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Aprepitant for Postoperative Nausea and Vomiting in Laparoscopic Hysterectomy

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01440673
Enrollment
150
Registered
2011-09-26
Start date
2010-03-31
Completion date
2010-09-30
Last updated
2011-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Nausea and Vomiting

Keywords

Postoperative Nausea and Vomiting

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.

Interventions

DRUGAprepitant

Aprepitant 80 mg, Aprepitant 125 mg

Sponsors

Asan Medical Center
CollaboratorOTHER
University of California, San Francisco
CollaboratorOTHER
Gachon University Gil Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
21 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The numbers (and percentages) of patients who experienced complete response48 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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026