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

Information source: Drexel University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Nausea; Vomiting

Intervention: Aprepitant (Drug); Scopolamine (Drug)

Phase: N/A

Status: Completed

Sponsored by: Drexel University

Official(s) and/or principal investigator(s):
Michael S Green, DO, Principal Investigator, Affiliation: Drexel University College of Medicine

Summary

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: Number of Participants With Nausea and Vomiting

Secondary outcome:

Number of Participants With Nausea and Vomiting in PACU

Total Vomiting

Need for Antiemetic Medication

Detailed description: 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.

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Hahnemann University Hospital, Philadelphia, Pennsylvania 19102, United States
Additional Information

Starting date: February 2008
Last updated: May 1, 2014

Page last updated: August 23, 2015

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