Use of the Pressure Right Device After Laparoscopic Surgery

Expanded access is no longer available for this treatment.
Sponsor:
Information provided by:
Therapeutics: 101 Inc.
ClinicalTrials.gov Identifier:
NCT01317082
First received: March 15, 2011
Last updated: NA
Last verified: February 2011
History: No changes posted
  Purpose

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 Intervention
Nausea
Vomiting
Device: Acupressure

Study Type: Expanded Access     What is Expanded Access?

Resource links provided by NLM:


Further study details as provided by Therapeutics: 101 Inc.:

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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications 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
Study First Received: March 15, 2011
Last Updated: March 15, 2011
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on September 18, 2014