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OpenTrials
Completed

NCT Number: NCT00717054

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

The purpose of this study is to compare the incidence of nausea, vomiting, need for rescue medication, prolonged PACU time, and unplanned hospital admission in patients with high risk for post-operative nausea and vomiting (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

Aprepitant, a selective antagonist of neurokinin-1 (NK-1) receptors, blocks the emetic effects of substance P. NK-1 receptors are found on vagal afferents in the gastrointestinal tract and in the nucleus tractus solitaries in the brain. Substance P action on the NK-1 receptors in the central nervous system (CNS) is one of the final pathways to an emetic response.

Scopolamine antagonizes muscarinic type 1 (M1) and histamine type 1 (H1) receptors in the CNS, hypothalamus, and vomiting center. The noradrenergic system is also suppressed resulting in a diminished response to vestibular stimulation. Surgical procedures, opioids, and movement postoperatively all stimulate the vestibular system making scopolamine effective prophylaxis for PONV.

In adults undergoing general anesthesia with inhalational anesthetic agents, predictive risk factors for PONV include female sex, history of PONV or motion sickness, nonsmoking status, and the use of postoperative opioids. The frequency of PONV is 10% with zero, 21% with one, 39% with two, 61% with three, and 79% with 4 risk factors. The type of surgery also plays a major role. High risk procedures include intrabdominal, laparoscopic, orthopedic, major gynecologic, thyroid, otolaryngological, neurosurgical, breast, and plastic surgery.

Improving PONV prophylaxis would have a profound impact on patient care. Decreasing the incidence of nausea, vomiting, need for rescue medication, prolonged PACU time, and unplanned admissions is beneficial. Recent evidence suggests multiple drug therapy is superior to single agents. The correct preoperative treatment medication is instrumental in the outcome. This 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.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Between 18 and 65 years of age
  • American Society of Anesthesiology (ASA) physical status 1-3
  • If on oral contraceptive, must be willing to use back up method for 1 month
  • Must have 2 risk factors for PONV

Exclusion criteria

  • History of vomiting due to middle ear infection, nervous system disorder, or other condition
  • Procedure less than 1 hour
  • Pregnant or breast feeding
  • Antiemetic medication in previous 24 hours
  • Narrow-angle glaucoma
  • Allergic to belladonna alkaloids
  • Hypersensitive to barbiturates
  • Prostate hypertrophy
  • Severe hepatic disease
  • On chemotherapy taking aprepitant
  • Fever
  • Sepsis
  • Taking any of the following medications: Orap, Seldane, Hismanal, Propulsid, Phenytoin, Phenothiazines, Tricyclic antidepressants, Meperidine, Tolbutamide, Aluminum and Magnesium containing Antacids, Anti-cholinergics, Coumadin

Treatment and study plan

Aprepitant

Drug

Aprepitant 40mg PO one time at least one hour prior to induction of anesthesia

Other names: Emend

Scopolamine

Drug

Scopolamine transdermal applied to skin behind the ear one hour prior to surgery

Other names: Scopace, Transdermal scopolamine

Primary outcomes

  1. Number of Participants With Nausea and Vomiting

    Time frame: 24 hours postoperatively

Secondary outcomes

  1. Number of Participants With Nausea and Vomiting in PACU

    Time frame: Postoperatively, up to 2 hours

  2. Total Vomiting

    Time frame: 24 hours postoperatively

  3. Need for Antiemetic Medication

    Time frame: 24 hours postoperatively

Sponsors and collaborators

Lead sponsor

Drexel University

Other

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Jul 16, 2008
Registry last updated
May 20, 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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