Clinical trial NCT00659737: Comparison of Oral Aprepitant and Transdermal Scopolamine for Preventing Postoperative Nausea and Vomiting
Official title: A Randomized, Double-blind Comparison of Oral Aprepitant Alone Versus Oral Aprepitant and Transdermal Scopolamine for Preventing Postoperative Nausea and Vomiting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nausea
Vomiting
Keywords: Post-operative Nausea and Vomiting (PONV)
Lead sponsor: Drexel University
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2008-04-16
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Number of Participants With Postoperative Nausea and Vomiting
timeFrame: 0-24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Hahnemann University Hospital
state: Pennsylvania
Study officials:
affiliation: Drexel University College of Medicine
name: Jay Horrow, MD
role: STUDY_DIRECTOR
References: