Aprepitant PO vs Ondansetron IV for Prevention of Postoperative Nausea and Vomiting
Information source: North Shore Long Island Jewish Health System
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Postoperative Nausea and Vomiting
Intervention: aprepitant 40 mg (Drug); ondansetron 4 mg (Drug)
Sponsored by: North Shore Long Island Jewish Health System
Official(s) and/or principal investigator(s):
Christopher Choi, DDS, Principal Investigator, Affiliation: Long Island Jewish Medical Center
Postoperative nausea and vomiting (PONV) persists as one of the more common complications of
surgery. Although rarely life-threatening, it is the postoperative outcome that is most
unfavorable to patients, even more undesirable than pain. Orthognathic surgery corrects
conditions of the jaws and face related to structure, growth, sleep apnea, bad bite, or
congenital malformations. The bones of the face and jaws are cut and placed in a new
position. There is a high rate of PONV in orthognathic surgery (56%). It is particularly
challenging to the patient as their jaws are kept closed together with wires or elastic
bands. Nausea in a patient with restricted mouth opening can be psychologically unnerving
and puts them at risk for fluid in their lungs.
Gan and colleagues showed a higher efficacy of aprepitant over ondansetron in preventing
PONV and nausea severity after open abdominal surgery. From this study, the FDA approved the
use of aprepitant for PONV prevention in patients >18 years of age. Gan suggested further
investigation in different populations.
Our randomized, double-blind, prospective study will compare the efficacy of aprepitant PO
versus ondansetron IV in a high risk setting for PONV: adolescents undergoing orthognathic
Our study will involve 200 consecutive, adolescent patients (ages 15-25) who will undergo at
least a Le Fort 1 osteotomy (upper jaw surgery) under general anesthesia and require
hospital admission for at least one night. We will exclude patients who are currently taking
medications that have interactions with aprepitant (pimozide, terfenadine, astemizole,
cisapride), those who have a known vomiting disorder such as bulimia, and those who have
vomited for any reason within 24 hours of surgery. The procedure will be performed by 5
surgeons and general anesthesia will be administered by 3 anesthesiologists at one
institution. A study coordinator, who will not be involved in the treatment, will create the
randomization schedule in order to ensure blindness. The patients will be randomized to
either of two groups: 1) aprepitant 40 mg PO 2) ondansetron 4 mg IV. Appropriate verbal and
written consent will be obtained by the priniciple investigator or surgeon.
On the day of the procedure, all patients will receive a pill (aprepitant or aprepitant
placebo) at least 1 hour prior to induction of anesthesia and an IV infusion (ondansetron or
saline) over 2-5 minutes prior to intubation. The timing and doses of medications will be
consistent with manufacturer's recommendations. An established protocol will ensure every
patient will receive the same anesthetic regiment. Patient's fluid status will be closely
monitored and hydrated appropriately according to known fluid balance calculations.
Efficacy will be assessed based on criteria set by Gan et al and will be based on the
presence/absence of a vomiting episode, use of rescue medication and subjective evaluation
of nausea. Patients will be monitored continuously in the PACU and on the hospital floor by
the caring team (nurse, resident, anesthesiologist, surgeon) for any emetic episode or use
of rescue therapy. An emetic episode is defined as an act of vomiting (oral expulsion of
stomach contents) or retching (non-productive vomiting). Nausea will be assessed at
intervals of 0, 2, 6, 24 hours after surgery with T0 being time of extubation. Patients will
rate nausea on a 11-point verbal rating scale, with 0 being "not nausea" to 10 being "the
worst nausea." Rescue medication will be offered if the patient has more than one episode of
vomiting or retching, if the patient has nausea lasting longer than 15 minutes, or if the
patient requests it for established nausea or vomiting.
Official title: Comparison of Aprepitant PO and Ondansetron IV for Prevention of Postoperative Nausea and Vomiting (PONV) in Patients Undergoing Orthognathic Surgery and General Anesthesia.
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Primary outcome: No vomiting and use of rescue medications
no nausea based on verbal rating scale
time to first emetic episode
time to use of rescue medications
Minimum age: 15 Years.
Maximum age: 25 Years.
- Patients aged 15-25 who have reached skeletal maturity and are scheduled for Le Fort
1 osteotomy as part of standard care.
- Capable of providing informed consent.
- Patients with hypersensitivity to medications contraindicated with aprepitant:
pimozide, terfenadine, astemizole, cisapride.
- Patients with a known vomiting disorder
- Patients who have vomited for any reason within 24 hours prior to surgery.
- Patients who are pregnant or nursing.
- Patients who are unable to provide informed consent.
Locations and Contacts
Long Island Jewish Medical Center/Schneider's Children Hospital, New Hyde Park, New York 11040, United States
Gan TJ, Apfel CC, Kovac A, Philip BK, Singla N, Minkowitz H, Habib AS, Knighton J, Carides AD, Zhang H, Horgan KJ, Evans JK, Lawson FC; Aprepitant-PONV Study Group. A randomized, double-blind comparison of the NK1 antagonist, aprepitant, versus ondansetron for the prevention of postoperative nausea and vomiting. Anesth Analg. 2007 May;104(5):1082-9, tables of contents.
Starting date: June 2008
Last updated: August 8, 2013