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Use of the Pressure Right Device After Laparoscopic Surgery

Primary Purpose

Nausea, Vomiting

Status
No longer available
Phase
Locations
Study Type
Expanded Access
Intervention
Acupressure
Sponsored by
Therapeutics: 101 Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Nausea focused on measuring Postoperative Nausea & Vomiting.

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All Sexes

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.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    March 15, 2011
    Last Updated
    March 15, 2011
    Sponsor
    Therapeutics: 101 Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01317082
    Brief Title
    Use of the Pressure Right Device After Laparoscopic Surgery
    Study Type
    Expanded Access

    2. Study Status

    Record Verification Date
    February 2011
    Overall Recruitment Status
    No longer available
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Therapeutics: 101 Inc.

    4. Oversight

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Nausea, Vomiting
    Keywords
    Postoperative Nausea & Vomiting.

    7. Study Design

    8. Arms, Groups, and Interventions

    Intervention Type
    Device
    Intervention Name(s)
    Acupressure
    Other Intervention Name(s)
    Pressure Right
    Intervention Description
    P 6 Pressure Point

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Eligibility 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.

    12. IPD Sharing Statement

    Learn more about this trial

    Use of the Pressure Right Device After Laparoscopic Surgery

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