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Aprepitant for Postoperative Nausea and Vomiting in Laparoscopic Hysterectomy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01440673
First Posted: September 26, 2011
Last Update Posted: September 26, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Asan Medical Center
University of California, San Francisco
Information provided by (Responsible Party):
Wol Seon Jung, Gachon University Gil Medical Center
  Purpose
  • 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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by Wol Seon Jung, Gachon University Gil Medical Center:

Primary Outcome Measures:
  • The numbers (and percentages) of patients who experienced complete response [ Time Frame: 48 hours postoperatively ]
    • 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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01440673


Locations
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
Investigators
Principal Investigator: WOL SEON JUNG, M.D. Ph.D. Gil Medical Center Gachon University
  More Information

Responsible Party: Wol Seon Jung, Associate professor, Gachon University Gil Medical Center
ClinicalTrials.gov Identifier: NCT01440673     History of Changes
Other Study ID Numbers: GIRBA2085
First Submitted: September 20, 2011
First Posted: September 26, 2011
Last Update Posted: September 26, 2011
Last Verified: September 2011

Keywords provided by Wol Seon Jung, Gachon University Gil Medical Center:
Postoperative Nausea and Vomiting

Additional relevant MeSH terms:
Nausea
Vomiting
Postoperative Nausea and Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Aprepitant
Fosaprepitant
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Neurokinin-1 Receptor Antagonists
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action