Nausea, Vomiting
Conditions
Keywords
Post-operative Nausea and Vomiting (PONV)
Brief summary
Recent evidence suggests multiple drug therapy is superior to single agents. The 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.
Detailed description
Postoperative nausea and vomiting (PONV) is a serious problem complicating surgery. PONV has an overall incidence of 30% and a 70% incidence in high-risk patients. PONV yields unplanned hospital admission, pulmonary aspiration, esophageal rupture, electrolyte abnormalities, dehydration, and delayed discharge from the postanesthesia care unit (PACU). Additional use of resources costs the health care industry hundreds of millions of dollars annually. Patient satisfaction is greatly improved when PONV is prevented.4 PONV etiology is multifactorial and the treatment is multimodal.
Interventions
DRUGAprepitant
40mg tablet
DRUGScopolamine
1.5 mg patch delivering transdermally in vivo approx. 1.0mg over 3 days
Sponsors
Merck Sharp & Dohme LLC
Drexel University College of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Patient must be between 18 and 65 years of age. * Patient's ASA (American Society of Anesthesiologist) class must be between 1 and 3. * If patient is currently on oral contraceptive to prevent pregnancy, she must be willing to use a back up form of birth control for one month post study. * Patient must have 1 FACTOR to qualify * Female Sex * History of PONV * Motion Sickness * Non-Smoker * Intended Use of Post Operative Opioids
Exclusion criteria
* Patients with a history of vomiting due to middle ear infection, nervous system disorder, or any other condition. * The surgical procedure is less than 1 hour. * The patient is pregnant or breast feeding. * The patient has taken antiemetic medication in previous 24 hours. * Patients with narrow-angle glaucoma. * Allergy to belladonna alkaloids. * Hypersensitivity to barbiturates. * Patient taking any of the following medications: * Orap * Seldane * Hismanal * Propulsid * Phenytoin * Phenothiazines * Tricyclic Antidepressants * Meperidine * Tolbutamide * Aluminum and Magnesium Trisilicate-containing Antacids * Anti-Cholinergics * Coumadin * Male patients with prostate hypertrophy. * Patients with severe hepatic disease. * Patients on Chemotherapy and taking Aprepitant. * Patients with fever. * Patients with sepsis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants With Postoperative Nausea and Vomiting | 0-24 hours |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Aprepitant and Placebo Transdermal Patch Oral Aprepitant pill, 40 mg tablet and placebo transdermal patch at least 1 hour prior to surgical procedure. | 57 |
| Aprepitant and Scopolamine Transdermal Patch Oral Aprepitant pill, 40 mg tablet and Scopolamine transdermal patch, 1.5 mg patch delivering transdermally in vivo approximately 1.0mg over 3 days, at least 1 hour prior to surgical procedure | 58 |
| Total | 115 |
Baseline characteristics
| Characteristic | Aprepitant and Placebo Transdermal Patch | Aprepitant and Scopolamine Transdermal Patch | Total |
|---|---|---|---|
| Age, Continuous | 47.2 Years STANDARD_DEVIATION 11.27 | 46.3 Years STANDARD_DEVIATION 11.06 | 46.8 Years STANDARD_DEVIATION 11.17 |
| Sex: Female, Male Female | 52 Participants | 51 Participants | 103 Participants |
| Sex: Female, Male Male | 5 Participants | 7 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 29 / 57 | 34 / 58 |
| serious Total, serious adverse events | 0 / 57 | 0 / 58 |
Outcome results
Primary
Number of Participants With Postoperative Nausea and Vomiting
Time frame: 0-24 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Aprepitant and Placebo Transdermal Patch | Number of Participants With Postoperative Nausea and Vomiting | 28 participants |
| Aprepitant and Scopolamine Transdermal Patch | Number of Participants With Postoperative Nausea and Vomiting | 34 participants |