Postoperative Nausea and Vomiting
Conditions
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.
Interventions
DRUGAprepitant
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.
DRUGplacebo
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.
Sponsors
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
South Korea
Outcome results
None listed