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Use of the Pressure Right Device After Laparoscopic Surgery

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ClinicalTrials.gov Identifier: NCT01317082
Recruitment Status : No longer available
First Posted : March 17, 2011
Last Update Posted : March 17, 2011
Sponsor:
Information provided by:
Therapeutics: 101 Inc.

Brief Summary:
The primary objective is to test the hypothesis that the use of the Pressure Right device in combination with ondansetron and dexamethasone would result in a lower incidence of postoperative vomiting (emesis) than the combination of antiemetic therapy alone.

Condition or disease Intervention/treatment
Nausea Vomiting Device: Acupressure

Detailed Description:
The study design is a randomized, double-blinded and sham-controlled evaluation of the adjunctive Acupressure on the P6 point with Pressure Right to reduce the incidence of PONV and the need for rescue antiemetics leading to an improve quality of recovery after laparoscopic and ENT surgery. The two proposed study groups are: Group 1 (Sham-Control) 50 patients, will receive the sham Pressure Right (without acupressure button)30-45 min before induction of anesthesia and will be kept in place for 24h after discharge, and Group 2 (Pressure Right) 50 patients, will receive the Pressure Right device 30-45 min before induction of anesthesia and will be kept in place for 24h after discharge. In addition, all 100 study patients will receive a combination of antiemetics (ondansetron and dexamethasone) during the surgery.

Study Type : Expanded Access

Resource links provided by the National Library of Medicine

U.S. FDA Resources


Intervention Details:
    Device: Acupressure
    P 6 Pressure Point
    Other Name: Pressure Right

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  • Patients scheduled to undergo major laparoscopic and ENT surgery procedures under genertal anesthesia.
  • ASA Class I-III adults of either sex
  • Willingness and ability to sign an informed consent document.

Exclusion Criteria:

  • Patients with known allergy, hypersensitivity or contraindications to 5-HT3 antagonist.
  • Patients experienced vomiting or retching within 24 h before surgery.
  • Patients with clinically-significant medical conditions.
  • Pregnant and lactating women.

No Contacts or Locations Provided

Responsible Party: Paul White, Ph.D, M.D., White Mountain Institute
ClinicalTrials.gov Identifier: NCT01317082     History of Changes
Other Study ID Numbers: JDL20-11
First Posted: March 17, 2011    Key Record Dates
Last Update Posted: March 17, 2011
Last Verified: February 2011

Keywords provided by Therapeutics: 101 Inc.:
Postoperative Nausea & Vomiting.

Additional relevant MeSH terms:
Nausea
Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms