NCT01317082

Use of the Pressure Right Device After Laparoscopic Surgery

• Status: No Longer Available
• Phase: —
• Study type: Expanded Access
• Enrollment: —
• Sponsor: Therapeutics: 101 Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: —

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.

Conditions

• Nausea
• Vomiting

Interventions

Type	Name	Description
DEVICE	Acupressure	P 6 Pressure Point

Timeline

• First posted: 2011-03-17
• Last updated: 2011-03-17