A comparative study on dosing strategy of ramosetron to prevent postoperative nausea and vomiting in high-risk patients undergoing elective breast surgery
- Conditions
- Neoplasms
- Registration Number
- KCT0006186
- Lead Sponsor
- Asan Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- Female
- Target Recruitment
- 254
1.Female
2.Patients 20 to 70 years old
3.Body weight ? 45 kg
4.American Society of Anesthesiologist Physical Status 1, 2 or 3
5.Apfel simplified PONV risk score ? 3 (3 or more of the 4 items below)
•Female
•History of PONV and/or motion sickness
•Nonsmoking status
•Use of postoperative opioids
6.Patients undergoing elective breast surgery (breast-conserving surgery or mastectomy)
7Patients who signed a written informed consent
1.Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive urine pregnancy test
2.Patients with known hypersensitivity to ramosetron
3.Patients with known hypersensitivity to oxycodone
4.Clinically significant impairment of renal function, defined by estimated GFR < 60 ml/min or a need for hemodialysis
5.Family history of malignant hyperthermia
6.Patients who are considered by the investigator to be unsuitable to participate in the study for any other reason not mentioned in the inclusion and exclusion criteria
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Frequency of nausea, vomiting, or retching for 48 hours after the end of surgery
- Secondary Outcome Measures
Name Time Method -Severity of PONV assessed by Rhodes index for nausea, vomiting and retching at 6, 24, and 48 hours after the end of surgery (0-32) -Frequency and amount of rescue antiemetics usage for 48 hours after the end of surgery