Aprepitant for Prevention of Postoperative Nausea and Vomiting in Elective Hysterectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00888329
Recruitment Status : Terminated (Slow accrual.)
First Posted : April 27, 2009
Results First Posted : March 30, 2012
Last Update Posted : March 30, 2012
Information provided by:
Mayo Clinic

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.

Condition or disease Intervention/treatment Phase
Postoperative Nausea and Vomiting Drug: Aprepitant Drug: Placebo Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 256 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Prevention of Postoperative Nausea and Vomiting in a Gynecologic Surgery Population: A Randomized Placebo Controlled Trial of Aprepitant NK-1-receptor Antagonist
Study Start Date : July 2007
Actual Primary Completion Date : October 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Aprepitant
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Aprepitant
40 mg aprepitant
Drug: Aprepitant
40 mg administered orally with a sip of water prior to anesthesia induction.
Other Name: Emend
Placebo Comparator: Placebo
Drug: Placebo

Primary Outcome Measures :
  1. Number of Participants With Emesis [ Time Frame: 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00888329

United States, Arizona
Mayo Clinic
Phoenix, Arizona, United States, 85054
Sponsors and Collaborators
Mayo Clinic
Principal Investigator: Javier Magrina, MD Mayo Clinic

Responsible Party: Jennifer Klauschie MD, Mayo Clinic Identifier: NCT00888329     History of Changes
Other Study ID Numbers: 06-005478
First Posted: April 27, 2009    Key Record Dates
Results First Posted: March 30, 2012
Last Update Posted: March 30, 2012
Last Verified: March 2012

Keywords provided by Mayo Clinic:
Elective hysterectomy

Additional relevant MeSH terms:
Postoperative Nausea and Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Neurokinin-1 Receptor Antagonists
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action