Expired Study
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Philadelphia, Pennsylvania 19102


Purpose:

The purpose of this study is to compare 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 with or without transdermal scopolamine preoperatively.


Study summary:

Aprepitant, a selective antagonist of neurokinin-1 (NK-1) receptors, blocks the emetic effects of substance P. NK-1 receptors are found on vagal afferents in the gastrointestinal tract and in the nucleus tractus solitarius in the brain. Substance P action on the NK-1 receptors in the central nervous system (CNS) is one of the final pathways to an emetic response. Scopolamine antagonizes muscarinic type 1 (M1) and histamine type 1 (H1) receptors in the CNS, hypothalamus, and vomiting center. The noradrenergic system is also suppressed resulting in a diminished response to vestibular stimulation. Surgical procedures, opioids, and movement postoperatively all stimulate the vestibular system making scopolamine effective prophylaxis for PONV. In adults undergoing general anesthesia with inhalational anesthetic agents, predictive risk factors for PONV include female sex, history of PONV or motion sickness, nonsmoking status, and the use of postoperative opioids. The frequency of PONV is 10% with zero, 21% with one, 39% with two, 61% with three, and 79% with 4 risk factors. The type of surgery also plays a major role. High risk procedures include intraabdominal, laparoscopic, orthopedic, major gynecologic, thyroid, otolaryngotical, neurosurgical, breast, and plastic surgery. Improving PONV prophylaxis would have a profound impact on patient care. Decreasing the incidence of nausea, vomiting, need for rescue medication, prolonged PACU time, and unplanned admissions is beneficial. Recent evidence suggests multiple drug therapy is superior to single agents. The correct preoperative treatment medication is instrumental in the outcome. 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 with or without transdermal scopolamine preoperatively.


Criteria:

Inclusion Criteria: - Between 18 and 65 years of age - ASA physical status 1-3 - If on oral contraceptive, must be willing to use back up method for 1 month - Must have 2 risk factors for PONV Exclusion Criteria: - History of vomiting due to middle ear infection, nervous system disorder, or other condition - Procedure less than 1 hour - Pregnant or breast feeding - Antiemetic medication in previous 24 hours - Narrow-angle glaucoma - Allergic to belladonna alkaloids - Hypersensitive to barbiturates - Prostate hypertrophy - Severe hepatic disease - On chemotherapy taking aprepitant - Fever - Sepsis - Taking any of the following medications: Orap, Seldane, Hismanal, Propulsid, Phenytoin, Phenothiazines, Tricyclic antidepressants, Meperidine, Tolbutamide, Aluminum and Magnesium containing Antacids, Anti-cholinergics, Coumadin


NCT ID:

NCT00717054


Primary Contact:

Principal Investigator
Michael S Green, DO
Drexel University College of Medicine


Backup Contact:

N/A


Location Contact:

Philadelphia, Pennsylvania 19102
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: March 16, 2018

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