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
About this trial
This is an expanded access trial for Nausea focused on measuring Postoperative Nausea & Vomiting.
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.
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
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
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Primary Completion Date
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Study Completion Date
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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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