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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aprepitant group | Experimental | We administrate aprepitant with small amount of water to aprepitant group in pre treatment room (Before patient get in the operating room) |
|
| placebo group | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aprepitant | Drug | 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. |
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yon Hee Shim | Yonsei University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gangnam severance hospital | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26694939 | Derived | Ham SY, Shim YH, Kim EH, Son MJ, Park WS, Lee JS. Aprepitant for antiemesis after laparoscopic gynaecological surgery: A randomised controlled trial. Eur J Anaesthesiol. 2016 Feb;33(2):90-5. doi: 10.1097/EJA.0000000000000242. |
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| ID | Term |
|---|---|
| D020250 | Postoperative Nausea and Vomiting |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009325 | Nausea |
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| ID | Term |
|---|---|
| D000077608 | Aprepitant |
| ID | Term |
|---|---|
| D009025 | Morpholines |
| D010078 | Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
| placebo | Drug | 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. |
|
| upto 2 days after surgery |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D014839 | Vomiting |