Aprepitant for Prevention of Postoperative Nausea and Vomiting in Elective Hysterectomy

This study has been terminated.
(Slow accrual.)
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00888329
First received: April 24, 2009
Last updated: March 5, 2012
Last verified: March 2012
  Purpose

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 Intervention Phase
Postoperative Nausea and Vomiting
Drug: Aprepitant
Drug: Placebo
Phase 4

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: Prevention of Postoperative Nausea and Vomiting in a Gynecologic Surgery Population: A Randomized Placebo Controlled Trial of Aprepitant NK-1-receptor Antagonist

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Number of Participants With Emesis [ Time Frame: 24 hours after emergence from anesthesia ] [ Designated as safety issue: No ]
    This is the number of participants who had an episode of vomiting within 24 hours after emergence from anesthesia.


Enrollment: 256
Study Start Date: July 2007
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Placebo
Drug: Placebo
Placebo

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00888329

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

No publications provided

Responsible Party: Jennifer Klauschie MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00888329     History of Changes
Other Study ID Numbers: 06-005478
Study First Received: April 24, 2009
Results First Received: February 1, 2012
Last Updated: March 5, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Elective hysterectomy

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

ClinicalTrials.gov processed this record on September 16, 2014