Aprepitant for Postoperative Nausea and Vomiting in Laparoscopic Hysterectomy

Not Applicable

Completed

• Conditions: Postoperative Nausea and Vomiting
• Interventions: Drug: Aprepitant

• Registration Number: NCT01440673
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2010-03
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Status Verified: 2011-09
• Study First Submitted: 2011-09-20
• Study First Submitted QC: 2011-09-23
• Last Update Submitted: 2011-09-23
• Study First Posted: 2011-09-26
• Last Update Posted: 2011-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 150

Inclusion Criteria

• female laparoscopic hysterectomy isoflurane anesthesia postoperative opioid use

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Exclusion Criteria

• liver disease neurologic disease active pulmonary disease cardiac arrhythmia allergies to any perioperative medications

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
aprepitant 125mg	Aprepitant	NK1 receptor antagonist
Aprepitant 80 mg	Aprepitant	-

Primary Outcome Measures

Name	Time	Method
The numbers (and percentages) of patients who experienced complete response	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

Trial Locations

Locations (1)

Gil Medical Center Gachon University; 🇰🇷 Inchon, Korea, Republic of