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Aprepitant for Postoperative Nausea and Vomiting in Laparoscopic Hysterectomy

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ClinicalTrials.gov Identifier: NCT01440673
Recruitment Status : Completed
First Posted : September 26, 2011
Last Update Posted : September 26, 2011
Sponsor:
Collaborators:
Asan Medical Center
University of California, San Francisco
Information provided by (Responsible Party):
Wol Seon Jung, Gachon University Gil Medical Center

Brief Summary:
  • 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 or disease Intervention/treatment Phase
Postoperative Nausea and Vomiting Drug: Aprepitant Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Study Start Date : March 2010
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Aprepitant

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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



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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

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

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 Posted: September 26, 2011    Key Record Dates
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