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

Drexel University

Status: Completed

Conditions: Vomiting; Nausea

Treatments: Drug: Aprepitant; Drug: Scopolamine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00659737

20071433

Details and patient eligibility

About

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.

Full 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.

Enrollment: 115 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

115 participants in 2 patient groups, including a placebo group

Aprepitant

Placebo Comparator group

Description:

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

Treatment:

Drug: Aprepitant

Scopolamine

Active Comparator group

Description:

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

Treatment:

Drug: Scopolamine