Nausea and Vomiting Post-foregut SurgeryReletexNCT01510379

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

A study testing Reletex, IV ondansetron 4 mg q 6 hours for a total of 4 doses and IV promethazine 25 mg q 6 hours prn in people with Nausea and Vomiting Post-foregut Surgery, run by Kyle A Perry at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 85 years
Conditions the study is for: Nausea and Vomiting Post-foregut Surgery
What is being tested?: Reletex, IV ondansetron 4 mg q 6 hours for a total of 4 doses and IV promethazine 25 mg q 6 hours prn
Type of treatment: Injection or infusion, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: 1 siteUnited States
Study dates: Aug 2011to Aug 2012
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

The Ohio State University Medical Center
Columbus, Ohio, 43210

Other trials in United States

About this study

Official title: Median Nerve Acustimulation Plus Medical Anti-emetic Therapy for Control Post-operative Nausea in Patients Undergoing Foregut Surgery: A Randomized Control Trial

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
Being tested: Reletex, IV ondansetron 4 mg q 6 hours for a total of 4 doses, IV promethazine 25 mg q 6 hours prn, Elixir promethazine 25 mg q 6 hours prn after discharge
Keywords: nausea, vomiting, post-operative, foregut surgery
Medical subject headings: Nausea, Vomiting

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ReletexDevice
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 dosesDrug
IV promethazine 25 mg q 6 hours prnDrug
Elixir promethazine 25 mg q 6 hours prn after dischargeDrug

Study groups in NCT01510379
Study group	Role	What they receive
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. Receives: 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. Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 24 hours

Secondary outcomes (1)

Quantify the Amounts of Phenergan Used Between the Two Groups.
Measured: one week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2011Aug 2012

First posted16 Jan 2012 (estimated)
Study startAug 2011
Primary completionJul 2012
Study completionAug 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Nausea and Vomiting Post-foregut SurgeryStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01510379
Sponsor's protocol ID: 2011H0236
Acronym: Reletex
Status last verified: Jan 2014
First submitted: 5 Jan 2012
Last updated: 5 Mar 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Study at a glance

From the registry record, last updated by the sponsor on 5 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Median Nerve Acustimulation Plus Medical Anti-emetic Therapy for Control Post-operative Nausea in Patients Undergoing Foregut Surgery: A Randomized Control Trial
ClinicalTrials.gov ID: NCT01510379
Acronym / sponsor ID: Reletex / 2011H0236
Conditions: Nausea and Vomiting Post-foregut Surgery
Keywords: nausea, vomiting, post-operative, foregut surgery
Study type: Interventional
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: Kyle A PerryUniversity, hospital or other
Study start: Aug 2011
Primary completion: Jul 2012 (actual)
Study completion: Aug 2012 (actual)
First posted: 16 Jan 2012 (estimated)
Results: Posted 5 Mar 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Reletex	Active comparator	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 dischargeReletex 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.
Control	Other	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 dischargeScheduled 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.

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ReletexNeurostimulation device for prevention/treatment of post-operative nausea and vomiting, Reletex arm.	Device	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

Primary outcome

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).

1 secondary outcome

Quantify the Amounts of Phenergan Used Between the Two Groups.
Time frame: one week

Results and safety

Results posted to the registry on 5 Mar 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Reletex	49	49
Control	51	51

Primary outcome: Comparison of Postoperative Nausea and Vomiting Scores Between Groups Treated With a ReletexTM Device and Those Without the Device.

Time frame: 24 hours. Mean (Standard Deviation). Unit: units on a scale

Measure	Reletex n = 49	Control n = 51
Value	1.81 (2.17)	2.03 (2.83)

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Reletex	0 of 49 (0%)	0 of 49 (0%)	Not reported
Control	0 of 51 (0%)	0 of 51 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Kyle Perry, MD principal investigator

Ohio State University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Comparison of Postoperative Nausea and Vomiting Scores Between Groups Treated With a ReletexTM Device and Those Without the Device. (time frame: 24 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01510379.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2014.