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Completed

NCT Number: NCT01440673

Aprepitant for Postoperative Nausea and Vomiting in Laparoscopic Hysterectomy

* 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.

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Key information

Conditions

Postoperative Nausea and Vomiting Nausea Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

21 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Gil Medical Center Gachon University

Inchon, 405-760, South Korea

About this study

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

  • 80mg aprepitant
  • 125mg aprepitant
  • placebo

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aprepitant

Drug

Aprepitant 80 mg, Aprepitant 125 mg

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Gachon University Gil Medical Center

Other

Collaborators

  • Asan Medical Center
  • University of California, San Francisco

Registry information

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Sep 26, 2011
Registry last updated
Sep 26, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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