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

Yonsei University

Status and phase: Completed; Phase 4

Conditions: Postoperative Nausea and Vomiting

Treatments: Drug: Aprepitant; Drug: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01897337

3-2012-0076

Details and patient eligibility

About

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.

Enrollment: 125 patients

Sex: Female

Ages: 20 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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125 participants in 2 patient groups, including a placebo group

Aprepitant group

Experimental group

Description:

We administrate aprepitant with small amount of water to aprepitant group in pre treatment room (Before patient get in the operating room)

Treatment:

Drug: Aprepitant

placebo group

Placebo Comparator group

Description:

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.

Treatment:

Drug: placebo