Home
Clinical Trials
Use of the Pressure Right Dev...

Use of the Pressure Right Device After Laparoscopic Surgery

Last Updated: 2011-03-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NO_LONGER_AVAILABLE

Study Classification

EXPANDED_ACCESS

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Post-Operative Therapy for Nausea or Vomiting

NCT03075163

Vomiting Nausea

TERMINATED PHASE4

Postoperative Nausea/Vomiting and Acupressure

NCT01389570

Postoperative Nausea

UNKNOWN PHASE2

Combination Antiemetic Regimen for Prevention of PONV in Breast Surgery Patients

NCT00738621

Postoperative Nausea and Vomiting

COMPLETED PHASE4

Dexamethasone for Postoperative Nausea and Vomiting

NCT00825071

Postoperative Nausea and Vomiting

COMPLETED PHASE4

Overnight Use of Electroacustimulation on Postoperative Nausea and Vomiting in the Outpatient Surgery Population

NCT01394536

Post-operative Nausea and Vomiting

WITHDRAWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Nausea Vomiting

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Acupressure

P 6 Pressure Point

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Pressure Right

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers