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 PACUTotal 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
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