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

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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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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