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

NCT ID: NCT00659737

Last Updated: 2014-05-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 115 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-04-30
• Study Completion Date: 2010-03-31

Brief 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.

Detailed 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.

Conditions

Nausea; Vomiting

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Aprepitant

Oral Aprepitant pill and placebo transdermal patch at least 1 hour prior to surgical procedure.

Emend (Aprepitant) + Placebo

Group Type: PLACEBO_COMPARATOR

Aprepitant

Intervention Type: DRUG

40mg tablet

Scopolamine

Oral Aprepitant pill and Scopolamine transdermal patch at least 1 hour prior to surgical procedure.

Group Type: ACTIVE_COMPARATOR

Scopolamine

Intervention Type: DRUG

1.5 mg patch delivering transdermally in vivo approx. 1.0mg over 3 days

Interventions

Aprepitant

40mg tablet

Intervention Type: DRUG

Scopolamine

1.5 mg patch delivering transdermally in vivo approx. 1.0mg over 3 days

Intervention Type: DRUG

Other Intervention Names

Emend (Aprepitant) + Placebo; Scopolamine + Emend (Aprepitant)

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

Drexel University College of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jay Horrow, MD

Role: STUDY_DIRECTOR

Drexel University College of Medicine

Locations

Hahnemann University Hospital

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

20071433

Identifier Type: -

Identifier Source: org_study_id