The Effect of Combining Aprepitant With Ondansetron in High-risk Patients for Postoperative Nausea and Vomiting

Phase 4

Completed

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

• Registration Number: NCT01897337
• Lead Sponsor: Yonsei University

Brief Summary

PONV (Postoperative nausea and vomiting) is one of most common complications after general anesthesia. Female sex, history of PONV, motion sickness, nonsmoker status, use of volatile agents, duration of anesthesia, opioid administration and laparoscopic surgery are known as risk factors for developing PONV. In consequence, patients undergoing laparoscopic gynecologic surgery are at high risk for developing PONV. Most of these patients use fentanyl based IV-PCA. And it also causes PONV.

So, we should prevent PONV in these patients by using multimodal or combination therapy.

Aprepitant is a NK1 receptor antagonist.And it is used to prevent chemotherapy induced nausea and vomiting. Many studies using aprepitant to prevent PONV are in progress.

In this study, we investigate the effect of combining aprepitant with ondansetron in high-risk patients for PONV.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2013-07
• Study First Submitted: 2013-07-08
• Study First Submitted QC: 2013-07-08
• Last Update Submitted: 2013-07-08
• Study First Posted: 2013-07-11
• Last Update Posted: 2013-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 125

Inclusion Criteria

• Patient undergoing laparoscopic gynecologic surgery.
• Patient who takes fentanyl based IV PCA
• ASA class I-II

Exclusion Criteria

• allergy to aprepitant
• take another antiemetics before surgery
• decreased liver function
• psychological disease
• who cannot speak Korean
• take medicines that interacts with emend who do not agree to the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo group	placebo	Patient in placebo group will be given Placebo in the PTR. And we administrate ondansetron 4mg to both group 20 minutes before the end of surgery.
Aprepitant group	Aprepitant	We administrate aprepitant with small amount of water to aprepitant group in pre treatment room (Before patient get in the operating room)

Primary Outcome Measures

Name	Time	Method
incidence and severity of postoperative nausea and vomiting	upto 2 days after surgery	Severity of PONV will be measured by using verbal numerical rating scale (0-10).; Incidence of retching or vomiting will also be recorded upto 2 days after surgery.

Secondary Outcome Measures

Name	Time	Method
adverse event	upto 2 days after surgery	abdominal pain, headache, diziness, drowsiness, constipation, pruritus, etc
pain	upto 2 days after surgery	Pain is assessed with verbal numeric rating scale. (0-10)

Trial Locations

Locations (1)

Gangnam severance hospital; 🇰🇷 Seoul, Korea, Republic of