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Aprepitant for Prevention of Postoperative Nausea and Vomiting in Elective Hysterectomy

NCT ID: NCT00888329

Last Updated: 2012-03-30

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

256 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2011-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Postoperative Nausea and Vomiting

Keywords

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Elective hysterectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Aprepitant

40 mg aprepitant

Group Type EXPERIMENTAL

Aprepitant

Intervention Type DRUG

40 mg administered orally with a sip of water prior to anesthesia induction.

Placebo

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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Aprepitant

40 mg administered orally with a sip of water prior to anesthesia induction.

Intervention Type DRUG

Placebo

Placebo

Intervention Type DRUG

Other Intervention Names

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Emend

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Mayo Clinic

Principal Investigators

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Javier Magrina, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic

Phoenix, Arizona, United States

Site Status

Countries

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United States

Other Identifiers

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06-005478

Identifier Type: -

Identifier Source: org_study_id