Nausea Clinical Trial
Official title:
A Randomized, Double-blind Comparison of Oral Aprepitant Alone vs Oral 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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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