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

NCT01510379 | Completed Results

• 1 other identifier: 2011H0236
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

nausea; vomiting; post-operative; foregut surgery

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Quantify the Amounts of Phenergan Used Between the Two Groups.

  one week

Study Arms (2)

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.

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

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.

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

Interventions

Reletex DEVICE

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

Control; Reletex

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

Control; Reletex

IV promethazine 25 mg q 6 hours prn DRUG

Control; Reletex

Elixir promethazine 25 mg q 6 hours prn after discharge DRUG

Control; Reletex

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-85
• Planned fundoplication
• Willingness to comply with randomization and follow-up protocol
• English speaking

You may not qualify if:

• \< 18 years of age or \> 85
• Chronic nausea requiring medical treatment
• Planned concomitant procedures
• Pacemaker or automatic internal cardiac defibrillator

Sponsors & Collaborators

• Kyle A Perry: lead

Study Sites (1)

The Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Nausea; Vomiting

Interventions

Ondansetron; Promethazine

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring; Propylamines; Amines; Organic Chemicals; Phenothiazines; Sulfur Compounds

Results Point of Contact

• Title: Kyle A. Perry, MD
• Organization: The Ohio State University

kyle.perry@osumc.edu

614-293-5815

Study Officials

• Kyle Perry, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor General Surgery 614-293-5815

Study Record Dates

• First Submitted: January 5, 2012
• First Posted: January 16, 2012
• Study Start: August 1, 2011
• Primary Completion: July 1, 2012
• Study Completion: August 1, 2012
• Last Updated: March 5, 2014
• Results First Posted: March 5, 2014

Record last verified: 2014-01

Locations

US (1)