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

Study Overview
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Brief Summary
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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.

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

Conditions
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Postoperative Nausea and Vomiting

Intervention / Treatment
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* Drug: Aprepitant
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aprepitant group<br>We administrate aprepitant with small amount of water to aprepitant group in pre treatment room (Before patient get in the operating room) | Drug: Aprepitant<br>* We administrate aprepitant with small amount of water to aprepitant group in pre treatment room. (Before patient get in the operating room)And we administrate ondansetron 4mg to both group 20 minutes before the end of surgery.<br>* Other names: Emend;|
| Placebo Comparator: placebo group<br>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. | Drug: placebo<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence and severity of postoperative nausea and vomiting | 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. | upto 2 days after surgery | 

Secondary Outcome Measures

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