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

Not Applicable

Completed

• Conditions: Nausea; Vomiting
• Interventions: Drug: Aprepitant; Drug: Scopolamine

• Registration Number: NCT00659737
• Lead Sponsor: Drexel University College of Medicine

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.

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-04-08
• Study First Submitted QC: 2008-04-14
• Study First Posted: 2008-04-16
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Status Verified: 2013-09
• Results First Submitted: 2014-03-27
• Results First Submitted QC: 2014-03-27
• Results First Posted: 2014-04-29
• Last Update Submitted: 2014-05-01
• Last Update Posted: 2014-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 115

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aprepitant	Aprepitant	Oral Aprepitant pill and placebo transdermal patch at least 1 hour prior to surgical procedure. Emend (Aprepitant) + Placebo
Scopolamine	Scopolamine	Oral Aprepitant pill and Scopolamine transdermal patch at least 1 hour prior to surgical procedure.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Postoperative Nausea and Vomiting	0-24 hours

Trial Locations

Locations (1)

Hahnemann University Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States