New PONV Controlled Study Evaluates the Prophylaxis Impact of a Disposable Acupressure Device (Pressure Right(R)) as Part of a Multi-Modal Antiemetic Strategy With Ondansetron and Dexamethasone After Major Laparoscopic Surgical Procedures at Cedars-Sinai Medical Center
TINTON FALLS, NJ — (Marketwire) — 03/25/09 — Therapeutics: 101 Inc. announces several clinical milestones, including its study data presented by senior staff of the Department of Anesthesiology, Cedars-Sinai Medical Center in Los Angeles, at the 2009 International Anesthesia Research Society (IARS) conference in San Diego, CA last week. As part of a multi-modal antiemetic strategy, a randomized, sham-controlled, and
double-blinded study was designed at Cedars-Sinai Medical Center to assess overall efficacy of Pressure Right®, a simple disposable acupressure device being introduced into clinical practice, in surgical patients considered moderate to high risk for postoperative nausea and vomiting (PONV); including, improved emesis control, as well as patient satisfaction of their PONV management, and patient recovery during the first 24, 48 and 72 hours after major laparoscopic surgery, when administered for prophylaxis in combination with ondansetron and dexamethasone.
To date, controversy still exists regarding optimal strategy for managing PONV in high-risk surgical populations. Following IRB-approval, 100 consenting ASA l-lll patients undergoing major laparoscopic procedures were randomly assigned to one of two treatment groups. A “sham” patch (Control) or Pressure Right® (Acupressure) device was placed on the P6 acupoint bilaterally at least 30 minutes before induction of anesthesia. All patients received a standardized general anesthetic consisting of propofol and desflurane, and local anesthesia at the incision site to minimize postoperative pain. A combination of ondansetron, 4 mg IV, and dexamethasone, 4 mg IV, was administered during surgery for antiemetic prophylaxis in both study groups.
Use of the Pressure Right® device in the Acupressure Group in combination with ondansetron and dexamethasone significantly reduced vomiting (10 vs. 26%) at (0-24 h), (p < 0.05 vs. Control Group), as well as enhancing patient satisfaction with PONV management (84 vs. 66%) and improving the quality of recovery scores at 48 h, compared with (Control Group) of ondansetron and dexamethasone alone, after laparoscopic surgery procedures.
The need for rescue antiemetics at 24 h after surgery (28 vs. 44%) showed improved results with the use of the Pressure Right® device, compared with the Control Group using a “sham” patch on the P6 acupoint bilaterally with ondansetron and dexamethasone.
According to Joseph DiLustro, President, Therapeutics: 101 Inc., “Clearly, the evidence-based findings demonstrate that the Pressure Right® device added significant benefit to drug prophylaxis as part of a multi-modal antiemetic strategy with ondansetron and dexamethasone. Further, the cost-benefit differential of Pressure Right® clearly supports its clinical use at a cost of under five dollars ($5.00) per patient, compared to expensive add-on antiemetic drugs used to increase emesis control, especially during these times of economic cut backs when hospitals will be looking for ways to trim budgets. Additionally, the disposable device is extremely useful in reducing the incidence of PONV 24 hours after discharge which is many hours after the antiemetic drugs have worn off.
“Our dedication to the clinical practice of acupressure has led us to achieve a better understanding of the clinical nature for the mechanism of action of the P6 acupoint site, based on an examination of how peripheral somatic sites work in the central nervous system and how they may affect the transmission of endorphin neurotransmitters. Our analysis advances the proposition that the P6 acupoint site may function as a somatic site and stimulate endorphin secretion, leading to inhibiting the release of neurotransmitters by nerve fibers to receptors that are responsible for PONV activity.
“At mid-year, we will release a large-scale clinical study, consisting of 340 pregnant women, conducted in Western Australia, involving the setting of normal labor and delivery, which has not been studied previously. It is designed to assess the efficacy of Pressure Right® in a randomized, double-blinded, sham-placebo controlled study, to control nausea and vomiting, where nausea and vomiting associated with labor and delivery is a common problem causing significant distress,” adds DiLustro.