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

Nausea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00659737
• Other study ID #: 20071433
• Status: Completed
• Phase: N/A
• First received: April 8, 2008
• Last updated: May 1, 2014
• Start date: April 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

Recent evidence suggests multiple drug therapy is superior to single agents. The 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.

Description:

Postoperative nausea and vomiting (PONV) is a serious problem complicating surgery. PONV has an overall incidence of 30% and a 70% incidence in high-risk patients. PONV yields unplanned hospital admission, pulmonary aspiration, esophageal rupture, electrolyte abnormalities, dehydration, and delayed discharge from the postanesthesia care unit (PACU). Additional use of resources costs the health care industry hundreds of millions of dollars annually. Patient satisfaction is greatly improved when PONV is prevented.4 PONV etiology is multifactorial and the treatment is multimodal.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Patient must be between 18 and 65 years of age.

• Patient's ASA (American Society of Anesthesiologist) class must be between 1 and 3.

• If patient is currently on oral contraceptive to prevent pregnancy, she must be willing to use a back up form of birth control for one month post study.

• Patient must have 1 FACTOR to qualify

• Female Sex

• History of PONV

• Motion Sickness

• Non-Smoker

• Intended Use of Post Operative Opioids

Exclusion Criteria:

• Patients with a history of vomiting due to middle ear infection, nervous system disorder, or any other condition.

• The surgical procedure is less than 1 hour.

• The patient is pregnant or breast feeding.

• The patient has taken antiemetic medication in previous 24 hours.

• Patients with narrow-angle glaucoma.

• Allergy to belladonna alkaloids.

• Hypersensitivity to barbiturates.

• Patient taking any of the following medications:

• Orap

• Seldane

• Hismanal

• Propulsid

• Phenytoin

• Phenothiazines

• Tricyclic Antidepressants

• Meperidine

• Tolbutamide

• Aluminum and Magnesium Trisilicate-containing Antacids

• Anti-Cholinergics

• Coumadin

• Male patients with prostate hypertrophy.

• Patients with severe hepatic disease.

• Patients on Chemotherapy and taking Aprepitant.

• Patients with fever.

• Patients with sepsis.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Nausea
• Postoperative Nausea and Vomiting
• Vomiting

Intervention

Drug:
• Aprepitant
40mg tablet
• Scopolamine
1.5 mg patch delivering transdermally in vivo approx. 1.0mg over 3 days

Locations

Country	Name	City	State
United States	Hahnemann University Hospital	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Drexel University College of Medicine	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 Postoperative Nausea and Vomiting		0-24 hours	No