Study Stopped
The study was closed prior to enrollment of any subjects. No subjects were enrolled in this study.
Overnight Use of Electroacustimulation on Postoperative Nausea and Vomiting in the Outpatient Surgery Population
The Effect of Overnight Use of Electroacustimulation on Postoperative Nausea and Vomiting in the Outpatient Surgery Population
1 other identifier
interventional
N/A
1 country
1
Brief 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.
Trial Health
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1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2011
CompletedFirst Submitted
Initial submission to the registry
June 28, 2011
CompletedFirst Posted
Study publicly available on registry
July 14, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedOctober 17, 2012
October 1, 2012
11 months
June 28, 2011
October 16, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Measure of post-operative nausea and vomiting scores
The primary outcome will be post-operative nausea and vomiting scores on a scale of 1-10 based on surveys which will be performed at 30m, 60m, 120m, and 24h post-op.
24 hours
Secondary Outcomes (2)
Measure of amount of rescue nausea medications required
24 hours
Amount of time spent in recovery post-operatively
24 hours
Study Arms (2)
1
SHAM COMPARATOR"Sham" device - an EAS band placed over the P6 acupoint that will be turned off (inactive).
2
ACTIVE COMPARATORThe second arm will use the ReliefBand (Aeromedix, Jackson, WY), an FDA-approved, reusable, battery-operated electroacustimulation device.
Interventions
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).
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).
Eligibility Criteria
You may qualify if:
- scheduled for outpatient surgery procedure under general anesthesia
You may not qualify if:
- pregnancy
- currently experiencing menstrual symptoms
- cardiac pacemaker
- previous experience with acupuncture therapy
- pharmacologic treatment for nausea or vomiting in the 24 hours prior to surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Wisconsin-Madison
Madison, Wisconsin, 53792, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Benjamin Marcus, MD
University of Wisconsin, Madison
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 28, 2011
First Posted
July 14, 2011
Study Start
June 1, 2011
Primary Completion
May 1, 2012
Last Updated
October 17, 2012
Record last verified: 2012-10