Clinical trial NCT00717054: Comparison of Aprepitant Versus Aprepitant and Transdermal Scopolamine for Preventing Postoperative Nausea and Vomiting
Official title: A Randomized, Double-blind Comparison of Oral Aprepitant Alone vs Oral Aprepitant and Transdermal Scopolamine for Preventing Postoperative Nausea and Vomiting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nausea
Vomiting
Keywords: postoperative nausea and vomiting
Lead sponsor: Drexel University
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2008-07-16
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: Number of Participants With Nausea and Vomiting
timeFrame: 24 hours postoperatively
Secondary outcomes:
measure: Number of Participants With Nausea and Vomiting in PACU
timeFrame: Postoperatively, up to 2 hours
measure: Total Vomiting
timeFrame: 24 hours postoperatively
measure: Need for Antiemetic Medication
timeFrame: 24 hours postoperatively
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Hahnemann University Hospital
state: Pennsylvania
Study officials:
affiliation: Drexel University College of Medicine
name: Michael S Green, DO
role: PRINCIPAL_INVESTIGATOR
References: