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Aprepitant for Postoperative Nausea and Vomiting in Laparoscopic Hysterectomy

This study has been completed.
Asan Medical Center
University of California, San Francisco
Information provided by (Responsible Party):
Wol Seon Jung, Gachon University Gil Medical Center Identifier:
First received: September 20, 2011
Last updated: September 23, 2011
Last verified: September 2011
  • 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.

Condition Intervention
Postoperative Nausea and Vomiting
Drug: Aprepitant

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

Resource links provided by NLM:

Further study details as provided by Gachon University Gil Medical Center:

Primary Outcome Measures:
  • The numbers (and percentages) of patients who experienced complete response [ Time Frame: 48 hours postoperatively ] [ Designated as safety issue: Yes ]
    • The numbers (and percentages) of patients who experienced complete response, i.e. no nausea, retching, vomiting, or need for rescue treatment
    • required rescue therapy and peak nausea scores
    • Adverse effects in the three treatment groups

Enrollment: 150
Study Start Date: March 2010
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: aprepitant 125mg
NK1 receptor antagonist
Drug: Aprepitant
Aprepitant 80 mg, Aprepitant 125 mg
Active Comparator: Aprepitant 80 mg Drug: Aprepitant
Aprepitant 80 mg, Aprepitant 125 mg

Detailed Description:

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.


Ages Eligible for Study:   21 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01440673

Korea, Republic of
Gil Medical Center Gachon University
Inchon, Korea, Republic of, 405-760
Sponsors and Collaborators
Gachon University Gil Medical Center
Asan Medical Center
University of California, San Francisco
Principal Investigator: WOL SEON JUNG, M.D. Ph.D. Gil Medical Center Gachon University
  More Information

No publications provided

Responsible Party: Wol Seon Jung, Associate professor, Gachon University Gil Medical Center Identifier: NCT01440673     History of Changes
Other Study ID Numbers: GIRBA2085
Study First Received: September 20, 2011
Last Updated: September 23, 2011
Health Authority: Korea: Institutional Review Board

Keywords provided by Gachon University Gil Medical Center:
Postoperative Nausea and Vomiting

Additional relevant MeSH terms:
Postoperative Nausea and Vomiting
Pathologic Processes
Postoperative Complications
Signs and Symptoms
Signs and Symptoms, Digestive
Autonomic Agents
Central Nervous System Agents
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Neurokinin-1 Receptor Antagonists
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses processed this record on February 27, 2015