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Overnight Use of Electroacustimulation on Postoperative Nausea and Vomiting in the Outpatient Surgery Population

NCT01394536 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2012-10-17

No results posted yet for this study

Summary

Postoperative nausea and vomiting after outpatient surgery are significant sources of patient dissatisfaction. The prevention of postoperative nausea and vomiting (PONV) should be equally as important as prevention of pain because both are large sources of patient dissatisfaction and can necessitate admission after routine outpatient procedures.

None of the currently available pharmacological interventions are able to totally abolish PONV. The use of electroacustimulation is a useful adjunct in prevention of PONV, but has yet to be studied when the patient takes the device home with them after leaving an outpatient facility.

Conditions

  • Post-operative Nausea and Vomiting

Interventions

DEVICE

Battery-operated electroacustimulation device (Inactive)

In the sham arm, this device will not be turned on. The device to be used is the ReliefBand (Aeromedix, Jackson, Wy), an FDA-approved, reusable, battery-operated electroacustimulation device. The ReilefBand is a portable battery powered (lithium coin cells) device that is worn on the wrist like a watch. Two electrodes contact the skin with the aid of the application of electroconductive gel, and an electrical current of 25 mHz is transmitted through the skin. The device is applied at the Neiguan (P6) point, which is located on the inside of the wrist and is thought, in traditional Chinese medicine, to relieve nausea and vomiting (NV).

DEVICE

Battery-operated electroacustimulation device (Active)

The device to be used is the ReliefBand (Aeromedix, Jackson, Wy), an FDA-approved, reusable, battery-operated electroacustimulation device. The ReilefBand is a portable battery powered (lithium coin cells) device that is worn on the wrist like a watch. Two electrodes contact the skin with the aid of the application of electroconductive gel, and an electrical current of 25 mHz is transmitted through the skin. The device is applied at the Neiguan (P6) point, which is located on the inside of the wrist and is thought, in traditional Chinese medicine, to relieve nausea and vomiting (NV).

Sponsors & Collaborators

  • University of Wisconsin, Madison

    lead OTHER

Principal Investigators

  • Benjamin Marcus, MD · University of Wisconsin, Madison

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2012-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01394536 on ClinicalTrials.gov