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OpenTrials
Completed

NCT Number: NCT00659737

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hahnemann University Hospital

Philadelphia, Pennsylvania, 19102, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Aprepitant

Drug

40mg tablet

Other names: Emend (Aprepitant) + Placebo

Scopolamine

Drug

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

Other names: Scopolamine + Emend (Aprepitant)

Primary outcomes

  1. Number of Participants With Postoperative Nausea and Vomiting

    Time frame: 0-24 hours

Sponsors and collaborators

Lead sponsor

Drexel University College of Medicine

Other

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Apr 16, 2008
Registry last updated
May 15, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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