Aprepitant for Postoperative Nausea and Vomiting in Laparoscopic Hysterectomy

Postoperative Nausea and Vomiting Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01440673
• Other study ID #: GIRBA2085
• Status: Completed
• Phase: N/A
• First received: September 20, 2011
• Last updated: September 23, 2011
• Start date: March 2010
• Est. completion date: September 2010

Study information

• Verified date: September 2011
• Source: Gachon University Gil Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Nausea
• Postoperative Nausea and Vomiting
• Vomiting

Intervention

Drug:
• Aprepitant
Aprepitant 80 mg, Aprepitant 125 mg

Locations

Country	Name	City	State
Korea, Republic of	Gil Medical Center Gachon University	Inchon

Sponsors (3)

Lead Sponsor	Collaborator
Gachon University Gil Medical Center	Asan Medical Center, University of California, San Francisco

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The numbers (and percentages) of patients who experienced complete response	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	48 hours postoperatively	Yes