Expired Study
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Wynnewood, Pennsylvania 19096


Purpose:

The combination of aprepitant and lower dose dexamethasone is superior to aprepitant alone with respect to the proportion of patients with a complete response (no vomiting and no use of rescue therapy) during 24 hours after the placement of last suture/staple.


Study summary:

Postoperative Nausea and Vomiting (PONV) is a serious and common (50%-70%) complication of laparoscopic abdominal surgery. PONV is multifactorial, and the treatment is multimodal. Preoperative treatment should target the specific mechanism of PONV to minimize its incidence/consequences to the benefit of the patients. Aprepitant, a selective antagonist of neurokinin-1 (NK-1) receptors, blocks the emetic effects of substance P.5 Substance P action on the NK-1 receptors in the central nervous system (CNS) is one of the final pathways to an emetic response. Dexamethasone is an inexpensive and effective antiemetic drug with minimal side effects after a single-dose administration. The commonly used minimal effective dose is 8 to 10 mg, but the dose 5 mg is suggested for PONV in patients undergoing laparoscopic surgeries. Based on the literature review, occurrence of PONV does not significantly differ at dosing of Dexamethasone equal or higher than 4 mg. This study compares the incidence of nausea, vomiting, need for rescue medication, prolonged PACU time, and unplanned hospital admission in patients with high risk for PONV treated with oral aprepitant and dexamethasone or aprepitant alone preoperatively.


Criteria:

Inclusion Criteria: - at least 18 years old - ASA physical status I-III - must have at least 2 risk factors for PONV Exclusion Criteria: - pregnant or breast feeding patients - antiemetic medication in previous 24 hours - allergy or other contraindication to study medications


NCT ID:

NCT00835965


Primary Contact:

Principal Investigator
Dmitri Chamchad, MD
Lankenau Hospital, Lankenau Institute for Medical Research

Dmitri Chamchad, MD
Phone: 610-645-6866
Email: chamchad@hotmail.com


Backup Contact:

Email: MedvedM@MLHS.ORG
Mikhail Medved, PhD
Phone: 610-645-6866


Location Contact:

Wynnewood, Pennsylvania 19096
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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