Postoperative Nausea and Vomiting
Conditions
Keywords
Elective hysterectomy
Brief summary
The purpose of the study is to determine whether 40 mg aprepitant administered before surgery is effective for preventing vomiting in the first 24 hours after surgery in women undergoing elective hysterectomy.
Detailed description
Postoperative nausea and vomiting (PONV) is the most frequent side effect after anesthesia, occurring in approximately 30% of unselected patients, and can be increased up to 70% in certain populations and procedures. Despite screening for patients at high risk for PONV, current prophylactic interventions fail to completely eliminate PONV for a substantial number of patients, leading to dehydration, electrolyte imbalance, prolonged hospitalizations, multiple doses of rescue therapy, and readmissions to the hospital (2). Aprepitant (Emend) is the first neurokin-1-receptor antagonist in a new class of antiemetics, which has already demonstrated powerful additive effects when combined with dexamethasone and a 5-HT3 to prevent both acute and delayed chemotherapy-induced nausea and vomiting (CINV). Early studies have also suggested it may useful in the prevention of postoperative nausea and vomiting (PONV). Patients undergoing elective inpatient or outpatient hysterectomy will be offered enrollment in this prospective, randomized, double blinded, placebo controlled trial. Subjects will receive Aprepitant vs. placebo prior to induction of standardized anesthesia. Postoperative nausea (assessed with a VRS), vomiting, and use of rescue antiemetic therapy will be documented over a 48h period. Additionally, hospitalization days and readmissions for PONV will be compared. Adverse events will be reported to the IRB and manufacturer. By reducing PONV in a group of high risk patients, we anticipate a demonstrated decrease in rescue antiemetic costs and hospitalization days for PONV related issues.
Interventions
DRUGAprepitant
40 mg administered orally with a sip of water prior to anesthesia induction.
DRUGPlacebo
Placebo
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Scheduled for elective hysterectomy at Mayo Clinic in Arizona * ASA I, II, or III
Exclusion criteria
* Pregnancy * Concomitant bowel surgery other than appendectomy * Hypersensitivity to study drug or rescue medication * Preoperative score for nausea greater than 4 out of 10 points * Severe hepatic insufficiency (Child-Pugh score \> 9) * Any condition which impairs the patient's ability to complete study assessments * Intraoperative hemodynamic instability * ICU admission * Prolonged postoperative intubation * Rifampin, carbamazepine, phenytoin, or other drugs which strongly induce CYP3A4 activity * Other antiemetic within 12 hours prior to surgery * Participation in a clinical trial using an investigational product
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Emesis | 24 hours after emergence from anesthesia | This is the number of participants who had an episode of vomiting within 24 hours after emergence from anesthesia. |
Countries
United States
Participant flow
Recruitment details
Enrollment began July 2007. Enrollment stopped October 2011 due to slow accrual.
Participants by arm
| Arm | Count |
|---|---|
| Aprepitant 40 mg aprepitant | 50 |
| Placebo Placebo | 70 |
| Total | 120 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 6 | 9 |
Baseline characteristics
| Characteristic | Aprepitant | Placebo | Total |
|---|---|---|---|
| Age Continuous | 60 years STANDARD_DEVIATION 12 | 53 years STANDARD_DEVIATION 12 | 56 years STANDARD_DEVIATION 12 |
| Sex: Female, Male Female | 50 Participants | 70 Participants | 120 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 15 / 34 | 20 / 37 |
| serious Total, serious adverse events | 3 / 34 | 2 / 37 |
Outcome results
Primary
Number of Participants With Emesis
This is the number of participants who had an episode of vomiting within 24 hours after emergence from anesthesia.
Time frame: 24 hours after emergence from anesthesia
Population: ITT. However, the primary outcome measure was not recorded for 84 participants in the Aprepitant group and 63 participants in the Placebo group.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Aprepitant | Number of Participants With Emesis | 6 participants |
| Placebo | Number of Participants With Emesis | 17 participants |