| Abstract: | ABSTRACT: BACKGROUND: The incidence of postoperative nausea and vomiting is 50% to 80% after neurosurgery. The common prophylactic treatment for postoperative nausea and vomiting is a triple therapy of droperidol (Inapsine), promethazine (Phenergan) and dexamethasone (Decadron). Newer, more effectives methods of prophylaxis are being investigated. We designed this prospective, double-blind, single center study to compare the efficacy of ondansetron (Zofran) to a neurokinin-1 antagonist, aprepitant (Emend), as a substitute for droperidol, in the prophylactic treatment of postoperative nausea and vomiting after neurosurgery. METHODS: After obtaining institutional review board approval, One hundred-seventy-six patients, 18-85 years of age with ASA I to III, who did not receive anti-emetics 24 hours before surgery and are expected to undergo general anesthesia for neurosurgery lasting longer than two hours were included in this study. After meeting the inclusion and exclusion criteria and providing written informed consent, patients will be randomly assigned in a 1:1 ratio to one of two treatment groups: aprepitant or ondansetron. Because ondansetron is given intravenously and aprepitant orally, patients will be given an oral or intravenous placebo to maintain the double blind. Patients will receive aprepitant 40 mg PO/placebo within 2 hours prior to induction. At induction, a combination of intravenous dexamethasone 10 mg, promethazine 25 mg and ondansetron 4 mg/placebo will be given. The primary outcome measures are the episodes and severity of nausea and vomiting; administration of rescue antiemetic; and opioid consumption for 120 hours postoperatively. Standard safety assessments will include adverse event reports, physical and laboratory data, awakening time and duration of recovery from anesthesia. Logistic regression will be used to test the efficacy of aprepitant compared to ondansetron with demographic characteristics as potential covariates in the model. For the number of rescue therapy treatments used during the postoperative period, a Wilcoxon rank sum test will be performed. DISCUSSION: The results of this comparative study will potentially identify an improved treatment regimen that will decrease the incidence and severity of postoperative nausea and vomiting in patients undergoing neurosurgery. This will serve to enhance patient recovery and overall satisfaction of neurosurgical patients in the immediate postoperative period. Registered at The Ohio State University Biomedical Sciences Institutional Review Board: Protocol Number: 2007H0053 KEYWORDS: aprepitant, postoperative nausea and vomiting, craniotomy, ondansetron. Word Count: 347. |
