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Aprepitant for Postoperative Nausea and Vomiting in Laparoscopic Hysterectomy

This study has been completed.
Sponsor:
Collaborators:
Asan Medical Center
University of California, San Francisco
Information provided by (Responsible Party):
Wol Seon Jung, Gachon University Gil Medical Center
ClinicalTrials.gov Identifier:
NCT01440673
First received: September 20, 2011
Last updated: September 23, 2011
Last verified: September 2011
History of Changes
  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
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:

U.S. FDA Resources

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.

  Eligibility

Ages Eligible for Study:   21 Years to 60 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Wol Seon Jung, Associate professor, Gachon University Gil Medical Center
ClinicalTrials.gov 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:
Nausea
Vomiting
Postoperative Nausea and Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Aprepitant
 Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents

ClinicalTrials.gov processed this record on May 19, 2013