Aprepitant for Prevention of Postoperative Nausea and Vomiting in Elective Hysterectomy

Postoperative Nausea and Vomiting Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00888329
• Other study ID #: 06-005478
• Status: Terminated
• Phase: Phase 4
• First received: April 24, 2009
• Last updated: March 5, 2012
• Start date: July 2007
• Est. completion date: October 2011

Study information

• Verified date: March 2012
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 256
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Nausea
• Postoperative Nausea and Vomiting
• Vomiting

Intervention

Drug:
• Aprepitant
40 mg administered orally with a sip of water prior to anesthesia induction.
• Placebo
Placebo

Locations

Country	Name	City	State
United States	Mayo Clinic	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Emesis	This is the number of participants who had an episode of vomiting within 24 hours after emergence from anesthesia.	24 hours after emergence from anesthesia	No