn

Intervention Type: DRUG

Elixir promethazine 25 mg q 6 hours prn after discharge

Intervention Type: DRUG

Interventions

Reletex

Neurostimulation device for prevention/treatment of post-operative nausea and vomiting, Reletex arm.

Intervention Type: DEVICE

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

Intervention Type: DRUG

IV promethazine 25 mg q 6 hours prn

Intervention Type: DRUG

Elixir promethazine 25 mg q 6 hours prn after discharge

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kyle A Perry

OTHER

Sponsor Role: lead

Responsible Party

Kyle A Perry

Assistant Professor General Surgery 614-293-5815

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Kyle Perry, MD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

The Ohio State University Medical Center

Columbus, Ohio, United States

Countries

United States

Other Identifiers

2011H0236

Identifier Type: -

Identifier Source: org_study_id