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

Nausea Clinical Trial

Official title:

A Randomized, Double-blind Comparison of Oral Aprepitant Alone vs Oral Aprepitant and Transdermal Scopolamine for Preventing Postoperative Nausea and Vomiting

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00717054
• Other study ID #: 00659737
• Status: Completed
• Phase: N/A
• First received: July 15, 2008
• Last updated: May 1, 2014
• Start date: February 2008
• Est. completion date: March 2010

Study information

• Verified date: September 2013
• Source: Drexel University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Nausea
• Postoperative Nausea and Vomiting
• Vomiting

Intervention

Drug:
• Aprepitant
Aprepitant 40mg PO one time at least one hour prior to induction of anesthesia
• Scopolamine
Scopolamine transdermal applied to skin behind the ear one hour prior to surgery

Locations

Country	Name	City	State
United States	Hahnemann University Hospital	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Drexel University	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Nausea and Vomiting		24 hours postoperatively	No
Secondary	Number of Participants With Nausea and Vomiting in PACU		Postoperatively, up to 2 hours	No
Secondary	Total Vomiting		24 hours postoperatively	No
Secondary	Need for Antiemetic Medication		24 hours postoperatively	No