Aprepitant for Prevention of Postoperative Nausea and Vomiting in Elective Hysterectomy
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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 |
- 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 |
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
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 |
Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Gastrointestinal Agents |
ClinicalTrials.gov processed this record on May 19, 2013