Use of the Pressure Right Device After Laparoscopic Surgery

Nausea Clinical Trial

Clinical Trial Details — Status: No longer available

Administrative data

• NCT number: NCT01317082
• Other study ID #: JDL20-11
• Status: No longer available
• Phase: N/A
• First received: March 15, 2011
• Last updated: March 15, 2011

Study information

• Verified date: February 2011
• Source: Therapeutics: 101 Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Expanded Access

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: No longer available
• Enrollment: 0
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

N/A

Related Conditions & MeSH terms

• Nausea
• Vomiting

Intervention

Device:
• Acupressure
P 6 Pressure Point

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Therapeutics: 101 Inc.