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Aprepitant for Postoperative Nausea and Vomiting in Laparoscopic Hysterectomy

NCT ID: NCT01440673

Last Updated: 2011-09-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2010-09-30

Brief Summary

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* Gynecological surgery is associated with a high incidence of postoperative nausea and vomiting.
* NK1 receptor antagonists such as aprepitant appear to be highly effective for treating acute and delayed emesis, and yet understanding of the efficacy of different doses of aprepitant is limited.
* We performed a prospective, randomized, double-blinded placebo-controlled study of 123 female adults scheduled for laparoscopic hysterectomy who received 80 mg aprepitant, 125 mg aprepitant, or a placebo.

Detailed Description

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123 female patients (ages 21-60) undergoing laparoscopic hysterectomy

1. 80mg aprepitant
2. 125mg aprepitant
3. placebo

Incidences of nausea, vomiting/retching, and use of rescue antiemetics were recorded at 0, 1, 2, 24, and 48 h after surgery.

Conditions

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Postoperative Nausea and Vomiting

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 125mg

NK1 receptor antagonist

Group Type ACTIVE_COMPARATOR

Aprepitant

Intervention Type DRUG

Aprepitant 80 mg, Aprepitant 125 mg

Aprepitant 80 mg

Group Type ACTIVE_COMPARATOR

Aprepitant

Intervention Type DRUG

Aprepitant 80 mg, Aprepitant 125 mg

Interventions

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Aprepitant

Aprepitant 80 mg, Aprepitant 125 mg

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* female laparoscopic hysterectomy isoflurane anesthesia postoperative opioid use

Exclusion Criteria

* liver disease neurologic disease active pulmonary disease cardiac arrhythmia allergies to any perioperative medications
Minimum Eligible Age

21 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Asan Medical Center

OTHER

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role collaborator

Gachon University Gil Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Wol Seon Jung

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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WOL SEON JUNG, M.D. Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Gil Medical Center Gachon University

Locations

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Gil Medical Center Gachon University

Inchon, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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GIRBA2085

Identifier Type: -

Identifier Source: org_study_id