Comparison of Aprepitant Versus Aprepitant and Transdermal Scopolamine for Preventing Postoperative Nausea and Vomiting

Not Applicable

Completed

Conditions: Nausea
Vomiting

Interventions: Drug: Aprepitant
Drug: Scopolamine

Registration Number: NCT00717054

Lead Sponsor: Drexel University

Brief Summary: 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 post-operative nausea and vomiting (PONV) treated with oral aprepitant with or without transdermal scopolamine preoperatively.

Detailed Description: 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 solitaries 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 intrabdominal, laparoscopic, orthopedic, major gynecologic, thyroid, otolaryngological, 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 115

Inclusion Criteria

Between 18 and 65 years of age
American Society of Anesthesiology (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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aprepitant and Scopolamine group	Aprepitant	Patients receive aprepitant and scopolamine for prevention of postoperative nausea and vomiting then were followed through the post operative period looking for nausea, vomiting, composite, and rescue medication utilization. This was compared to patients receiving aprepitant and scopolamine placebo looking for a difference in incidence of events.
Aprepitant and Scopolamine group	Scopolamine	Patients receive aprepitant and scopolamine for prevention of postoperative nausea and vomiting then were followed through the post operative period looking for nausea, vomiting, composite, and rescue medication utilization. This was compared to patients receiving aprepitant and scopolamine placebo looking for a difference in incidence of events.
Aprepitant and Scopolamine Placebo Group	Scopolamine	Patients receiving aprepitant and placebo scopolamine for prevention of postoperative nausea and vomiting then followed through the post operative period looking for signs of nausea, vomiting, composite, and rescue medication utilization. This was compared to patients receiving aprepitant and scopolamine looking for a difference in incidence of events.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Nausea and Vomiting	24 hours postoperatively

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Nausea and Vomiting in PACU	Postoperatively, up to 2 hours
Total Vomiting	24 hours postoperatively
Need for Antiemetic Medication	24 hours postoperatively