Use of the Pressure Right Device After Laparoscopic Surgery

• Conditions: Nausea; Vomiting

• Registration Number: NCT01317082
• Lead Sponsor: 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.

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 Timeline

• Status Verified: 2011-02
• Study First Submitted: 2011-03-15
• Study First Submitted QC: 2011-03-15
• Last Update Submitted: 2011-03-15
• Study First Posted: 2011-03-17
• Last Update Posted: 2011-03-17

Recruitment & Eligibility

• Status: NO_LONGER_AVAILABLE
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: EXPANDED_ACCESS
• Study Design: Not specified