Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kyle A Perry, The Ohio State University
ClinicalTrials.gov Identifier:
NCT01510379
First received: January 5, 2012
Last updated: February 24, 2014
Last verified: January 2014
  Purpose

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 Intervention
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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Ohio State University:

Primary Outcome Measures:
  • Comparison of Postoperative Nausea and Vomiting Scores Between Groups Treated With a ReletexTM Device and Those Without the Device. [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    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. [ Time Frame: one week ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: August 2011
Study Completion Date: August 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01510379

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

No publications provided

Responsible Party: Kyle A Perry, Assistant Professor General Surgery 614-293-5815, The Ohio State University
ClinicalTrials.gov Identifier: NCT01510379     History of Changes
Other Study ID Numbers: 2011H0236
Study First Received: January 5, 2012
Results First Received: November 15, 2013
Last Updated: February 24, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Ohio State University:
nausea
vomiting
post-operative
foregut surgery

Additional relevant MeSH terms:
Nausea
Vomiting
Signs and Symptoms
Signs and Symptoms, Digestive
Diphenhydramine
Ondansetron
Promethazine
Anesthetics
Anesthetics, Local
Anti-Allergic Agents
Anti-Anxiety Agents
Antiemetics
Antipruritics
Antipsychotic Agents
Autonomic Agents
Central Nervous System Agents
Central Nervous System Depressants
Dermatologic Agents
Gastrointestinal Agents
Histamine Agents
Histamine Antagonists
Histamine H1 Antagonists
Hypnotics and Sedatives
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Sensory System Agents

ClinicalTrials.gov processed this record on November 20, 2014