Overnight Use of Electroacustimulation on Postoperative Nausea and Vomiting in the Outpatient Surgery Population
NCT ID: NCT01394536
Last Updated: 2012-10-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2011-06-30
Brief Summary
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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.
Detailed Description
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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.
Secondary outcomes will be the amount of rescue nausea medications required by the patients, time to discharge, subjective pain assessment and the impact of their symptoms on the activities of daily living since being discharged from the surgery center based on survey, and amount of narcotic received.
This project would also aim to reduce the amount of time patients spend in recovery post-operatively, reduce hospital admissions secondary to persistent nausea and vomiting, and educate students and trainees about alternative methods of treating and preventing postoperative nausea and vomiting.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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1
"Sham" device - an EAS band placed over the P6 acupoint that will be turned off (inactive).
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).
2
The second arm will use the ReliefBand (Aeromedix, Jackson, WY), an FDA-approved, reusable, battery-operated electroacustimulation 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).
Interventions
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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).
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).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* currently experiencing menstrual symptoms
* cardiac pacemaker
* previous experience with acupuncture therapy
* pharmacologic treatment for nausea or vomiting in the 24 hours prior to surgery
18 Years
89 Years
ALL
No
Sponsors
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University of Wisconsin, Madison
OTHER
Responsible Party
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Principal Investigators
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Benjamin Marcus, MD
Role: PRINCIPAL_INVESTIGATOR
University of Wisconsin, Madison
Locations
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University of Wisconsin-Madison
Madison, Wisconsin, United States
Countries
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Other Identifiers
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H-2010-0063
Identifier Type: -
Identifier Source: org_study_id