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

This study has been completed.

First Received on April 8, 2008. Last Updated on September 3, 2010 History of Changes

Sponsor:	Drexel University College of Medicine
Collaborator:	Merck
Information provided by:	Drexel University
ClinicalTrials.gov Identifier:	NCT00659737

Purpose

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.

Condition	Intervention
Nausea Vomiting	Drug: Emend (Aprepitant) + Placebo Drug: Scopolamine + Emend (Aprepitant)

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Supportive Care
Official Title:	A Randomized, Double-blind Comparison of Oral Aprepitant Alone Versus Oral Aprepitant and Transdermal Scopolamine for Preventing Postoperative Nausea and Vomiting

Resource links provided by NLM:

MedlinePlus related topics: Nausea and Vomiting

Drug Information available for: Scopolamine Aprepitant Butylscopolammonium bromide Scopolamine Hydrobromide

U.S. FDA Resources

Further study details as provided by Drexel University:

Primary Outcome Measures:

The outcomes measured include the incidences of nausea, vomiting, and their composite, as well as the need for rescue medication, and incidence of unplanned hospital admission; finally, the duration of PACU stay serves as an additional outcome variable. [ Time Frame: Arrival at PACU, and 10, 20, 30, 40, 50, and 60 minutes after arrival. ] [ Designated as safety issue: No ]

Estimated Enrollment:	120
Study Start Date:	April 2008
Study Completion Date:	March 2010
Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 Oral Aprepitant pill and placebo transdermal patch at least 1 hour prior to surgical procedure.	Drug: Emend (Aprepitant) + Placebo 40mg tablet
Active Comparator: 2 Oral Aprepitant pill and Scopolamine transdermal patch at least 1 hour prior to surgical procedure.	Drug: Scopolamine + Emend (Aprepitant) 1.5 mg patch delivering transdermally in vivo approx. 1.0mg over 3 days

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patient must be between 18 and 65 years of age.
Patient's ASA 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
- Tolbutammide
- 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00659737

Locations

United States, Pennsylvania
Hahnemann University Hospital
Philadelphia, Pennsylvania, United States, 19102

Sponsors and Collaborators

Drexel University College of Medicine

Merck

Investigators

Study Director:

Jay Horrow, MD

Drexel University College of Medicine

More Information

No publications provided

Responsible Party:	Michael Green, DO, Drexel University College of Medicine
ClinicalTrials.gov Identifier:	NCT00659737 History of Changes
Other Study ID Numbers:	20071433
Study First Received:	April 8, 2008
Last Updated:	September 3, 2010
Health Authority:	United States: Institutional Review Board

Keywords provided by Drexel University:

Post-operative Nausea and Vomiting (PONV)

Additional relevant MeSH terms:

Nausea
Vomiting
Postoperative Nausea and Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Scopolamine
Butylscopolammonium Bromide
Aprepitant
Mydriatics
Autonomic Agents
Peripheral Nervous System Agents

Physiological Effects of Drugs
Pharmacologic Actions
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Parasympatholytics
Antiemetics
Gastrointestinal Agents

ClinicalTrials.gov processed this record on February 12, 2012