Aprepitant PO vs Ondansetron IV for Prevention of Postoperative Nausea and Vomiting

This study has been withdrawn prior to enrollment.
(Logistical difficulties running the study)
Sponsor:
Information provided by (Responsible Party):
North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier:
NCT00699894
First received: June 16, 2008
Last updated: August 8, 2013
Last verified: August 2013
  Purpose

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 surgery.

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.


Condition Intervention
Postoperative Nausea and Vomiting
Drug: aprepitant 40 mg
Drug: ondansetron 4 mg

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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.

Resource links provided by NLM:


Further study details as provided by North Shore Long Island Jewish Health System:

Primary Outcome Measures:
  • No vomiting and use of rescue medications [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • no nausea based on verbal rating scale [ Time Frame: 0, 2, 6, 24 hours ] [ Designated as safety issue: No ]
  • time to first emetic episode [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • time to use of rescue medications [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: June 2008
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
aprepitant 40 mg + normal saline IV
Drug: aprepitant 40 mg
aprepitant 40 mg PO 1-3 hours prior to surgery
Other Name: emend 40 mg
Active Comparator: 2
placebo PO + ondansetron 4 mg IV
Drug: ondansetron 4 mg
ondansetron 4 mg IV 2-5 minutes prior to induction of anesthesia
Other Name: zofran 4 mg

  Eligibility

Ages Eligible for Study:   15 Years to 25 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00699894

Locations
United States, New York
Long Island Jewish Medical Center/Schneider's Children Hospital
New Hyde Park, New York, United States, 11040
Sponsors and Collaborators
North Shore Long Island Jewish Health System
Investigators
Principal Investigator: Christopher Choi, DDS Long Island Jewish Medical Center
  More Information

Publications:
Responsible Party: North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier: NCT00699894     History of Changes
Other Study ID Numbers: 07118
Study First Received: June 16, 2008
Last Updated: August 8, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by North Shore Long Island Jewish Health System:
PONV
prevention of postoperative nausea and vomiting
aprepitant
ondansetron
orthognathic surgery

Additional relevant MeSH terms:
Nausea
Vomiting
Postoperative Nausea and Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Ondansetron
Aprepitant
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Antipruritics
Dermatologic Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Anti-Anxiety Agents

ClinicalTrials.gov processed this record on April 14, 2014