Utility of Acupuncture in the Treatment of Postoperative Nausea and Vomiting in Ambulatory Surgery
NCT ID: NCT01442012
Last Updated: 2012-10-03
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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UNKNOWN
NA
270 participants
INTERVENTIONAL
2011-09-30
2013-04-30
Brief Summary
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Detailed Description
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The disease to be studied is Postoperative Nausea and Vomiting (PONV). PONV, described by some as "The Big Little Problem", has a great impact on patient´s satisfaction and the postoperative care needed. Considering the increase of outpatient surgery there is an expanding demand for effective PONV treatment to prevent delays in discharge or unplanned readmissions. The estimated annual costs of PONV in the U.S. per year are 100 million Dollars.
Approximately 75 million patients are anesthetized in the world annually. It is estimated that 20-30% of these patients experience PONV, reaching 80% in patients at high risk. This incidence of PONV has maintained despite the improvement in surgical and anesthetic techniques and advances in antiemetic pharmacology. Increasingly, acupuncture is becoming part of Western medicine as a complementary treatment. Acupuncture has been described to effectively reduce the symptoms of different diseases, including PONV.
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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Group A
Patients receive cutaneous stimulation and self-stimulation of acupuncture points Pericardium 6, Heart 7 and Stomach 25
Ear seeds
The investigators will use ear seeds to stimulate acupuncture points. The seeds will be applied when the patients are in the preoperative room. After the patients have been discharged, they will need to stimulate these points every eight hours for five minutes, and every time they have nausea and/or vomiting during the first three postoperative days.
Group B
Patients receive cutaneous stimulation and self-stimulation of acupuncture points Gall Bladder 34, Kidney 6 and Liver 3
Ear seeds
The investigators will use ear seeds to stimulate acupuncture points. The seeds will be applied when the patients are in the preoperative room. After the patients have been discharged, they will need to stimulate these points every eight hours for five minutes, and every time they have nausea and/or vomiting during the first three postoperative days.
Interventions
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Ear seeds
The investigators will use ear seeds to stimulate acupuncture points. The seeds will be applied when the patients are in the preoperative room. After the patients have been discharged, they will need to stimulate these points every eight hours for five minutes, and every time they have nausea and/or vomiting during the first three postoperative days.
Eligibility Criteria
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Inclusion Criteria
* ASA I-II patients who will undergo a surgical procedure under general anesthesia in an ambulatory setting.
* Patients who are anticipated to not require admission to the recovery room or intensive care unit.
* Patients who, according to clinical criteria of the acupuncturist physician, are likely to benefit from acupuncture.
* Patients with a sufficient educational level to complete the health questionnaires required in the study.
* Patients who have given their written informed consent to participate in the study.
Exclusion Criteria
* Patients who cannot respond to the questionnaires provided during the study.
* Patients with known hypersensitivity to the materials of the ear seeds.
18 Years
ALL
Yes
Sponsors
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Group G-6
NETWORK
Responsible Party
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Principal Investigators
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PAULA ORTIZ LUCAS, MD
Role: PRINCIPAL_INVESTIGATOR
GRUPO G6
Locations
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Fundacion Jimenez Diaz Hospital
Madrid, Madrid, Spain
Countries
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Central Contacts
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Facility Contacts
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PAULA ORTIZ LUCAS, MD
Role: primary
Other Identifiers
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GE6-ACU-2011-01
Identifier Type: -
Identifier Source: org_study_id