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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00888329
Other study ID # 06-005478
Secondary ID
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


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
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