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

NCT ID: NCT00717054

Last Updated: 2014-05-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 115 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-02-29
• Study Completion Date: 2010-03-31

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.

Conditions

Nausea; Vomiting

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Aprepitant and Scopolamine group

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.

Group Type: ACTIVE_COMPARATOR

Aprepitant

Intervention Type: DRUG

Aprepitant 40mg PO one time at least one hour prior to induction of anesthesia

Scopolamine

Intervention Type: DRUG

Scopolamine transdermal applied to skin behind the ear one hour prior to surgery

Aprepitant and Scopolamine Placebo Group

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.

Group Type: PLACEBO_COMPARATOR

Scopolamine

Intervention Type: DRUG

Scopolamine transdermal applied to skin behind the ear one hour prior to surgery

Interventions

Aprepitant

Aprepitant 40mg PO one time at least one hour prior to induction of anesthesia

Intervention Type: DRUG

Scopolamine

Scopolamine transdermal applied to skin behind the ear one hour prior to surgery

Intervention Type: DRUG

Other Intervention Names

Emend; Scopace; Transdermal scopolamine

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

Drexel University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael S Green, DO

Role: PRINCIPAL_INVESTIGATOR

Drexel University College of Medicine

Locations

Hahnemann University Hospital

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

00659737

Identifier Type: -

Identifier Source: org_study_id